Description/Indication
Nutramigen is an iron-fortified, hypoallergenic infant formula designed for infants who are allergic to the intact proteins in cow’s milk and soy formulas. Nutramigen has extensively hydrolyzed protein and is proven effective for managing colic due to cow's milk allergy.
Long-Term Usage: Nutramigen is designed to provide a sole source of nutrition for infants up to age 6 months, and provide a major source of nutrition through 12 months of age. Normally, in feeding infants, gradual introduction of solid foods after 4–6 months of age is an important developmental as well as nutritional step.
In cases of continued food allergies or intolerances, Nutramigen is sometimes used as a milk substitute in the diet of children beyond 12 months of age. When Nutramigen is used as a milk substitute beyond 12 months of age, the total calcium content of the diet should be assessed.
Extended use of Nutramigen (or other infant formulas) as a sole source of diet is most appropriately monitored by physicians and nutritionists on a case-by-case basis.
Product Features:
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Nutrients
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(Normal Dilution)
Per 100 Cal (5 fl oz) 2 fl oz RTU
Per 100 Cal (5 fl oz) 6 fl oz RTU
Per 100 Cal (5 fl oz) 8 fl oz RTU
Per 100 Cal (5 fl oz) 13 fl oz Conc
Per 100 Cal (5 fl oz) 32 fl oz
Per 100 mL 2 fl oz RTU
Per 100 mL 6 fl oz RTU
Per 100 mL 8 fl oz RTU
Per 100 mL 13 fl oz Conc
Per 100 mL 32 fl oz
Protein, g
2.8
2.8
2.8
2.8
2.8
1.89
1.89
1.89
1.89
1.89
Fat, g
5.3
5.3
5.3
5.3
5.3
3.6
3.6
3.6
3.6
3.6
Linoleic acid, mg
860
860
860
860
780
580
580
580
580
530
Carbohydrate, g
10.3
10.3
10.3
10.3
10.3
7
7
7
7
7
Water, g
133
133
133
133
133
90
90
90
90
90
Vitamins/Other Nutrients
Vitamin A, IU
300
300
300
300
300
200
200
200
200
200
Vitamin D, IU
50
50
50
50
50
34
34
34
34
34
Vitamin E, IU
2
2
2
2
2
1.35
1.35
1.35
1.35
1.35
Vitamin K, mcg
9
9
9
9
8
6.1
6.1
6.1
6.1
5.4
Thiamin (Vitamin B1), mcg
80
80
80
80
80
54
54
54
54
54
Riboflavin (Vitamin B2), mcg
90
90
90
90
90
61
61
61
61
61
Vitamin B6, mcg
60
60
60
60
60
41
41
41
41
41
Vitamin B12, mcg
0.3
0.3
0.3
0.3
0.3
0.2
0.2
0.2
0.2
0.2
Niacin, mcg
1000
1000
1000
1000
1000
680
680
680
680
680
Folic acid (Folacin), mcg
16
16
16
16
16
10.8
10.8
10.8
10.8
10.8
Pantothenic acid, mcg
500
500
500
500
500
340
340
340
340
340
Biotin, mcg
3
3
3
3
3
2
2
2
2
2
Vitamin C (Ascorbic acid), mg
12
12
12
12
12
8.1
8.1
8.1
8.1
8.1
Choline, mg
24
24
24
24
24
16.2
16.2
16.2
16.2
16.2
Inositol, mg
17
17
17
17
17
11.5
11.5
11.5
11.5
11.5
Minerals
Calcium, mg
94
94
94
94
94
64
64
64
64
64
Phosphorus, mg
52
52
52
52
52
35
35
35
35
35
Magnesium, mg
8
8
8
11
8
5.4
5.4
5.4
7.4
5.4
Iron, mg
1.8
1.8
1.8
1.8
1.8
1.22
1.22
1.22
1.22
1.22
Zinc, mg
1
1
1
1
1
0.68
0.68
0.68
0.68
0.68
Manganese, mcg
25
25
25
25
25
16.9
16.9
16.9
16.9
16.9
Copper, mcg
75
75
75
75
75
51
51
51
51
51
Iodine, mcg
15
15
15
15
15
10.1
10.1
10.1
10.1
10.1
Selenium, mcg
2.8
2.8
2.8
2.8
2.8
1.89
1.89
1.89
1.89
1.89
Sodium, mg
47
47
47
47
47
32
32
32
32
32
Potassium, mg
110
110
110
110
110
74
74
74
74
74
Chloride, mg
86
86
86
86
86
58
58
58
58
5
Product nutrient values and ingredients are subject to change. Please see product label for current information.
