Hydrocodone Bitartrate and Acetaminophen
- Product NDC
- 52959-737
- 11-digit product format
- 529590737
- Labeler code
- 52959
- Product ID
- 52959-737_76c916a4-b168-2429-e053-2991aa0a52cc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocodone Bitartrate and Acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- H.J Harkins Co., Inc
- Application
- ANDA040736
- Marketing category
- ANDA
- Marketing start
- 2017-12-11
- Marketing end
- 0000-00-00
- Substance
- HYDROCODONE BITARTRATE; ACETAMINOPHEN
- Active strength
- 5 mg/1; mg/1
- Pharmacologic classes
- Opioid Agonist [EPC],Opioid Agonists [MoA]
- DEA schedule
- CII
- 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 | 52959-737 | I | Inactivated by FDA | 2026-09-09 | ||
| excluded product | product | 52959-737 | I | Inactivated by FDA | 2026-09-09 | ||
| excluded product | product | 52959-737 | I | Inactivated by FDA | 2026-09-09 | ||
| excluded package | package | 52959-737 | 52959-737-12 | I | Inactivated by FDA | 2026-09-09 | |
| excluded package | package | 52959-737 | 52959-737-02 | I | Inactivated by FDA | 2026-09-09 | |
| excluded package | package | 52959-737 | 52959-737-15 | I | Inactivated by FDA | 2026-09-09 | |
| excluded package | package | 52959-737 | 52959-737-20 | I | Inactivated by FDA | 2026-09-09 | |
| excluded package | package | 52959-737 | 52959-737-25 | I | Inactivated by FDA | 2026-09-09 | |
| excluded package | package | 52959-737 | 52959-737-28 | I | Inactivated by FDA | 2026-09-09 | |
| excluded package | package | 52959-737 | 52959-737-30 | I | Inactivated by FDA | 2026-09-09 | |
| excluded package | package | 52959-737 | 52959-737-40 | I | Inactivated by FDA | 2026-09-09 | |
| excluded package | package | 52959-737 | 52959-737-42 | I | Inactivated by FDA | 2026-09-09 | |
| excluded package | package | 52959-737 | 52959-737-45 | I | Inactivated by FDA | 2026-09-09 | |
| excluded package | package | 52959-737 | 52959-737-50 | I | Inactivated by FDA | 2026-09-09 | |
| excluded package | package | 52959-737 | 52959-737-60 | I | Inactivated by FDA | 2026-09-09 | |
| excluded package | package | 52959-737 | 52959-737-90 | I | Inactivated by FDA | 2026-09-09 | |
| excluded package | package | 52959-737 | 52959-737-00 | I | Inactivated by FDA | 2026-09-09 | |
| excluded package | package | 52959-737 | 52959-737-04 | I | Inactivated by FDA | 2026-09-09 | |
| excluded package | package | 52959-737 | 52959-737-10 | I | Inactivated by FDA | 2026-09-09 | |
| excluded package | package | 52959-737 | 52959-737-14 | I | Inactivated by FDA | 2026-09-09 | |
| excluded package | package | 52959-737 | 52959-737-16 | I | Inactivated by FDA | 2026-09-09 | |
| excluded package | package | 52959-737 | 52959-737-21 | I | Inactivated by FDA | 2026-09-09 | |
| excluded package | package | 52959-737 | 52959-737-24 | I | Inactivated by FDA | 2026-09-09 |
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 product | product | d630ba8d3edf… | 732f749b63fb… | |
| 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 | 52959-737-40 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 52959-737-30 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 52959-737-14 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 52959-737-12 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 52959-737-60 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 52959-737-90 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 52959-737-04 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 52959-737-28 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 52959-737-45 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 52959-737-24 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 52959-737-21 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 52959-737-20 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 52959-737-15 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 52959-737-42 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 52959-737-10 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 52959-737-16 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 52959-737-50 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 52959-737-00 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 52959-737-02 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 52959-737-25 | 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 product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 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 | 52959-737-40 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 52959-737-30 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 52959-737-14 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 52959-737-12 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 52959-737-60 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 52959-737-90 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 52959-737-04 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 52959-737-28 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 52959-737-45 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 52959-737-24 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 52959-737-21 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 52959-737-20 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 52959-737-15 