FDA Orange Book
Generic for Zovirax
Zovirax contains acyclovir. 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 Zovirax is acyclovir. 30 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, BX. Generics match 6 of the 9 Zovirax products the Orange Book lists.
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Zovirax products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 200MG | Discontinued | None | 8 | AB |
| cream, topical | 5% | Marketed (Rx) | AB | 5 | AB, BX |
| injectable, injection | EQ 1GM BASE/VIAL | Discontinued | None | 0 | None |
| injectable, injection | EQ 250MG BASE/VIAL | Discontinued | None | 0 | None |
| injectable, injection | EQ 500MG BASE/VIAL | Discontinued | None | 0 | None |
| ointment, topical | 5% | Marketed (Rx) | AB | 11 | AB |
| suspension, oral | 200MG/5ML | Discontinued | None | 7 | AB |
| tablet, oral | 400MG | Discontinued | None | 10 | AB |
| tablet, oral | 800MG | Discontinued | None | 10 | AB |
NDA 018828, 021478, 018603, 018604, 019909, 020089, held by PHARMOBEDIENT CONSULTING LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic acyclovir
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| TEVA PHARMACEUTICALS USA INC | 074578 | AB (A-rated, therapeutically equivalent) | April 22, 1997 | 200MG |
| TEVA PHARMACEUTICALS USA INC | 074556 | AB (A-rated, therapeutically equivalent) | April 22, 1997 | 400MG, 800MG |
| ACTAVIS MID ATLANTIC LLC | 074738 | AB (A-rated, therapeutically equivalent) | April 28, 1997 | 200MG/5ML |
| HERITAGE PHARMACEUTICALS INC DBA AVET PHARMACEUTICALS INC | 074889 | AB (A-rated, therapeutically equivalent) | October 31, 1997 | 200MG |
| HERITAGE PHARMACEUTICALS INC DBA AVET PHARMACEUTICALS INC | 074891 | AB (A-rated, therapeutically equivalent) | October 31, 1997 | 400MG, 800MG |
| AUROBINDO PHARMA USA INC | 075211 | AB (A-rated, therapeutically equivalent) | September 28, 1998 | 400MG, 800MG |
| REGCON HOLDINGS LLC | 075090 | AB (A-rated, therapeutically equivalent) | January 26, 1999 | 200MG |
| CARLSBAD TECHNOLOGY INC | 075382 | AB (A-rated, therapeutically equivalent) | April 30, 1999 | 400MG, 800MG |
| APOTEX INC | 075677 | AB (A-rated, therapeutically equivalent) | September 28, 2005 | 200MG |
| APOTEX INC | 077309 | AB (A-rated, therapeutically equivalent) | September 29, 2005 | 400MG, 800MG |
| PHARMOBEDIENT CONSULTING LLC | 202459 | AB (A-rated, therapeutically equivalent) | April 3, 2013 | 5% |
| HETERO LABS LTD UNIT V | 203834 | AB (A-rated, therapeutically equivalent) | October 29, 2013 | 400MG, 800MG |
| CADILA PHARMACEUTICALS LTD | 202168 | AB (A-rated, therapeutically equivalent) | November 15, 2013 | 400MG, 800MG |
| CADILA PHARMACEUTICALS LTD | 201445 | AB (A-rated, therapeutically equivalent) | March 6, 2014 | 200MG |
| AMNEAL PHARMACEUTICALS | 204605 | AB (A-rated, therapeutically equivalent) | June 18, 2014 | 5% |
| ZYDUS PHARMACEUTICALS USA INC | 204314 | AB (A-rated, therapeutically equivalent) | August 19, 2014 | 400MG, 800MG |
| CADILA HEALTHCARE LTD | 204313 | AB (A-rated, therapeutically equivalent) | March 25, 2016 | 200MG |
