FDA Orange Book
Generic for Vi-twel
Vi-twel contains cyanocobalamin. 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 Vi-twel is cyanocobalamin. 14 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
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Vi-twel products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | 1MG/ML | Discontinued | None | 15 | AP |
NDA 007012, held by BAYER HEALTHCARE PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic cyanocobalamin
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| SOMERSET THERAPEUTICS LLC | 206503 | AP (A-rated, therapeutically equivalent) | December 11, 2015 | 1MG/ML |
| H2-PHARMA LLC | 209255 | AP (A-rated, therapeutically equivalent) | December 18, 2018 | 1MG/ML |
| SOMERSET THERAPEUTICS LLC | 209429 | AP (A-rated, therapeutically equivalent) | December 18, 2018 | 1MG/ML |
| GLAND PHARMA LTD | 214390 | AP (A-rated, therapeutically equivalent) | September 24, 2020 | 1MG/ML |
| EUGIA PHARMA SPECIALITIES LTD | 213874 | AP (A-rated, therapeutically equivalent) | December 8, 2020 | 1MG/ML |
| SANDOZ INC | 212915 | AP (A-rated, therapeutically equivalent) | January 4, 2021 | 1MG/ML |
| SOLA PHARMACEUTICALS | 215417 | AP (A-rated, therapeutically equivalent) | April 15, 2022 | 1MG/ML |
| ZYDUS PHARMACEUTICALS USA INC | 214655 | AP (A-rated, therapeutically equivalent) | April 15, 2022 | 1MG/ML |
| SAGENT PHARMACEUTICALS INC | 215107 | AP (A-rated, therapeutically equivalent) | November 15, 2022 | 1MG/ML |
| MANKIND PHARMA LTD | 217839 | AP (A-rated, therapeutically equivalent) | July 10, 2024 | 1MG/ML |
| MEITHEAL PHARMACEUTICALS INC | 214316 | AP (A-rated, therapeutically equivalent) | November 15, 2024 | 1MG/ML |
| ASPIRO PHARMA LTD | 219820 | AP (A-rated, therapeutically equivalent) | July 8, 2026 | 1MG/ML |
| AMERICAN REGENT INC | 080737 | AP (A-rated, therapeutically equivalent) | Approved Prior to Jan 1, 1982 | 1MG/ML |
| WEST-WARD PHARMACEUTICALS INTERNATIONAL LTD | 080515 | AP (A-rated, therapeutically equivalent) | Approved Prior to Jan 1, 1982 | 1MG/ML |
| FRESENIUS KABI USA LLC | 080557 | AP (A-rated, therapeutically equivalent) | Approved Prior to Jan 1, 1982 | 1MG/ML |
Questions
Is there a generic for Vi-twel?
Yes. The generic name for Vi-twel is cyanocobalamin. 14 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
What is the generic name for Vi-twel?
The active ingredient in Vi-twel is cyanocobalamin, 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.