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 52959-737-42 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 52959-737-10 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 52959-737-16 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 52959-737-50 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 52959-737-00 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 52959-737-02 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 52959-737-25 | 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 product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 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 | 52959-737-40 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 52959-737-30 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 52959-737-14 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 52959-737-12 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 52959-737-60 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 52959-737-90 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 52959-737-04 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 52959-737-28 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 52959-737-45 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 52959-737-24 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 52959-737-21 | 2ef7874e63bc… | 57b86245f4fa… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A040736-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 325MG;5MG | TABLET / ORAL | AA | 2006-08-25 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A040736-001 | AA |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A040736-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2006-08-25 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A040736-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2006-08-25 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040736-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2006-08-25 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A040736-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2006-08-25 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040736-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2006-08-25 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040736-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2006-08-25 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040736-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2006-08-25 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040736-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2006-08-25 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040736-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2006-08-25 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040736-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2006-08-25 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A040736-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2006-08-25 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040736-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2006-08-25 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040736-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2006-08-25 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040736-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2006-08-25 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A040736-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2006-08-25 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040736-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2006-08-25 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A040736-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2006-08-25 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A040736-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2006-08-25 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A040736-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2006-08-25 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A040736-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2006-08-25 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A040736-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2006-08-25 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A040736-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2006-08-25 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A040736-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2006-08-25 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A040736-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2006-08-25 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A040736-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2006-08-25 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A040736-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2006-08-25 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A040736-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2006-08-25 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A040736-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2006-08-25 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A040736-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2006-08-25 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A040736-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2006-08-25 