| FOUGERA PHARMACEUTICALS INC | 206633 | AB (A-rated, therapeutically equivalent) | May 11, 2016 | 5% |
| SUN PHARMA CANADA INC | 205469 | AB (A-rated, therapeutically equivalent) | December 21, 2016 | 5% |
| GLENMARK SPECIALTY SA | 205510 | AB (A-rated, therapeutically equivalent) | July 31, 2017 | 5% |
| CARLSBAD TECHNOLOGY INC | 206261 | AB (A-rated, therapeutically equivalent) | August 16, 2017 | 200MG |
| PHARMOBEDIENT CONSULTING LLC | 210401 | AB (A-rated, therapeutically equivalent) | March 7, 2018 | 400MG, 800MG |
| ALEMBIC PHARMACEUTICALS LTD | 209000 | AB (A-rated, therapeutically equivalent) | April 6, 2018 | 5% |
| TORRENT PHARMACEUTICALS LTD | 209971 | AB (A-rated, therapeutically equivalent) | January 11, 2019 | 5% |
| PADAGIS ISRAEL PHARMACEUTICALS LTD | 208702 | AB (A-rated, therapeutically equivalent) | February 4, 2019 | 5% |
| ZYDUS LIFESCIENCES LTD | 205974 | AB (A-rated, therapeutically equivalent) | March 15, 2019 | 5% |
| ADAPTIS PHARMA PRIVATE LTD | 209366 | AB (A-rated, therapeutically equivalent) | October 7, 2019 | 400MG, 800MG |
| XIROMED PHARMA ESPANA SL | 201501 | AB (A-rated, therapeutically equivalent) | January 29, 2020 | 5% |
| CHARTWELL RX SCIENCES LLC | 212495 | AB (A-rated, therapeutically equivalent) | April 7, 2020 | 5% |
| CHARTWELL RX SCIENCES LLC | 212718 | AB (A-rated, therapeutically equivalent) | April 23, 2020 | 200MG/5ML |
| NOVITIUM PHARMA LLC | 212252 | AB (A-rated, therapeutically equivalent) | July 10, 2020 | 200MG/5ML |
| PHARMOBEDIENT CONSULTING LLC | 212173 | AB (A-rated, therapeutically equivalent) | September 14, 2020 | 200MG |
| AMNEAL PHARMACEUTICALS LLC | 208766 | AB (A-rated, therapeutically equivalent) | November 9, 2020 | 5% |
| MACLEODS PHARMACEUTICALS LTD | 212444 | AB (A-rated, therapeutically equivalent) | May 19, 2021 | 5% |
| AUROBINDO PHARMA LTD | 216331 | AB (A-rated, therapeutically equivalent) | March 31, 2022 | 200MG/5ML |
| HETERO LABS LTD UNIT III | 215669 | AB (A-rated, therapeutically equivalent) | July 1, 2022 | 200MG/5ML |
| RUBICON RESEARCH LTD | 215724 | AB (A-rated, therapeutically equivalent) | August 18, 2022 | 200MG/5ML |
| ZYDUS LIFESCIENCES LTD | 206770 | BX (B-rated, not considered equivalent) | February 28, 2023 | 5% |
| MSN LABORATORIES PRIVATE LTD | 217393 | AB (A-rated, therapeutically equivalent) | March 9, 2023 | 200MG/5ML |
| ALEMBIC PHARMACEUTICALS LTD | 212361 | AB (A-rated, therapeutically equivalent) | November 21, 2023 | 5% |
| SUN PHARMA CANADA INC | 205470 | AB (A-rated, therapeutically equivalent) | June 12, 2024 | 5% |
Zovirax NDC codes
Questions
Is there a generic for Zovirax?
Yes. The generic name for Zovirax is acyclovir. 30 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, BX. Generics match 6 of the 9 Zovirax products the Orange Book lists.
What is the generic name for Zovirax?
The active ingredient in Zovirax is acyclovir, 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.
More on Zovirax and Acyclovir
- What is Acyclovir used for?FDA label uses
- Is Acyclovir a controlled substance?Federal schedule
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- NDC 0187-0993Zovirax NDC record
- NDC 0187-0994Zovirax NDC record