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Nutrient Facts
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Nutrient Density
20 Cal/fl oz 2 & 6 fl oz
20 Cal/fl oz 13 fl oz
20 Cal/fl oz 8 & 32 fl oz
RTU
Concentrate
RTU
Protein (% Calories)
11
11
11
Fat (% Calories)
48
48
48
Carbohydrate (% Calories)
41
41
41
Potential Renal Solute Load (mOsm/100 Calories)13
25
25
25
Potential Renal Solute Load (mOsm/100 mL)13
16.9
16.9
16.9
Osmolality (mOsm/kg water)
320
260
270
Osmolarity (mOsm/L)
290
230
240
Lactose-Free
Yes
Yes
Yes
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Product Forms
- Medicare Part B uses HCPCS (Healthcare Common Procedure Coding System) to group products
- Medicaid systems vary by state; some use HCPCS while others use NDC format code or systems of their own—contact your state provider for more information
- Private health insurance and managed care companies may use HCPCS, NDC format code or their own system—contact your provider for more information
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Product: Nutramigen®
Item #: 049811
Description: Concentrate
Unit Size: 13 fl oz can
Calories/Unit: 520
Product Yield/Unit (fl oz): 26
Case: 12 cans per case
HCPCS Code: B4161
NDC Format Code: 00087-0498-01 -
Product: Nutramigen
Item #: 143701
Description: RTU
Unit Size: 2 fl oz bottle
Calories/Unit: 40
Product Yield/Unit (fl oz): 2
Case: 48 bottles per case
HCPCS Code: B4161
NDC Format Code: 00087-1437-41 -
Product: Nutramigen
Item #: 429704
Description: RTU
Unit Size: 6 fl oz bottle
Calories/Unit: 120
Product Yield/Unit (fl oz): 6
Case: 24 bottles per case
HCPCS Code: B4161
NDC Format Code: 00087-5105-17 -
Product: Nutramigen
Item #: 148501
Description: RTU
Unit Size: 8 fl oz bottle
Calories/Unit: 160
Product Yield/Unit (fl oz): 8
Case: 24 bottles per case
HCPCS Code: B4161
NDC Format Code: 00087-5102-46 -
Product: Nutramigen
Item #: 169101
Description: RTU
Unit Size: 32 fl oz bottle
Calories/Unit: 640
Product Yield/Unit (fl oz): 32
Case: 6 bottles per case
HCPCS Code: B4161
NDC Format Code: 00087-5115-64
Nutramigen is available in ready-to-use liquid and concentrate.
When using this information, please note the following:
Coding systems and reimbursement allowable rates vary by payer:
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Composition
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Ingredients: Ready To Use (2 fl oz Nursette® bottle): Water (87%), corn syrup solids (5%), vegetable oil (palm olein, soy, coconut and high oleic sunflower oils) (3%), casein hydrolysate* (milk) (2%), modified corn starch (2%) and less than 1%: Mortierella alpina oil†, Crypthecodinium cohnii oil‡, carrageenan, vitamin A palmitate, vitamin D3, vitamin E acetate, vitamin K1, thiamin hydrochloride, riboflavin, vitamin B6 hydrochloride, vitamin B12, niacinamide, folic acid, calcium pantothenate, biotin, ascorbic acid, choline chloride, inositol, calcium carbonate, calcium phosphate, magnesium oxide, ferrous sulfate, zinc sulfate, manganese sulfate, cupric sulfate, sodium iodide, sodium selenite, sodium citrate, potassium citrate, potassium chloride, citric acid, taurine, L-cystine, L-tyrosine, L-tryptophan, L-carnitine.
Ingredients: Ready To Use (6 fl oz Nursette bottle): Water (87%), corn syrup solids (5%), vegetable oil (palm olein, coconut, soy and high oleic sunflower oils) (4%), casein hydrolysate* (milk) (2%), modified corn starch (2%) and less than 1%: Mortierella alpina oil†, Crypthecodinium cohnii oil‡, calcium phosphate, potassium citrate, calcium carbonate, potassium chloride, sodium citrate, magnesium oxide, ferrous sulfate, zinc sulfate, cupric sulfate, manganese sulfate, sodium iodide, sodium selenite, carrageenan, choline chloride, ascorbic acid, vitamin E acetate, niacinamide, calcium pantothenate, vitamin A palmitate, thiamin hydrochloride, riboflavin, vitamin D3, vitamin B6 hydrochloride, folic acid, vitamin K1, biotin, L-cystine, inositol, L-tyrosine, L-tryptophan, vitamin B12, taurine, L-carnitine.
