Acyclovir
- Product NDC
- 12634-520
- 11-digit product format
- 126340520
- Labeler code
- 12634
- Product ID
- 12634-520_34f57b50-d012-2c77-e054-00144ff88e88
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Acyclovir
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Apotheca Inc.
- Application
- ANDA074556
- Marketing category
- ANDA
- Marketing start
- 1997-04-23
- 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
- 2019-12-31
- 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 product | product | 12634-520 | I | Inactivated by FDA | 2026-08-10 | ||
| excluded package | package | 12634-520 | 12634-520-00 | I | Inactivated by FDA | 2026-08-10 | |
| excluded package | package | 12634-520 | 12634-520-01 | I | Inactivated by FDA | 2026-08-10 | |
| excluded package | package | 12634-520 | 12634-520-09 | I | Inactivated by FDA | 2026-08-10 | |
| excluded package | package | 12634-520 | 12634-520-40 | I | Inactivated by FDA | 2026-08-10 | |
| excluded package | package | 12634-520 | 12634-520-52 | I | Inactivated by FDA | 2026-08-10 | |
| excluded package | package | 12634-520 | 12634-520-54 | I | Inactivated by FDA | 2026-08-10 | |
| excluded package | package | 12634-520 | 12634-520-57 | I | Inactivated by FDA | 2026-08-10 | |
| excluded package | package | 12634-520 | 12634-520-59 | I | Inactivated by FDA | 2026-08-10 | |
| excluded package | package | 12634-520 | 12634-520-60 | I | Inactivated by FDA | 2026-08-10 | |
| excluded package | package | 12634-520 | 12634-520-61 | I | Inactivated by FDA | 2026-08-10 | |
| excluded package | package | 12634-520 | 12634-520-63 | I | Inactivated by FDA | 2026-08-10 | |
| excluded package | package | 12634-520 | 12634-520-66 | I | Inactivated by FDA | 2026-08-10 | |
| excluded package | package | 12634-520 | 12634-520-67 | I | Inactivated by FDA | 2026-08-10 | |
| excluded package | package | 12634-520 | 12634-520-69 | I | Inactivated by FDA | 2026-08-10 | |
| excluded package | package | 12634-520 | 12634-520-71 | I | Inactivated by FDA | 2026-08-10 | |
| excluded package | package | 12634-520 | 12634-520-74 | I | Inactivated by FDA | 2026-08-10 | |
| excluded package | package | 12634-520 | 12634-520-78 | I | Inactivated by FDA | 2026-08-10 | |
| excluded package | package | 12634-520 | 12634-520-79 | I | Inactivated by FDA | 2026-08-10 | |
| excluded package | package | 12634-520 | 12634-520-80 | I | Inactivated by FDA | 2026-08-10 | |
| excluded package | package | 12634-520 | 12634-520-81 | I | Inactivated by FDA | 2026-08-10 | |
| excluded package | package | 12634-520 | 12634-520-82 | I | Inactivated by FDA | 2026-08-10 | |
| excluded package | package | 12634-520 | 12634-520-85 | I | Inactivated by FDA | 2026-08-10 | |
| excluded package | package | 12634-520 | 12634-520-91 | I | Inactivated by FDA | 2026-08-10 | |
| excluded package | package | 12634-520 | 12634-520-94 | I | Inactivated by FDA | 2026-08-10 | |
| excluded package | package | 12634-520 | 12634-520-95 | I | Inactivated by FDA | 2026-08-10 | |
| excluded package | package | 12634-520 | 12634-520-96 | I | Inactivated by FDA | 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 | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 12634-520-67 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 12634-520-63 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 12634-520-91 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 12634-520-00 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 12634-520-09 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 12634-520-59 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 12634-520-81 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 12634-520-78 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 12634-520-96 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 12634-520-54 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 12634-520-40 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 12634-520-95 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 12634-520-80 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 12634-520-61 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 12634-520-79 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 12634-520-74 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 12634-520-85 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 12634-520-52 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 12634-520-94 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 12634-520-82 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 12634-520-71 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 12634-520-57 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 12634-520-69 