FDA Orange Book
Generic for Vibramycin
Vibramycin contains doxycycline. 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 Vibramycin is doxycycline. 24 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AP. Generics match 5 of the 6 Vibramycin products the Orange Book lists.
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Vibramycin products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | EQ 100MG BASE | Discontinued | None | 10 | AB |
| capsule, oral | EQ 50MG BASE | Discontinued | None | 7 | AB |
| for suspension, oral | EQ 25MG BASE/5ML | Discontinued | None | 2 | AB |
| injectable, injection | EQ 100MG BASE/VIAL | Discontinued | None | 14 | AP |
| injectable, injection | EQ 200MG BASE/VIAL | Discontinued | None | 4 | AP |
| suspension, oral | EQ 50MG BASE/5ML | Discontinued | None | 0 | None |
NDA 050007, 050006, 050442, 050480, held by PFIZER LABORATORIES DIV PFIZER INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic doxycycline
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| STRIDES PHARMA GLOBAL PTE LTD | 062337 | AB (A-rated, therapeutically equivalent) | March 29, 1982 | EQ 100MG BASE, EQ 50MG BASE |
| FRESENIUS KABI USA LLC | 062475 | AP (A-rated, therapeutically equivalent) | December 9, 1983 | EQ 100MG BASE/VIAL, EQ 200MG BASE/VIAL |
| HIKMA PHARMACEUTICALS USA INC | 062396 | AB (A-rated, therapeutically equivalent) | May 7, 1984 | EQ 100MG BASE, EQ 50MG BASE |
| CHARTWELL SCHEDULED LLC | 062500 | AB (A-rated, therapeutically equivalent) | September 11, 1984 | EQ 100MG BASE, EQ 50MG BASE |
| SUN PHARMACEUTICAL INDUSTRIES INC | 062676 | AB (A-rated, therapeutically equivalent) | July 10, 1986 | EQ 100MG BASE, EQ 50MG BASE |
| WEST-WARD PHARMACEUTICALS INTERNATIONAL LTD | 062992 | AP (A-rated, therapeutically equivalent) | February 16, 1989 | EQ 100MG BASE/VIAL, EQ 200MG BASE/VIAL |
| CHARTWELL SCHEDULED LLC | 065454 | AB (A-rated, therapeutically equivalent) | July 16, 2008 | EQ 25MG BASE/5ML |
| MYLAN LABORATORIES LTD | 091406 | AP (A-rated, therapeutically equivalent) | August 21, 2012 | EQ 100MG BASE/VIAL |
| LUPIN LTD | 201678 | AB (A-rated, therapeutically equivalent) | March 18, 2013 | EQ 25MG BASE/5ML |
| AMNEAL PHARMACEUTICALS HOLDINGS GMBH | 207289 | AB (A-rated, therapeutically equivalent) | June 27, 2016 | EQ 100MG BASE |
| ZYDUS PHARMACEUTICALS USA INC | 207757 | AP (A-rated, therapeutically equivalent) | September 28, 2017 | EQ 100MG BASE/VIAL, EQ 200MG BASE/VIAL |
| ZYDUS LIFESCIENCES LTD | 207774 | AB (A-rated, therapeutically equivalent) | May 31, 2018 | EQ 100MG BASE, EQ 50MG BASE |
| ALEMBIC PHARMACEUTICALS LTD | 210527 | AB (A-rated, therapeutically equivalent) | June 13, 2018 | EQ 100MG BASE, EQ 50MG BASE |
| CHANGZHOU PHARMACEUTICAL FACTORY | 209402 | AB (A-rated, therapeutically equivalent) | October 7, 2019 | EQ 100MG BASE |
| PH HEALTH LTD | 216690 | AP (A-rated, therapeutically equivalent) | December 7, 2022 | EQ 100MG BASE/VIAL |
| GLAND PHARMA LTD | 215583 | AP (A-rated, therapeutically equivalent) | April 12, 2023 | EQ 100MG BASE/VIAL |
| LUPIN LTD | 217794 | AP (A-rated, therapeutically equivalent) | March 14, 2024 | EQ 100MG BASE/VIAL |
| HAINAN POLY PHARM CO LTD | 217685 | AP (A-rated, therapeutically equivalent) | June 21, 2024 | EQ 100MG BASE/VIAL, EQ 200MG BASE/VIAL |
| HERITAGE PHARMACEUTICALS INC DBA AVET PHARMACEUTICALS INC | 217854 | AP (A-rated, therapeutically equivalent) | July 23, 2024 | EQ 100MG BASE/VIAL |
| KINDOS PHARMACEUTICALS CO LTD | 218053 | AP (A-rated, therapeutically equivalent) | October 28, 2024 | EQ 100MG BASE/VIAL |
| PHARMOBEDIENT CONSULTING LLC | 217078 | AP (A-rated, therapeutically equivalent) | February 21, 2025 | EQ 100MG BASE/VIAL |
| DR REDDYS LABORATORIES LTD | 218753 | AP (A-rated, therapeutically equivalent) | July 1, 2025 | EQ 100MG BASE/VIAL |
| ASPIRO PHARMA LTD | 218888 | AP (A-rated, therapeutically equivalent) | August 5, 2025 | EQ 100MG BASE/VIAL |
| STERISCIENCE PTE LTD | 217972 | AP (A-rated, therapeutically equivalent) | November 6, 2025 | EQ 100MG BASE/VIAL |
| MACLEODS PHARMACEUTICALS LTD | 211137 | AB (A-rated, therapeutically equivalent) | December 9, 2025 | EQ 100MG BASE |
| ACTAVIS LABORATORIES FL INC | 062031 | AB (A-rated, therapeutically equivalent) | Approved Prior to Jan 1, 1982 | EQ 100MG BASE, EQ 50MG BASE |
Questions
Is there a generic for Vibramycin?
Yes. The generic name for Vibramycin is doxycycline. 24 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AP. Generics match 5 of the 6 Vibramycin products the Orange Book lists.
What is the generic name for Vibramycin?
The active ingredient in Vibramycin is doxycycline, 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.