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A040736-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2006-08-25 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A040736-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2006-08-25 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A040736-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2006-08-25 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A040736-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2006-08-25 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A040736-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2006-08-25 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A040736-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2006-08-25 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A040736-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2006-08-25 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A040736-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2006-08-25 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A040736-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2006-08-25 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | A040736-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2006-08-25 | e64feba35796… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A040736-001 | AA | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A040736-001 | AA | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040736-001 | AA | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A040736-001 | AA | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040736-001 | AA | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040736-001 | AA | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040736-001 | AA | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040736-001 | AA | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040736-001 | AA | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040736-001 | AA | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A040736-001 | AA | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040736-001 | AA | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040736-001 | AA | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040736-001 | AA | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A040736-001 | AA | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040736-001 | AA | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A040736-001 | AA | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A040736-001 | AA | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A040736-001 | AA | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A040736-001 | AA | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A040736-001 | AA | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A040736-001 | AA | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A040736-001 | AA | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A040736-001 | AA | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A040736-001 | AA | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A040736-001 | AA | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A040736-001 | AA | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A040736-001 | AA | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A040736-001 | AA | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A040736-001 | AA | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A040736-001 | AA | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A040736-001 | AA | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A040736-001 | AA | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A040736-001 | AA | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A040736-001 | AA | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A040736-001 | AA | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A040736-001 | AA | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A040736-001 | AA | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A040736-001 | AA | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A040736-001 | AA | 1 | e64feba35796… |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 52959-737-02 | Hydrocodone Bitartrate and Acetaminophen | 120 in 1 BOTTLE | TABLET | 120 | 5 | |
| 52959-737-15 | Hydrocodone Bitartrate and Acetaminophen | 15 in 1 BOTTLE | TABLET | 15 | 5 | |
| 52959-737-20 | Hydrocodone Bitartrate and Acetaminophen | 20 in 1 BOTTLE | TABLET | 20 | 5 | |
| 52959-737-25 | Hydrocodone Bitartrate and Acetaminophen | 25 in 1 BOTTLE | TABLET | 25 | 5 | |
| 52959-737-28 | Hydrocodone Bitartrate and Acetaminophen | 28 in 1 BOTTLE | TABLET | 28 | 5 | |
| 52959-737-30 | Hydrocodone Bitartrate and Acetaminophen | 30 in 1 BOTTLE | TABLET | 30 | 5 | |
| 52959-737-40 | Hydrocodone Bitartrate and Acetaminophen | 40 in 1 BOTTLE | TABLET | 40 | 5 | |
| 52959-737-42 | Hydrocodone Bitartrate and Acetaminophen | 42 in 1 BOTTLE | TABLET | 42 | 5 | |
| 52959-737-45 | Hydrocodone Bitartrate and Acetaminophen | 45 in 1 BOTTLE | TABLET | 45 | 5 | |
| 52959-737-50 | Hydrocodone Bitartrate and Acetaminophen | 50 in 1 BOTTLE | TABLET | 50 | 5 | |
| 52959-737-60 | Hydrocodone Bitartrate and Acetaminophen | 60 in 1 BOTTLE | TABLET | 60 | 5 | |
| 52959-737-90 | Hydrocodone Bitartrate and Acetaminophen | 90 in 1 BOTTLE | TABLET | 90 | 5 | |
