FDA Orange Book
Generic for Nascobal
Nascobal 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 Nascobal is cyanocobalamin. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 1 of the 2 Nascobal products the Orange Book lists.
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Nascobal products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| gel, metered, nasal | 0.5MG/INH | Discontinued | None | 0 | None |
| spray, metered, nasal | 0.5MG/SPRAY | Discontinued | None | 2 | AB |
NDA 019722, 021642, held by ENDO OPERATIONS LTD. 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 |
|---|---|---|---|---|
| PADAGIS ISRAEL PHARMACEUTICALS LTD | 212458 | AB (A-rated, therapeutically equivalent) | September 9, 2020 | 0.5MG/SPRAY |
| LUPIN INC | 210629 | AB (A-rated, therapeutically equivalent) | June 30, 2023 | 0.5MG/SPRAY |
Nascobal NDC codes
Questions
Is there a generic for Nascobal?
Yes. The generic name for Nascobal is cyanocobalamin. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 1 of the 2 Nascobal products the Orange Book lists.
What is the generic name for Nascobal?
The active ingredient in Nascobal 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.