Ingredients: Ready To Use (8 fl oz bottle): Water (87%), corn syrup solids (5%), vegetable oil (palm olein, coconut, soy and high oleic sunflower oils) (3%), casein hydrolysate* (milk) (2%), modified corn starch (2%) and less than 1%: Mortierella alpina oil†, Crypthecodinium cohnii oil‡, calcium phosphate, potassium citrate, calcium carbonate, potassium chloride, sodium citrate, magnesium oxide, ferrous sulfate, zinc sulfate, cupric sulfate, manganese sulfate, sodium iodide, sodium selenite, carrageenan, citric acid, choline chloride, ascorbic acid, vitamin E acetate, niacinamide, calcium pantothenate, vitamin A palmitate, thiamin hydrochloride, riboflavin, vitamin D3, vitamin B6 hydrochloride, folic acid, vitamin K1, biotin, L-cystine, inositol, L-tyrosine, L-tryptophan, vitamin B12, taurine, L-carnitine.
Ingredients: Ready To Use (32 fl oz bottle): Water (87%), corn syrup solids (5%), vegetable oil (palm olein, soy, coconut, and high oleic sunflower oils) (4%), casein hydrolysate* (milk) (2%), modified corn starch (2%) and less than 1%: Mortierella alpina oil†, Crypthecodinium cohnii oil‡, carrageenan, vitamin A palmitate, vitamin D3, vitamin E acetate, vitamin K1, thiamin hydrochloride, riboflavin, vitamin B6 hydrochloride, vitamin B12, niacinamide, folic acid, calcium pantothenate, biotin, ascorbic acid, choline chloride, inositol, calcium carbonate, calcium phosphate, magnesium oxide, ferrous sulfate, zinc sulfate, manganese sulfate, cupric sulfate, potassium iodide, sodium selenite, sodium citrate, potassium citrate, potassium chloride, citric acid, taurine, L-cystine, L-tyrosine, L-tryptophan, L-carnitine.
Ingredients: (13 fl oz can): Water (75%), corn syrup solids (10%), vegetable oil (palm olein, soy, coconut and high oleic sunflower oils) (7%), casein hydrolysate* (milk) (4%), modified corn starch (3%) and less than 1%: Mortierella alpina oil†, Crypthecodinium cohnii oil‡, acetylated monoglycerides, carrageenan, vitamin A palmitate, vitamin D3, vitamin E acetate, vitamin K1, thiamin hydrochloride, riboflavin, vitamin B6 hydrochloride, vitamin B12, niacinamide, folic acid, calcium pantothenate, biotin, ascorbic acid, choline chloride, inositol, calcium carbonate, calcium phosphate, magnesium oxide, ferrous sulfate, zinc sulfate, manganese sulfate, cupric sulfate, sodium iodide, sodium selenite, sodium citrate, potassium citrate, potassium chloride, citric acid, taurine, L-cystine, L-tyrosine, L-tryptophan, L-carnitine.
* Modified to be better tolerated in milk-allergic babies.
† A source of arachidonic acid (ARA).
‡ A source of docosahexaenoic acid (DHA).
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Potential Allergens
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Nutramigen contains milk and soy. Nutramigen is hypoallergenic. Rarely, however, allergic reactions to extensively hydrolyzed casein formulas have been reported.
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Amino Acid Composition
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ESSENTIAL AMINO ACIDS mg/100 Cal mg/100 g Pwd Histidine 84 — Isoleucine 162 — Leucine 270 — Lysine 240 — Methionine 73 — Cysteine 48 — Phenylalanine 137 — Tyrosine 59 — Threonine 129 — Tryptophan 46 — Valine 200 — NONESSENTIAL AMINO ACIDS mg/100 Cal mg/100 g Pwd Arginine 112 — Alanine 95 — Aspartic Acid 210 — Glutamic Acid 640 — Glycine 59 — Proline 290 — Serine 162 — Tyrosine 59 — Threonine 129 — Tryptophan 46 — Valine 200 —
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Preparation of Feedings
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Concentrate
The baby’s health depends on carefully following the instructions below. Use only as directed by a medical professional. Proper hygiene, preparation, dilution, use and storage are important when preparing infant formula. Discuss with parents which formula is appropriate for the baby.
13 fl oz Cans
- Wash hands thoroughly with soap and water before preparing formula.
- Clean can lid, SHAKE CAN WELL and open.
- Pour desired amount of water into the bottle. Add an equal amount of concentrated liquid. Shake or stir well.
WARNING: Do not use a microwave oven to warm formula. Serious burns may
result.
Failure to follow these instructions could result in severe harm. Opened bottles or cans and prepared formula can spoil quickly. Either feed immediately or cover and store in refrigerator at 35–40°F (2–4°C) for no longer than 48 hours. Do not use opened containers and/or prepared formula if they are unrefrigerated for more than a total of 2 hours. Do not freeze prepared formula. After feeding begins, use prepared formula within 1 hour or discard. -
Nursette<sup>®</sup> Bottles
The baby’s health depends on carefully following the instructions below. Use only as directed by a medical professional. Proper hygiene, preparation, use and storage are important when preparing infant formula. Discuss with parents which formula is appropriate for the baby.