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 12634-520-60 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 12634-520-01 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 12634-520-66 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 12634-520-67 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 12634-520-63 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 12634-520-91 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 12634-520-00 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 12634-520-09 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 12634-520-59 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 12634-520-81 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 12634-520-78 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 12634-520-96 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 12634-520-54 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 12634-520-40 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 12634-520-95 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 12634-520-80 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 12634-520-61 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 12634-520-79 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 12634-520-74 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 12634-520-85 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 12634-520-52 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 12634-520-94 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 12634-520-82 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 12634-520-71 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 12634-520-57 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 12634-520-69 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 12634-520-60 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 12634-520-01 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 12634-520-66 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 12634-520-67 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 12634-520-63 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 12634-520-91 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 12634-520-00 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 12634-520-09 | 2ef7874e63bc… | 57b86245f4fa… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A074556-001 | ACYCLOVIR | ACYCLOVIR | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 1997-04-22 | ||
| A074556-002 | ACYCLOVIR | ACYCLOVIR | 400MG | TABLET / ORAL | AB | 1997-04-22 | |
| A074556-003 | ACYCLOVIR | ACYCLOVIR | 800MG | TABLET / ORAL | AB | 1997-04-22 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A074556-002 | AB |
| A074556-003 | 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 | A074556-001 | ACYCLOVIR | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 1997-04-22 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A074556-002 | ACYCLOVIR | 400MG | TABLET / ORAL | AB | 1997-04-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A074556-003 | ACYCLOVIR | 800MG | TABLET / ORAL | AB | 1997-04-22 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074556-001 | ACYCLOVIR | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 1997-04-22 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074556-002 | ACYCLOVIR | 400MG | TABLET / ORAL | AB | 1997-04-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074556-003 | ACYCLOVIR | 800MG | TABLET / ORAL | AB | 1997-04-22 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A074556-001 | ACYCLOVIR | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 1997-04-22 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A074556-002 | ACYCLOVIR | 400MG | TABLET / ORAL | AB | 1997-04-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A074556-003 | ACYCLOVIR | 800MG | TABLET / ORAL | AB | 1997-04-22 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074556-001 | ACYCLOVIR | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 1997-04-22 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074556-002 | ACYCLOVIR | 400MG | TABLET / ORAL | AB | 1997-04-22 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074556-003 | ACYCLOVIR | 800MG | TABLET / ORAL | AB | 1997-04-22 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074556-001 | ACYCLOVIR | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 1997-04-22 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074556-002 | ACYCLOVIR | 400MG | TABLET / ORAL | AB | 1997-04-22 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074556-003 | ACYCLOVIR | 800MG | TABLET / ORAL | AB | 1997-04-22 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074556-001 | ACYCLOVIR | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 