| 52959-737-00 | Hydrocodone Bitartrate and Acetaminophen | 100 in 1 BOTTLE | TABLET | 100 | 2 | |
| 52959-737-04 | Hydrocodone Bitartrate and Acetaminophen | 4 in 1 BOTTLE | TABLET | 4 | 2 | |
| 52959-737-10 | Hydrocodone Bitartrate and Acetaminophen | 10 in 1 BOTTLE | TABLET | 10 | 2 | |
| 52959-737-14 | Hydrocodone Bitartrate and Acetaminophen | 14 in 1 BOTTLE | TABLET | 14 | 2 | |
| 52959-737-16 | Hydrocodone Bitartrate and Acetaminophen | 16 in 1 BOTTLE | TABLET | 16 | 2 | |
| 52959-737-21 | Hydrocodone Bitartrate and Acetaminophen | 21 in 1 BOTTLE | TABLET | 21 | 2 | |
| 52959-737-24 | Hydrocodone Bitartrate and Acetaminophen | 24 in 1 BOTTLE | TABLET | 24 | 2 | |
| 52959-737-12 | Hydrocodone Bitartrate and Acetaminophen | 12 in 1 BOTTLE | TABLET | 12 | 1 |
DailyMed Billing Units#
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| ACETAMINOPHEN | ACTIVE INGREDIENT | 362O9ITL9D | HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [H.J. HARKINS COMPANY, INC.] | 5 | |
| HYDROCODONE BITARTRATE | ACTIVE INGREDIENT | NO70W886KK | HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [H.J. HARKINS COMPANY, INC.] | 5 | |
| ACETAMINOPHEN | ACTIVE MOIETY | 362O9ITL9D | HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [H.J. HARKINS COMPANY, INC.] | 5 | |
| HYDROCODONE | ACTIVE MOIETY | 6YKS4Y3WQ7 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [H.J. HARKINS COMPANY, INC.] | 5 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 52959-737 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [H.J. HARKINS COMPANY, INC.] | 5 | Legacy NDC, 12 package rows | 20120425_221c6c53-35b8-4bd7-adfc-f8200b9f49c1.zip |
| 52959-737 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [H.J HARKINS CO., INC] | 2 | Legacy NDC, 7 package rows | 20220919_6983f612-ab66-de4f-e053-2a91aa0ac0c4.zip |
| 52959-737 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [H.J. HARKINS COMPANY, INC.] | 1 | Legacy NDC, 1 package rows | 20171012_5b4e2c4e-4e53-7794-e053-2a91aa0ab4e6.zip |
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 |
|---|---|---|---|---|---|---|
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Amneal Pharmaceuticals of New York LLC | 62be4147-6a72-49e5-9338-10887c65a93a | 2025-10-22 | Boxed warning, Warnings, Adverse reactions | 040736 ANDA040736 |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | AvPAK | 5174bd9a-b777-a6e3-f72f-c16082ee67d3 | 2025-10-21 | Boxed warning, Warnings, Adverse reactions | 040736 ANDA040736 |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | a200d099-fa55-4ef1-b8d7-936a7da1db00 | 2025-09-10 | Boxed warning, Warnings, Adverse reactions | 040736 ANDA040736 |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Proficient Rx LP | 50be5d00-758e-4d01-8e78-40a60dbe67e5 | 2021-01-01 | Boxed warning, Warnings, Adverse reactions | 040736 ANDA040736 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 857002 | HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral Tablet | PSN | 221c6c53-35b8-4bd7-adfc-f8200b9f49c1 | 5 |
| 857002 | acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral Tablet | SCD | 221c6c53-35b8-4bd7-adfc-f8200b9f49c1 | 5 |
| 857002 | APAP 325 MG / hydrocodone bitartrate 5 MG Oral Tablet | SY | 221c6c53-35b8-4bd7-adfc-f8200b9f49c1 | 5 |
| 857002 | HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral Tablet | PSN | 6983f612-ab66-de4f-e053-2a91aa0ac0c4 | 2 |
| 857002 | acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral Tablet | SCD | 6983f612-ab66-de4f-e053-2a91aa0ac0c4 | 2 |
| 857002 | APAP 325 MG / hydrocodone bitartrate 5 MG Oral Tablet | SY | 6983f612-ab66-de4f-e053-2a91aa0ac0c4 | 2 |
| 857002 | HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral Tablet | PSN | 5b4e2c4e-4e53-7794-e053-2a91aa0ab4e6 | 1 |
| 857002 | acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral Tablet | SCD | 5b4e2c4e-4e53-7794-e053-2a91aa0ab4e6 | 1 |
| 857002 | APAP 325 MG / hydrocodone bitartrate 5 MG Oral Tablet | SY | 5b4e2c4e-4e53-7794-e053-2a91aa0ab4e6 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 52959-737-00 | 52959073700 | 100 in 1 BOTTLE | Historical |
| 52959-737-02 | 52959073702 | 120 in 1 BOTTLE | Historical |
| 52959-737-04 | 52959073704 | 4 in 1 BOTTLE | Historical |
| 52959-737-10 | 52959073710 | 10 in 1 BOTTLE | Historical |
| 52959-737-12 | 52959073712 | 12 in 1 BOTTLE | Historical |
| 52959-737-14 | 52959073714 | 14 in 1 BOTTLE | Historical |
| 52959-737-15 | 52959073715 | 15 in 1 BOTTLE | Historical |
| 52959-737-16 | 52959073716 | 16 in 1 BOTTLE | Historical |
| 52959-737-20 | 52959073720 | 20 in 1 BOTTLE | Historical |
| 52959-737-21 | 52959073721 | 21 in 1 BOTTLE | Historical |
| 52959-737-24 | 52959073724 | 24 in 1 BOTTLE | Historical |
| 52959-737-25 | 52959073725 | 25 in 1 BOTTLE | Historical |
| 52959-737-28 | 52959073728 | 28 in 1 BOTTLE | Historical |
| 52959-737-30 | 52959073730 | 30 in 1 BOTTLE | Historical |
| 52959-737-40 | 52959073740 | 40 in 1 BOTTLE | Historical |
| 52959-737-42 | 52959073742 | 42 in 1 BOTTLE | Historical |
| 52959-737-45 | 52959073745 | 45 in 1 BOTTLE | Historical |
| 52959-737-50 | 52959073750 | 50 in 1 BOTTLE | Historical |
| 52959-737-60 | 52959073760 | 60 in 1 BOTTLE | Historical |
| 52959-737-90 | 52959073790 | 90 in 1 BOTTLE | Historical |