2 & 6 fl oz Nursette® Bottles
- Inspect each bottle for signs of damage.
- Wash hands thoroughly with soap and water before preparing bottle for feeding.
- SHAKE BOTTLE WELL and remove cap.
- Attach nipple unit (not included).
WARNING: Do not use a microwave oven to warm formula. Serious burns may
result.
Failure to follow these instructions could result in severe harm. Opened bottles can spoil quickly. Either feed immediately or replace cap and store in refrigerator at 35–40°F (2–4°C) for no longer than 24 hours. Do not use opened bottle if it is unrefrigerated for more than a total of 2 hours. Do not freeze. After feeding begins, use formula within 1 hour or discard. -
Ready-to-Use
The baby’s health depends on carefully following the instructions below. Use only as directed by a medical professional. Proper hygiene, preparation, use and storage are important when preparing infant formula. Discuss with parents which formula is appropriate for the baby.
8 fl oz Bottles
- Wash hands thoroughly with soap and water before preparing feeding bottles.
- SHAKE BOTTLE WELL, remove protective seal around cap, remove cap and foil seal.
- Pour into feeding bottle(s).
32 fl oz Bottles
- Wash hands thoroughly with soap and water before preparing feeding bottles.
- SHAKE BOTTLE WELL, remove protective seal around cap, remove cap and foil seal. Replace cap.
- Pour into feeding bottle(s).
WARNING: Do not use a microwave oven to warm formula. Serious burns may
result.
Failure to follow these instructions could result in severe harm. Opened bottles and prepared formula can spoil quickly. Either feed immediately or cover and store in refrigerator at 35–40°F (2–4°C) for no longer than 48 hours. Do not use opened bottle and/or prepared formula if they are unrefrigerated for more than a total of 2 hours. Do not freeze prepared formula. After feeding begins, use prepared formula within 1 hour or discard.
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References
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- Lothe L, Lindberg T. Cow’s milk whey protein elicits symptoms of infantile colic in colicky formula-fed infants: a double-blind crossover study. Pediatrics. 1989;83:262-266.
- Lothe L, Lindberg T, Jakobsson I. Cow’s milk formula as a cause of infantile colic: a double-blind study. Pediatrics. 1982;70:7-10.
- Birch EE, Hoffman DR, Uauy RD, et al. Visual acuity and the essentiality of docosahexaenoic acid and arachidonic acid in the diet of term infants. Pediatr Res. 1998;44:201-209.
- Birch EE, Garfield S, Hoffman DR, et al. A randomized controlled trial of early dietary supply of long-chain polyunsaturated fatty acids and mental development in term infants. Dev Med Child Neurol. 2000;42:174-181.
- Birch EE, Hoffman DR, Castañeda YS, et al. A randomized controlled trial of long-chain polyunsaturated fatty acid supplementation of formula in term infants after weaning at 6 wk of age. Am J Clin Nutr. 2002;75:570-580.
- Hoffman DR, Birch EE, Castañeda YS, et al. Visual function in breast-fed term infants weaned to formula with or without long-chain polyunsaturates at 4 to 6 months: a randomized clinical trial. J Pediatr. 2003;142:669-677.
- Hoffman DR, Birch EE, Castañeda YS, et al. Maturation of visual and mental function in 18-month-old infants receiving dietary long-chain polyunsaturated fatty acids (LCPUFAs) [abstract]. FASEB J. 2003;17:A727-A728. Abstract 445.1.
- Hoffman DR, Birch EE, Birch DG, et al. Impact of early dietary intake and blood lipid composition of long-chain polyunsaturated fatty acids on later visual development. J Pediatr Gastroenterol Nutr. 2000;31:540-553.
- Birch EE, Castañeda YS, Wheaton DH, et al. Visual maturation of term infants fed long-chain polyunsaturated fatty acid-supplemented or control formula for 12 mo. Am J Clin Nutr. 2005;81:871-879.
- Morale SE, Hoffman DR, Castañeda YS, et al. Duration of long-chain polyunsaturated fatty acids availability in the diet and visual acuity. Early Hum Dev. 2005;81:197-203.
- Innis SM. Human milk and formula fatty acids. J Pediatr. 1992;120(suppl): S56-S61.
- Jensen RG, ed. Handbook of Milk Composition. San Diego, Calif: Academic Press;1995.
- Fomon SJ, Ziegler EE. Renal solute load and potential renal solute load in infancy. J Pediatr. 1999;134:11-14.
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Consumer Reviews
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Letter of Medical Necessity for Nutramigen® with Enflora™ LGG®*
Insurance companies are not required to cover exempt infant formula or medical foods, but some do. This letter establishes a medical need for the product and might help get your patients insurance company to reimburse them for the product.