Acyclovir
- Product NDC
- 71335-1077
- Requested package NDC
- 71335-1077-9
- 11-digit product format
- 713351077
- Labeler code
- 71335
- Product ID
- 71335-1077_1e1ab04a-ed67-4b12-a671-92b86ac9153e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Acyclovir
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA210401
- Marketing category
- ANDA
- Marketing start
- 2018-05-04
- Marketing end
- 0000-00-00
- Substance
- ACYCLOVIR
- Active strength
- 400 mg/1
- Pharmacologic classes
- DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 71335-1077 | 71335-1077-9 | D | Discontinued by firm | 2026-08-10 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A210401-001 | ACYCLOVIR | ACYCLOVIR | 400MG | TABLET / ORAL | AB | 2018-03-07 | |
| A210401-002 | ACYCLOVIR | ACYCLOVIR | 800MG | TABLET / ORAL | AB | 2018-03-07 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A210401-001 | AB |
| A210401-002 | AB |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A210401-001 | ACYCLOVIR | 400MG | TABLET / ORAL | AB | 2018-03-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A210401-002 | ACYCLOVIR | 800MG | TABLET / ORAL | AB | 2018-03-07 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210401-001 | ACYCLOVIR | 400MG | TABLET / ORAL | AB | 2018-03-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210401-002 | ACYCLOVIR | 800MG | TABLET / ORAL | AB | 2018-03-07 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A210401-001 | ACYCLOVIR | 400MG | TABLET / ORAL | AB | 2018-03-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A210401-002 | ACYCLOVIR | 800MG | TABLET / ORAL | AB | 2018-03-07 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210401-001 | ACYCLOVIR | 400MG | TABLET / ORAL | AB | 2018-03-07 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210401-002 | ACYCLOVIR | 800MG | TABLET / ORAL | AB | 2018-03-07 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210401-001 | ACYCLOVIR | 400MG | TABLET / ORAL | AB | 2018-03-07 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210401-002 | ACYCLOVIR | 800MG | TABLET / ORAL | AB | 2018-03-07 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210401-001 | ACYCLOVIR | 400MG | TABLET / ORAL | AB | 2018-03-07 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210401-002 | ACYCLOVIR | 800MG | TABLET / ORAL | AB | 2018-03-07 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210401-001 | ACYCLOVIR | 400MG | TABLET / ORAL | AB | 2018-03-07 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210401-002 | ACYCLOVIR | 800MG | TABLET / ORAL | AB | 2018-03-07 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210401-001 | ACYCLOVIR | 400MG | TABLET / ORAL | AB | 2018-03-07 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210401-002 | ACYCLOVIR | 800MG | TABLET / ORAL | AB | 2018-03-07 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210401-001 | ACYCLOVIR | 400MG | TABLET / ORAL | AB | 2018-03-07 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210401-002 | ACYCLOVIR | 800MG | TABLET / ORAL | AB | 2018-03-07 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A210401-001 | ACYCLOVIR | 400MG | TABLET / ORAL | AB | 2018-03-07 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A210401-002 | ACYCLOVIR | 800MG | TABLET / ORAL | AB | 2018-03-07 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210401-001 | ACYCLOVIR | 400MG | TABLET / ORAL | AB | 2018-03-07 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210401-002 | ACYCLOVIR | 800MG | TABLET / ORAL | AB | 2018-03-07 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210401-001 | ACYCLOVIR | 400MG | TABLET / ORAL | AB | 2018-03-07 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210401-002 | ACYCLOVIR | 800MG | TABLET / ORAL | AB | 2018-03-07 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210401-001 | ACYCLOVIR | 400MG | TABLET / ORAL | AB | 2018-03-07 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210401-002 | ACYCLOVIR | 800MG | TABLET / ORAL | AB | 2018-03-07 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A210401-001 | ACYCLOVIR | 400MG | TABLET / ORAL | AB | 2018-03-07 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A210401-002 | ACYCLOVIR | 800MG | TABLET / ORAL | AB | 2018-03-07 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A210401-001 | ACYCLOVIR | 400MG | TABLET / ORAL | AB | 2018-03-07 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A210401-002 | ACYCLOVIR | 800MG | TABLET / ORAL | AB | 2018-03-07 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A210401-001 | ACYCLOVIR | 400MG | TABLET / ORAL | AB | 2018-03-07 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A210401-002 | ACYCLOVIR | 800MG | TABLET / ORAL | AB | 2018-03-07 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A210401-001 | ACYCLOVIR | 400MG | TABLET / ORAL | AB | 2018-03-07 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A210401-002 | ACYCLOVIR | 800MG | TABLET / ORAL | AB | 2018-03-07 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A210401-001 | ACYCLOVIR | 400MG | TABLET / ORAL | AB | 2018-03-07 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A210401-002 | ACYCLOVIR | 800MG | TABLET / ORAL | AB | 2018-03-07 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A210401-001 | ACYCLOVIR | 400MG | TABLET / ORAL | AB | 2018-03-07 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A210401-002 | ACYCLOVIR | 800MG | TABLET / ORAL | AB | 2018-03-07 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A210401-001 | ACYCLOVIR | 400MG | TABLET / ORAL | AB | 2018-03-07 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | A210401-002 | ACYCLOVIR | 800MG | TABLET / ORAL | AB | 2018-03-07 | 782e0a99824c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A210401-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A210401-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210401-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210401-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A210401-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A210401-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210401-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210401-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210401-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210401-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210401-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210401-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210401-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210401-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210401-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210401-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210401-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210401-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A210401-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A210401-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210401-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210401-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210401-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210401-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210401-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210401-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A210401-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A210401-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A210401-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A210401-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A210401-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A210401-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A210401-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A210401-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A210401-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A210401-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A210401-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A210401-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A210401-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A210401-002 | AB | 1 | 782e0a99824c… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Acyclovir | ACYCLOVIR | Redpharm Drug | 53cbca4d-3ddc-b11e-e063-6394a90a04fa | 2026-06-09 | Warnings, Adverse reactions | 210401 ANDA210401 |
| Acyclovir | ACYCLOVIR | Westminster Pharmaceuticals, LLC | f352a641-988e-4878-8016-2b69cd6ee548 | 2026-05-11 | Warnings, Adverse reactions | 210401 ANDA210401 |
| Acyclovir | ACYCLOVIR | Bryant Ranch Prepack | 69e5455e-d0be-4c2b-b9ab-458b5480ed57 | 2026-03-16 | Warnings, Adverse reactions | 210401 ANDA210401 |
| Acyclovir | ACYCLOVIR | A-S Medication Solutions | 2e6a3667-af06-40de-80c0-8c4346e0671f | 2026-02-08 | Warnings, Adverse reactions | 210401 ANDA210401 |
| Acyclovir | ACYCLOVIR | Preferred Pharmaceuticals Inc | 75334fc5-d236-401a-875c-f4f9c7749c1a | 2026-01-19 | Warnings, Adverse reactions | 210401 ANDA210401 |
| Acyclovir | ACYCLOVIR | YILING PHARMACEUTICAL, INC. | 67e7b340-0635-2595-e053-2a91aa0ad266 | 2025-12-30 | Warnings, Adverse reactions | 210401 ANDA210401 |
| Acyclovir | ACYCLOVIR | YILING PHARMACEUTICAL, INC. | 677edfd5-2d04-b932-e053-2a91aa0a26b0 | 2025-12-30 | Warnings, Adverse reactions | 210401 ANDA210401 |
| Acyclovir | ACYCLOVIR | Redpharm Drug | 37453bcd-e34e-5902-e063-6294a90a0245 | 2025-12-13 | Warnings, Adverse reactions | 210401 ANDA210401 |
| Acyclovir | ACYCLOVIR | Chartwell RX, LLC | 8cd22728-34b4-4e55-8339-580138fe46d8 | 2025-12-09 | Warnings, Adverse reactions | 210401 ANDA210401 |
| Acyclovir | ACYCLOVIR | Proficient Rx LP | d0908b3c-f5dd-4113-9080-bb01abe13c9c | 2025-07-01 | Warnings, Adverse reactions | 210401 ANDA210401 |
| Acyclovir | ACYCLOVIR | Bryant Ranch Prepack | 8d171c3d-de39-4f82-bacb-3e8d71b16540 | 2025-01-30 | Warnings, Adverse reactions | 210401 ANDA210401 |
| Acyclovir | ACYCLOVIR | A-S Medication Solutions | b96e44ca-aa54-4a64-89f4-fb5a5932ceae | 2024-10-14 | Warnings, Adverse reactions | 210401 ANDA210401 |
| Acyclovir | ACYCLOVIR | A-S Medication Solutions | c0c29e0f-b6e2-49df-88d1-95b7b625d356 | 2024-10-14 | Warnings, Adverse reactions | 210401 ANDA210401 |
| Acyclovir | ACYCLOVIR | A-S Medication Solutions | 6ea3e3f6-132d-4b15-ac58-336de05201a7 | 2024-10-14 | Warnings, Adverse reactions | 210401 ANDA210401 |
| Acyclovir | ACYCLOVIR | Proficient Rx LP | 290af212-7332-4914-9ef0-65760478fb32 | 2024-10-01 | Warnings, Adverse reactions | 210401 ANDA210401 |
| Acyclovir | ACYCLOVIR | Proficient Rx LP | 97ed8713-4b3e-48a9-92c0-0a98ecf0485c | 2024-01-01 | Warnings, Adverse reactions | 210401 ANDA210401 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 71335-1077-9 | 71335107709 | 40 TABLET in 1 BOTTLE (71335-1077-9) | 40 tablet | 2019-03-19 | 0000-00-00 | No | No | Current |