1997-04-22 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074556-002 | ACYCLOVIR | 400MG | TABLET / ORAL | AB | 1997-04-22 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074556-003 | ACYCLOVIR | 800MG | TABLET / ORAL | AB | 1997-04-22 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074556-001 | ACYCLOVIR | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 1997-04-22 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074556-002 | ACYCLOVIR | 400MG | TABLET / ORAL | AB | 1997-04-22 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074556-003 | ACYCLOVIR | 800MG | TABLET / ORAL | AB | 1997-04-22 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074556-001 | ACYCLOVIR | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 1997-04-22 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074556-002 | ACYCLOVIR | 400MG | TABLET / ORAL | AB | 1997-04-22 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074556-003 | ACYCLOVIR | 800MG | TABLET / ORAL | AB | 1997-04-22 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A074556-001 | ACYCLOVIR | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 1997-04-22 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A074556-002 | ACYCLOVIR | 400MG | TABLET / ORAL | AB | 1997-04-22 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A074556-003 | ACYCLOVIR | 800MG | TABLET / ORAL | AB | 1997-04-22 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A074556-001 | ACYCLOVIR | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 1997-04-22 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A074556-002 | ACYCLOVIR | 400MG | TABLET / ORAL | AB | 1997-04-22 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A074556-003 | ACYCLOVIR | 800MG | TABLET / ORAL | AB | 1997-04-22 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A074556-001 | ACYCLOVIR | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 1997-04-22 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A074556-002 | ACYCLOVIR | 400MG | TABLET / ORAL | AB | 1997-04-22 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A074556-003 | ACYCLOVIR | 800MG | TABLET / ORAL | AB | 1997-04-22 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A074556-001 | ACYCLOVIR | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 1997-04-22 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A074556-002 | ACYCLOVIR | 400MG | TABLET / ORAL | AB | 1997-04-22 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A074556-003 | ACYCLOVIR | 800MG | TABLET / ORAL | AB | 1997-04-22 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A074556-001 | ACYCLOVIR | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 1997-04-22 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A074556-002 | ACYCLOVIR | 400MG | TABLET / ORAL | AB | 1997-04-22 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A074556-003 | ACYCLOVIR | 800MG | TABLET / ORAL | AB | 1997-04-22 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A074556-001 | ACYCLOVIR | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 1997-04-22 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A074556-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A074556-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074556-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074556-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A074556-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A074556-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074556-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074556-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074556-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074556-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074556-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074556-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074556-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074556-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074556-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074556-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A074556-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A074556-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A074556-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A074556-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A074556-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A074556-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A074556-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A074556-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A074556-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A074556-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A074556-002 