ACYCLOVIR
- Product NDC
- 23155-227
- 11-digit product format
- 231550227
- Labeler code
- 23155
- Product ID
- 23155-227_6e0a075f-822f-457d-8ccc-e63a16746d76
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ACYCLOVIR
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
- Application
- ANDA074891
- Marketing category
- ANDA
- Marketing start
- 2013-08-08
- 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
- 2026-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A074891-001 | ACYCLOVIR | ACYCLOVIR | 400MG | TABLET / ORAL | AB | 1997-10-31 | |
| A074891-002 | ACYCLOVIR | ACYCLOVIR | 800MG | TABLET / ORAL | AB | 1997-10-31 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A074891-001 | AB |
| A074891-002 | 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 | A074891-001 | ACYCLOVIR | 400MG | TABLET / ORAL | AB | 1997-10-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A074891-002 | ACYCLOVIR | 800MG | TABLET / ORAL | AB | 1997-10-31 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074891-001 | ACYCLOVIR | 400MG | TABLET / ORAL | AB | 1997-10-31 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074891-002 | ACYCLOVIR | 800MG | TABLET / ORAL | AB | 1997-10-31 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A074891-001 | ACYCLOVIR | 400MG | TABLET / ORAL | AB | 1997-10-31 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A074891-002 | ACYCLOVIR | 800MG | TABLET / ORAL | AB | 1997-10-31 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074891-001 | ACYCLOVIR | 400MG | TABLET / ORAL | AB | 1997-10-31 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074891-002 | ACYCLOVIR | 800MG | TABLET / ORAL | AB | 1997-10-31 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074891-001 | ACYCLOVIR | 400MG | TABLET / ORAL | AB | 1997-10-31 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074891-002 | ACYCLOVIR | 800MG | TABLET / ORAL | AB | 1997-10-31 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074891-001 | ACYCLOVIR | 400MG | TABLET / ORAL | AB | 1997-10-31 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074891-002 | ACYCLOVIR | 800MG | TABLET / ORAL | AB | 1997-10-31 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074891-001 | ACYCLOVIR | 400MG | TABLET / ORAL | AB | 1997-10-31 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074891-002 | ACYCLOVIR | 800MG | TABLET / ORAL | AB | 1997-10-31 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074891-001 | ACYCLOVIR | 400MG | TABLET / ORAL | AB | 1997-10-31 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074891-002 | ACYCLOVIR | 800MG | TABLET / ORAL | AB | 1997-10-31 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A074891-001 | ACYCLOVIR | 400MG | TABLET / ORAL | AB | 1997-10-31 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A074891-002 | ACYCLOVIR | 800MG | TABLET / ORAL | AB | 1997-10-31 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A074891-001 | ACYCLOVIR | 400MG | TABLET / ORAL | AB | 1997-10-31 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A074891-002 | ACYCLOVIR | 800MG | TABLET / ORAL | AB | 1997-10-31 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A074891-001 | ACYCLOVIR | 400MG | TABLET / ORAL | AB | 1997-10-31 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A074891-002 | ACYCLOVIR | 800MG | TABLET / ORAL | AB | 1997-10-31 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A074891-001 | ACYCLOVIR | 400MG | TABLET / ORAL | AB | 1997-10-31 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A074891-002 | ACYCLOVIR | 800MG | TABLET / ORAL | AB | 1997-10-31 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A074891-001 | ACYCLOVIR | 400MG | TABLET / ORAL | AB | 1997-10-31 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A074891-002 | ACYCLOVIR | 800MG | TABLET / ORAL | AB | 1997-10-31 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A074891-001 | ACYCLOVIR | 400MG | TABLET / ORAL | AB | 1997-10-31 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A074891-002 | ACYCLOVIR | 800MG | TABLET / ORAL | AB | 1997-10-31 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A074891-001 | ACYCLOVIR | 400MG | TABLET / ORAL | AB | 1997-10-31 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A074891-002 | ACYCLOVIR | 800MG | TABLET / ORAL | AB | 1997-10-31 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A074891-001 | ACYCLOVIR | 400MG | TABLET / ORAL | AB | 1997-10-31 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A074891-002 | ACYCLOVIR | 800MG | TABLET / ORAL | AB | 1997-10-31 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A074891-001 | ACYCLOVIR | 400MG | TABLET / ORAL | AB | 1997-10-31 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A074891-002 | ACYCLOVIR | 800MG | TABLET / ORAL | AB | 1997-10-31 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A074891-001 | ACYCLOVIR | 400MG | TABLET / ORAL | AB | 1997-10-31 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A074891-002 | ACYCLOVIR | 800MG | TABLET / ORAL | AB | 1997-10-31 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A074891-001 | ACYCLOVIR | 400MG | TABLET / ORAL | AB | 1997-10-31 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A074891-002 | ACYCLOVIR | 800MG | TABLET / ORAL | AB | 1997-10-31 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A074891-001 | ACYCLOVIR | 400MG | TABLET / ORAL | AB | 1997-10-31 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | A074891-002 | ACYCLOVIR | 800MG | TABLET / ORAL | AB | 1997-10-31 | 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 | A074891-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A074891-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074891-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074891-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A074891-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A074891-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074891-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074891-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074891-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074891-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074891-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074891-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074891-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074891-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074891-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074891-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A074891-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A074891-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A074891-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A074891-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A074891-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A074891-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A074891-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A074891-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A074891-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A074891-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A074891-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A074891-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A074891-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A074891-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A074891-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A074891-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A074891-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A074891-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A074891-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A074891-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A074891-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A074891-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A074891-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A074891-002 | AB | 1 | 782e0a99824c… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ACYCLOVIR
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACYCLOVIR | 400 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| X4HES1O11F | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 0de2f5c7-9e75-4bdf-9c28-e026cc6694b4 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 33190c02-82e1-0a4d-d716-9ccd23588463 | Product name | 5 | 20250225 |
| c367d1da-5a72-8966-6d11-1eb9a73ae758 | Product name | 3 | 20231115 |
| 5518bf13-db2f-2e9c-3679-e70ecf03752c | Product name | 9 | 20210614 |
| 27897900-0e40-497b-97e1-88057e68fe6c | Product name | 4 | 20200710 |
| ca834e59-e669-229c-9288-0ccb76dc373e | Product name | 9 | 20200220 |
| d7f95c49-d3e1-4bbc-a389-e9cd73f59a28 | Product name | 1 | 20190702 |
| fb15b394-3715-4c87-a447-421489aa8739 | Product name | 3 | 20170727 |
| 7bdc4804-3832-c0df-e519-72b6d47c9792 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 23155-227-01 | ACYCLOVIR | 100 in 1 BOTTLE | TABLET | 100 | 5 | |
| 23155-227-05 | ACYCLOVIR | 500 in 1 BOTTLE | TABLET | 500 | 5 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 23155-227-01 | EA - Each | 23155-227 | ae1224bf-817b-426e-ae90-18891462db1b | 1 | 2013-11-04 |
| 23155-227-05 | EA - Each | 23155-227 | a5c8999b-2645-4747-a839-bd9d41246cf0 | 1 | 2013-11-04 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| ACYCLOVIR | ACTIVE INGREDIENT | X4HES1O11F | ACYCLOVIR TABLET [HERITAGE PHARMACEUTICALS INC.] | 1 | |
| ACYCLOVIR | ACTIVE MOIETY | X4HES1O11F | ACYCLOVIR TABLET [HERITAGE PHARMACEUTICALS INC.] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ACYCLOVIR TABLET [HERITAGE PHARMACEUTICALS INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ACYCLOVIR TABLET [HERITAGE PHARMACEUTICALS INC.] | 1 | |
| POVIDONE K25 | INACTIVE INGREDIENT | K0KQV10C35 | ACYCLOVIR TABLET [HERITAGE PHARMACEUTICALS INC.] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | ACYCLOVIR TABLET [HERITAGE PHARMACEUTICALS INC.] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | ACYCLOVIR TABLET [HERITAGE PHARMACEUTICALS INC.] | 1 |
DailyMed Dashboard NDC Coverage#
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 | American Health Packaging | 05f42300-2a06-45f1-a9b9-6e5c84ae58ec | 2026-02-04 | Warnings, Adverse reactions | 074891 ANDA074891 |
| ACYCLOVIR | ACYCLOVIR | REMEDYREPACK INC. | c1744e01-0e40-4851-8ffc-c3bf29dd7c2b | 2025-09-29 | Warnings, Adverse reactions | 074891 ANDA074891 |
| ACYCLOVIR | ACYCLOVIR | NuCare Pharmaceuticals,Inc. | b1b999a9-11cc-d6e5-e053-2995a90a5478 | 2024-07-17 | Warnings, Adverse reactions | 074891 ANDA074891 |
| ACYCLOVIR | ACYCLOVIR | Bryant Ranch Prepack | 331fe0bd-6bb2-4337-8faa-d0c82ff54dc7 | 2024-05-24 | Warnings, Adverse reactions | 074891 ANDA074891 |
| ACYCLOVIR | ACYCLOVIR | Bryant Ranch Prepack | c0e41bf9-e141-404e-9952-aeeb705958b4 | 2024-04-05 | Warnings, Adverse reactions | 074891 ANDA074891 |
| ACYCLOVIR | ACYCLOVIR | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 0de2f5c7-9e75-4bdf-9c28-e026cc6694b4 | 2023-07-26 | Warnings, Adverse reactions | 074891 ANDA074891 23155-227 |
| ACYCLOVIR | ACYCLOVIR | Proficient Rx LP | 32aa3f42-23a1-4867-8228-e6e76cf9f135 | 2022-02-01 | Warnings, Adverse reactions | 074891 ANDA074891 |
DailyMed RxNorm Mappings#
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 23155-227-01 | 23155022701 | 100 TABLET in 1 BOTTLE (23155-227-01) | 100 tablet | 2013-08-08 | 0000-00-00 | No | No | Current |
| 23155-227-05 | 23155022705 | 500 TABLET in 1 BOTTLE (23155-227-05) | 500 tablet | 2013-08-08 | 0000-00-00 | No | No | Current |