FDA Orange Book
Generic for Rubivite
Rubivite 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 Rubivite is cyanocobalamin. 14 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP. Generics match 1 of the 5 Rubivite products the Orange Book lists.
Run it in Rivvi
Map Rubivite and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Rubivite products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | 0.03MG/ML | Discontinued | None | 0 | None |
| injectable, injection | 0.05MG/ML | Discontinued | None | 0 | None |
| injectable, injection | 0.12MG/ML | Discontinued | None | 0 | None |
| injectable, injection | 0.1MG/ML | Discontinued | None | 0 | None |
| injectable, injection | 1MG/ML | Discontinued | None | 15 | AP |
NDA 010791, held by BEL MAR LABORATORIES 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 Rubivite?
Yes. The generic name for Rubivite is cyanocobalamin. 14 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP. Generics match 1 of the 5 Rubivite products the Orange Book lists.
What is the generic name for Rubivite?
The active ingredient in Rubivite 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.