FDA Orange Book
Generic for Zantac
Zantac contains ranitidine. 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 Zantac is ranitidine. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 6 of the 13 Zantac products the Orange Book lists.
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Zantac products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | EQ 150MG BASE | Discontinued | None | 2 | AB |
| capsule, oral | EQ 300MG BASE | Discontinued | None | 2 | AB |
| granule, effervescent, oral | EQ 150MG BASE/PACKET | Discontinued | None | 0 | None |
| injectable, injection | EQ 25MG BASE/ML | Discontinued | None | 0 | None |
| syrup, oral | EQ 15MG BASE/ML | Discontinued | None | 0 | None |
| tablet, effervescent, oral | EQ 150MG BASE | Discontinued | None | 0 | None |
| tablet, effervescent, oral | EQ 25MG BASE | Discontinued | None | 0 | None |
| tablet, effervescent, oral | EQ 75MG BASE | Discontinued | None | 0 | None |
| tablet, oral | EQ 150MG BASE | Discontinued | None | 3 | AB |
| tablet, oral | EQ 150MG BASE | Discontinued | None | 3 | AB |
| tablet, oral | EQ 150MG BASE | Discontinued | None | 3 | AB |
| tablet, oral | EQ 300MG BASE | Discontinued | None | 3 | AB |
| tablet, oral | EQ 75MG BASE | Discontinued | None | 0 | None |
NDA 020095, 020251, 019090, 019675, 020745, 021698, 018703, 020520, held by GLAXOSMITHKLINE. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic ranitidine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| SANDOZ INC | 074467 | AB (A-rated, therapeutically equivalent) | August 29, 1997 | EQ 150MG BASE, EQ 150MG BASE, EQ 150MG BASE, EQ 300MG BASE |
| SANDOZ INC | 074655 | AB (A-rated, therapeutically equivalent) | October 22, 1997 | EQ 150MG BASE, EQ 300MG BASE |
| DR REDDYS LABORATORIES LTD | 075742 | AB (A-rated, therapeutically equivalent) | November 29, 2000 | EQ 150MG BASE, EQ 300MG BASE |
| DR REDDYS LABORATORIES INC | 076705 | AB (A-rated, therapeutically equivalent) | July 27, 2005 | EQ 150MG BASE, EQ 150MG BASE, EQ 150MG BASE, EQ 300MG BASE |
| VKT PHARMA PRIVATE LTD | 211289 | AB (A-rated, therapeutically equivalent) | January 31, 2019 | EQ 150MG BASE, EQ 150MG BASE, EQ 150MG BASE, EQ 300MG BASE |
Questions
Is there a generic for Zantac?
Yes. The generic name for Zantac is ranitidine. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 6 of the 13 Zantac products the Orange Book lists.
What is the generic name for Zantac?
The active ingredient in Zantac is ranitidine, 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.