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A074556-003 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A074556-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A074556-003 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A074556-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A074556-003 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A074556-002 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A074556-003 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A074556-002 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A074556-003 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A074556-002 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A074556-003 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A074556-002 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A074556-003 | AB | 1 | 782e0a99824c… |
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 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 12634-520-00 | Acyclovir | 10 in 1 BOTTLE | TABLET | 10 | 2 | |
| 12634-520-01 | Acyclovir | 100 in 1 BOTTLE | TABLET | 100 | 2 | |
| 12634-520-09 | Acyclovir | 35 in 1 BOTTLE | TABLET | 35 | 2 | |
| 12634-520-40 | Acyclovir | 40 in 1 BOTTLE | TABLET | 40 | 2 | |
| 12634-520-52 | Acyclovir | 12 in 1 BLISTER PACK | TABLET | 12 | 2 | |
| 12634-520-54 | Acyclovir | 14 in 1 BLISTER PACK | TABLET | 14 | 2 | |
| 12634-520-57 | Acyclovir | 20 in 1 BLISTER PACK | TABLET | 20 | 2 | |
| 12634-520-59 | Acyclovir | 30 in 1 BLISTER PACK | TABLET | 30 | 2 | |
| 12634-520-60 | Acyclovir | 60 in 1 BOTTLE | TABLET | 60 | 2 | |
| 12634-520-61 | Acyclovir | 10 in 1 BLISTER PACK | TABLET | 10 | 2 | |
| 12634-520-63 | Acyclovir | 3 in 1 BLISTER PACK | TABLET | 3 | 2 | |
| 12634-520-66 | Acyclovir | 6 in 1 BLISTER PACK | TABLET | 6 | 2 | |
| 12634-520-67 | Acyclovir | 7 in 1 BLISTER PACK | TABLET | 7 | 2 | |
| 12634-520-69 | Acyclovir | 9 in 1 BLISTER PACK | TABLET | 9 | 2 | |
| 12634-520-71 | Acyclovir | 30 in 1 BOTTLE | TABLET | 30 | 2 | |
| 12634-520-74 | Acyclovir | 24 in 1 BOTTLE | TABLET | 24 | 2 | |
| 12634-520-78 | Acyclovir | 28 in 1 BOTTLE | TABLET | 28 | 2 | |
| 12634-520-79 | Acyclovir | 25 in 1 BOTTLE | TABLET | 25 | 2 | |
| 12634-520-80 | Acyclovir | 20 in 1 BOTTLE | TABLET | 20 | 2 | |
| 12634-520-81 | Acyclovir | 21 in 1 BOTTLE | TABLET | 21 | 2 | |
| 12634-520-82 | Acyclovir | 12 in 1 BOTTLE | TABLET | 12 | 2 | |
| 12634-520-85 | Acyclovir | 15 in 1 BOTTLE | TABLET | 15 | 2 | |
| 12634-520-91 | Acyclovir | 1 in 1 BLISTER PACK | TABLET | 1 | 2 | |
| 12634-520-94 | Acyclovir | 4 in 1 BOTTLE | TABLET | 4 | 2 | |
| 12634-520-95 | Acyclovir | 5 in 1 BOTTLE | TABLET | 5 | 2 | |
| 12634-520-96 | Acyclovir | 6 in 1 BOTTLE | TABLET | 6 | 2 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 197311 | acyclovir 400 MG Oral Tablet | PSN | 34f57b50-d013-2c77-e054-00144ff88e88 | 2 |
| 197311 | acyclovir 400 MG Oral Tablet | SCD | 34f57b50-d013-2c77-e054-00144ff88e88 | 2 |
| 197311 | acycycloguanosine 400 MG Oral Tablet | SY | 34f57b50-d013-2c77-e054-00144ff88e88 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 12634-520-00 | 12634052000 | 10 in 1 BOTTLE | Historical |
| 12634-520-01 | 12634052001 | 100 in 1 BOTTLE | Historical |
| 12634-520-09 | 12634052009 | 35 in 1 BOTTLE | Historical |
| 12634-520-40 | 12634052040 | 40 in 1 BOTTLE | Historical |
| 12634-520-52 | 12634052052 | 12 in 1 BLISTER PACK | Historical |
| 12634-520-54 | 12634052054 | 14 in 1 BLISTER PACK | Historical |
| 12634-520-57 | 12634052057 | 20 in 1 BLISTER PACK | Historical |
| 12634-520-59 | 12634052059 | 30 in 1 BLISTER PACK | Historical |
| 12634-520-60 | 12634052060 | 60 in 1 BOTTLE | Historical |
| 12634-520-61 | 12634052061 | 10 in 1 BLISTER PACK | Historical |
| 12634-520-63 | 12634052063 | 3 in 1 BLISTER PACK | Historical |
| 12634-520-66 | 12634052066 | 6 in 1 BLISTER PACK | Historical |
| 12634-520-67 | 12634052067 | 7 in 1 BLISTER PACK | Historical |
| 12634-520-69 | 12634052069 | 9 in 1 BLISTER PACK | Historical |
| 12634-520-71 | 12634052071 | 30 in 1 BOTTLE | Historical |
| 12634-520-74 | 12634052074 | 24 in 1 BOTTLE | Historical |
| 12634-520-78 | 12634052078 | 28 in 1 BOTTLE | Historical |
| 12634-520-79 | 12634052079 | 25 in 1 BOTTLE | Historical |
| 12634-520-80 | 12634052080 | 20 in 1 BOTTLE | Historical |
| 12634-520-81 | 12634052081 | 21 in 1 BOTTLE | Historical |
| 12634-520-82 | 12634052082 | 12 in 1 BOTTLE | Historical |
| 12634-520-85 | 12634052085 | 15 in 1 BOTTLE | Historical |
| 12634-520-91 | 12634052091 | 1 in 1 BLISTER PACK | Historical |
| 12634-520-94 | 12634052094 | 4 in 1 BOTTLE | Historical |
| 12634-520-95 | 12634052095 | 5 in 1 BOTTLE | Historical |
| 12634-520-96 | 12634052096 | 6 in 1 BOTTLE | Historical |