FDA Orange Book
Generic for Infuvite Pediatric
Infuvite Pediatric contains ascorbic acid, biotin, cholecalciferol, cyanocobalamin, dexpanthenol, folic acid, niacinamide, pyridoxine, riboflavin, thiamine, tocopherol acetate, vitamin a and vitamin k. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Infuvite Pediatric is ascorbic acid, biotin, cholecalciferol, cyanocobalamin, dexpanthenol, folic acid, niacinamide, pyridoxine, riboflavin, thiamine, tocopherol acetate, vitamin a and vitamin k. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
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Infuvite Pediatric products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, intravenous | 80MG/VIAL;0.02MG/VIAL;400 IU/VIAL;0.001MG/VIAL;5MG/VIAL;0.14MG/VIAL;17MG/VIAL;1MG/VIAL;1.4MG/VIAL;1.2MG/VIAL;7 IU/VIAL;2,300 IU/VIAL;0.2MG/VIAL | Marketed (Rx) | AP | 2 | AP |
NDA 021265, held by SANDOZ CANADA INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic ascorbic acid, biotin, cholecalciferol, cyanocobalamin, dexpanthenol, folic acid, niacinamide, pyridoxine, riboflavin, thiamine, tocopherol acetate, vitamin a and vitamin k
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| APOTEX INC | 210671 | AP (A-rated, therapeutically equivalent) | April 21, 2026 | 80MG/VIAL;0.02MG/VIAL;400 IU/VIAL;0.001MG/VIAL;5MG/VIAL;0.14MG/VIAL;17MG/VIAL;1MG/VIAL;1.4MG/VIAL;1.2MG/VIAL;7 IU/VIAL;2,300 IU/VIAL;0.2MG/VIAL |
| APOTEX INC | 210456 | AP (A-rated, therapeutically equivalent) | April 21, 2026 | 80MG/VIAL;0.02MG/VIAL;400 IU/VIAL;0.001MG/VIAL;5MG/VIAL;0.14MG/VIAL;17MG/VIAL;1MG/VIAL;1.4MG/VIAL;1.2MG/VIAL;7 IU/VIAL;2,300 IU/VIAL;0.2MG/VIAL |
Infuvite Pediatric NDC codes
Questions
Is there a generic for Infuvite Pediatric?
Yes. The generic name for Infuvite Pediatric is ascorbic acid, biotin, cholecalciferol, cyanocobalamin, dexpanthenol, folic acid, niacinamide, pyridoxine, riboflavin, thiamine, tocopherol acetate, vitamin a and vitamin k. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
What is the generic name for Infuvite Pediatric?
The active ingredient in Infuvite Pediatric is ascorbic acid, biotin, cholecalciferol, cyanocobalamin, dexpanthenol, folic acid, niacinamide, pyridoxine, riboflavin, thiamine, tocopherol acetate, vitamin a and vitamin k, per the FDA Orange Book.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.