Active ingredient
Acyclovir
204 finished FDA listings contain Acyclovir as their only active ingredient; 1 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- ACYCLOVIR, ACYCLOVIR SODIUM
- Dosage forms
- Capsule, Cream, Injection, Powder, Lyophilized, For Solution, Injection, Solution, Ointment, Suspension, Tablet
- Routes
- Cutaneous, Intravenous, Ophthalmic, Oral, Topical
- Manufacturers / labelers
- 71
- Strengths listed
- 1 g/1 · 1000 mg/20ml · 200 mg/1 · 200 mg/5ml · 30 mg/g · 400 mg/1 · 50 mg/g · 50 mg/ml · 500 mg/1 · 500 mg/10ml · 800 mg/1
- Brand names in FDA listings
- Acyclovir Suspension, Avaclyr, Zovirax
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 281
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 018604 | BAUSCH | 1982-03-29 | 2 |
| ANDA 074738 | ACTAVIS MID ATLANTIC | 1997-04-28 | 3 |
| ANDA 074891 | HERITAGE | 1997-10-31 | 10 |
| ANDA 074889 | HERITAGE | 1997-10-31 | 3 |
| ANDA 074930 | FRESENIUS KABI USA | 1998-05-13 | 2 |
| ANDA 075211 | AUROBINDO PHARMA USA | 1998-09-28 | 2 |
| ANDA 075090 | REGCON HOLDINGS | 1999-01-26 | 6 |
| ANDA 075382 | CARLSBAD | 1999-04-30 | 16 |
| NDA 021478 | BAUSCH | 2002-12-30 | 2 |
| ANDA 075677 | APOTEX | 2005-09-28 | 4 |
| ANDA 077309 | APOTEX | 2005-09-29 | 12 |
| ANDA 202459 | PHARMOBEDIENT | 2013-04-03 | 1 |
| ANDA 203701 | EUGIA PHARMA | 2013-10-11 | 5 |
| ANDA 203834 | HETERO LABS LTD V | 2013-10-29 | 23 |
| ANDA 202168 | CADILA PHARMS LTD | 2013-11-15 | 4 |
| ANDA 201445 | CADILA PHARMS LTD | 2014-03-06 | 2 |
| ANDA 204605 | AMNEAL PHARMS | 2014-06-18 | 1 |
| ANDA 204314 | ZYDUS PHARMS | 2014-08-19 | 12 |
| ANDA 205771 | HIKMA | 2016-02-29 | 2 |
| ANDA 204313 | CADILA | 2016-03-25 | 9 |
| ANDA 205510 | GLENMARK SPECLT | 2017-07-31 | 4 |
| ANDA 206261 | CARLSBAD | 2017-08-16 | 6 |
| ANDA 210401 | YILING | 2018-03-07 | 18 |
| ANDA 206535 | ZYDUS PHARMS | 2018-08-31 | 4 |
| ANDA 209971 | TORRENT | 2019-01-11 | 2 |
| ANDA 208702 | PADAGIS ISRAEL | 2019-02-04 | 2 |
| ANDA 205974 | ZYDUS LIFESCIENCES | 2019-03-15 | 5 |
| NDA 202408 | FERA PHARMS LLC | 2019-03-29 | 1 |
| ANDA 209366 | ADAPTIS | 2019-10-07 | 14 |
| ANDA 201501 | XIROMED | 2020-01-29 | 4 |
| ANDA 212718 | CHARTWELL RX | 2020-04-23 | 2 |
| ANDA 212252 | NOVITIUM PHARMA | 2020-07-10 | 1 |
| ANDA 212173 | YILING | 2020-09-14 | 3 |
| ANDA 212444 | MACLEODS PHARMS | 2021-05-19 | 1 |
| ANDA 212202 | PRINSTON INC | 2021-11-15 | 1 |
| ANDA 215724 | RUBICON RESEARCH | 2022-08-18 | 1 |
| ANDA 206770 | ZYDUS LIFESCIENCES | 2023-02-28 | 2 |
| ANDA 217393 | MSN | 2023-03-09 | 2 |
| ANDA 212361 | ALEMBIC | 2023-11-21 | 1 |
| ANDA 215404 | FRESENIUS KABI USA | 2024-06-25 | 2 |
Showing 40 of 47 applications.
Official labeling on DailyMed
- ACYCLOVIR TABLET [AMERICAN HEALTH PACKAGING] · version 6 · 2026-09-07
- ACYCLOVIR TABLET [NORTHWIND HEALTH COMPANY, LLC] · version 2 · 2026-09-07
- ACYCLOVIR OINTMENT [TORRENT PHARMACEUTICALS LIMITED] · version 10 · 2026-09-02
- ACYCLOVIR TABLET [REMEDYREPACK INC.] · version 3 · 2026-09-02
- ACYCLOVIR TABLET [NUCARE PHARMACEUTICALS, INC.] · version 6 · 2026-08-31
- ACYCLOVIR TABLET [NUCARE PHARMACEUTICALS,INC.] · version 5 · 2026-08-28
- ACYCLOVIR CAPSULE [CARDINAL HEALTH 107, LLC] · version 2 · 2026-08-25
- ACYCLOVIR TABLET [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.] · version 6 · 2026-08-24
- ACYCLOVIR TABLET [PD-RX PHARMACEUTICALS, INC.] · version 8 · 2026-08-20
- ACYCLOVIR OINTMENT [C] · version 1 · 2026-08-14
- ACYCLOVIR TABLET [REMEDYREPACK INC.] · version 16 · 2026-07-27
- ACYCLOVIR TABLET [REMEDYREPACK INC.] · version 12 · 2026-07-27
Showing the 12 most recent of 177 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.