FDA Orange Book
Generic for Razadyne
Razadyne contains galantamine. 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 Razadyne is galantamine. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Razadyne products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, oral | 4MG/ML | Discontinued | None | 1 | None |
| tablet, oral | EQ 12MG BASE | Discontinued | None | 6 | AB |
| tablet, oral | EQ 4MG BASE | Discontinued | None | 6 | AB |
| tablet, oral | EQ 8MG BASE | Discontinued | None | 6 | AB |
NDA 021224, 021169, held by JANSSEN PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic galantamine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| BARR LABORATORIES INC | 077605 | AB (A-rated, therapeutically equivalent) | August 28, 2008 | EQ 12MG BASE, EQ 4MG BASE, EQ 8MG BASE |
| PHARMAZONE | 077593 | AB (A-rated, therapeutically equivalent) | September 11, 2008 | EQ 12MG BASE, EQ 4MG BASE, EQ 8MG BASE |
| HIKMA PHARMACEUTICALS USA INC | 078185 | None (No TE code listed) | January 30, 2009 | 4MG/ML |
| YABAO PHARMACEUTICAL CO LTD BEIJING | 077604 | AB (A-rated, therapeutically equivalent) | February 6, 2009 | EQ 12MG BASE, EQ 4MG BASE, EQ 8MG BASE |
| SANDOZ INC | 077589 | AB (A-rated, therapeutically equivalent) | June 22, 2009 | EQ 12MG BASE, EQ 4MG BASE, EQ 8MG BASE |
| ZYDUS PHARMACEUTICALS USA INC | 078898 | AB (A-rated, therapeutically equivalent) | February 17, 2011 | EQ 12MG BASE, EQ 4MG BASE, EQ 8MG BASE |
| AUROBINDO PHARMA LIMITED | 090957 | AB (A-rated, therapeutically equivalent) | March 29, 2011 | EQ 12MG BASE, EQ 4MG BASE, EQ 8MG BASE |
Questions
Is there a generic for Razadyne?
Yes. The generic name for Razadyne is galantamine. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Razadyne?
The active ingredient in Razadyne is galantamine, 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.