Hydrocodone Bitartrate and Acetaminophen
- Product NDC
- 51655-898
- 11-digit product format
- 516550898
- Labeler code
- 51655
- Product ID
- 51655-898_4ea0c6cd-58fb-39fc-e054-00144ff88e88
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocodone Bitartrate and Acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Northwind Pharmaceuticals
- Application
- ANDA201013
- Marketing category
- ANDA
- Marketing start
- 2015-08-11
- 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 | 51655-898 | D | Discontinued by firm | 2026-08-17 | ||
| excluded package | package | 51655-898 | 51655-898-20 | D | Discontinued by firm | 2026-08-17 | |
| excluded package | package | 51655-898 | 51655-898-52 | D | Discontinued by firm | 2026-08-17 | |
| excluded package | package | 51655-898 | 51655-898-53 | D | Discontinued by firm | 2026-08-17 | |
| excluded package | package | 51655-898 | 51655-898-54 | D | Discontinued by firm | 2026-08-17 |
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 | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 51655-898-20 | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 51655-898-54 | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 51655-898-53 | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 51655-898-52 | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | D | Discontinued by firm | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 51655-898-20 | D | Discontinued by firm | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 51655-898-54 | D | Discontinued by firm | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 51655-898-53 | D | Discontinued by firm | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 51655-898-52 | D | Discontinued by firm | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | D | Discontinued by firm | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 51655-898-20 | D | Discontinued by firm | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 51655-898-54 | D | Discontinued by firm | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 51655-898-53 | D | Discontinued by firm | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 51655-898-52 | D | Discontinued by firm | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | D | Discontinued by firm | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 51655-898-20 | D | Discontinued by firm | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 51655-898-54 | D | Discontinued by firm | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 51655-898-53 | D | Discontinued by firm | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 51655-898-52 | D | Discontinued by firm | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | D | Discontinued by firm | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 51655-898-20 | D | Discontinued by firm | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 51655-898-54 | D | Discontinued by firm | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 51655-898-53 | D | Discontinued by firm | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 51655-898-52 | D | Discontinued by firm | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | D | Discontinued by firm | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 51655-898-20 | D | Discontinued by firm | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 51655-898-54 | D | Discontinued by firm | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 51655-898-53 | D | Discontinued by firm | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 51655-898-52 | D | Discontinued by firm | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | D | Discontinued by firm | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 51655-898-20 | D | Discontinued by firm | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 51655-898-54 | D | Discontinued by firm | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 51655-898-53 | D | Discontinued by firm | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 51655-898-52 | D | Discontinued by firm | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | D | Discontinued by firm | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 51655-898-20 | D | Discontinued by firm | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 51655-898-54 | D | Discontinued by firm | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 51655-898-53 | D | Discontinued by firm | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 51655-898-52 | D | Discontinued by firm | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | D | Discontinued by firm | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 51655-898-20 | D | Discontinued by firm | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 51655-898-54 | D | Discontinued by firm | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 51655-898-53 | D | Discontinued by firm | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 51655-898-52 | D | Discontinued by firm | 0efc9e666f02… | f202fb6c5f17… |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded product | product | I | Inactivated by FDA | fb8cb913e6d1… | eb8c232b6be0… | |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 51655-898-20 | I | Inactivated by FDA | fb8cb913e6d1… | eb8c232b6be0… |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 51655-898-52 | I | Inactivated by FDA | fb8cb913e6d1… | eb8c232b6be0… |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 51655-898-53 | I | Inactivated by FDA | fb8cb913e6d1… | eb8c232b6be0… |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 51655-898-54 | I | Inactivated by FDA | fb8cb913e6d1… | eb8c232b6be0… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded product | product | I | Inactivated by FDA | 86f5da6cb304… | a595104c45d7… | |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 51655-898-20 | I | Inactivated by FDA | 86f5da6cb304… | a595104c45d7… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 51655-898-52 | I | Inactivated by FDA | 86f5da6cb304… | a595104c45d7… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 51655-898-53 | I | Inactivated by FDA | 86f5da6cb304… | a595104c45d7… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 51655-898-54 | I | Inactivated by FDA | 86f5da6cb304… | a595104c45d7… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded product | product | I | Inactivated by FDA | bd6a592717d7… | 303034d00443… | |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 51655-898-20 | I | Inactivated by FDA | bd6a592717d7… | 303034d00443… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 51655-898-52 | I | Inactivated by FDA | bd6a592717d7… | 303034d00443… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 51655-898-53 | I | Inactivated by FDA | bd6a592717d7… | 303034d00443… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 51655-898-54 | I | Inactivated by FDA | bd6a592717d7… | 303034d00443… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A201013-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 325MG;5MG | TABLET / ORAL | AA | 2012-04-11 | |
| A201013-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 325MG;7.5MG | TABLET / ORAL | AA | 2012-04-11 | |
| A201013-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 325MG;10MG | TABLET / ORAL | AA | 2012-04-11 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A201013-001 | AA |
| A201013-002 | AA |
| A201013-003 | 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 | A201013-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2012-04-11 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A201013-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2012-04-11 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A201013-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2012-04-11 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A201013-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2012-04-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A201013-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2012-04-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A201013-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2012-04-11 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201013-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2012-04-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201013-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2012-04-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201013-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2012-04-11 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A201013-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2012-04-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A201013-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2012-04-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A201013-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2012-04-11 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201013-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2012-04-11 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201013-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2012-04-11 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201013-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2012-04-11 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201013-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2012-04-11 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201013-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2012-04-11 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201013-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2012-04-11 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201013-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2012-04-11 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201013-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2012-04-11 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201013-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2012-04-11 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A201013-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2012-04-11 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A201013-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2012-04-11 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A201013-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2012-04-11 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A201013-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2012-04-11 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A201013-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2012-04-11 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A201013-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2012-04-11 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A201013-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2012-04-11 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A201013-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2012-04-11 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A201013-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2012-04-11 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A201013-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2012-04-11 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A201013-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2012-04-11 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A201013-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2012-04-11 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A201013-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2012-04-11 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A201013-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2012-04-11 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A201013-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2012-04-11 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A201013-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2012-04-11 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A201013-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2012-04-11 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A201013-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2012-04-11 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A201013-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2012-04-11 | 1e350fbaab3a… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A201013-001 | AA | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A201013-002 | AA | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A201013-003 | AA | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A201013-001 | AA | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A201013-002 | AA | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A201013-003 | AA | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201013-001 | AA | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201013-002 | AA | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201013-003 | AA | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A201013-001 | AA | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A201013-002 | AA | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A201013-003 | AA | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201013-001 | AA | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201013-002 | AA | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201013-003 | AA | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201013-001 | AA | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201013-002 | AA | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201013-003 | AA | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201013-001 | AA | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201013-002 | AA | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201013-003 | AA | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A201013-001 | AA | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A201013-002 | AA | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A201013-003 | AA | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A201013-001 | AA | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A201013-002 | AA | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A201013-003 | AA | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A201013-001 | AA | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A201013-002 | AA | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A201013-003 | AA | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A201013-001 | AA | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A201013-002 | AA | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A201013-003 | AA | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A201013-001 | AA | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A201013-002 | AA | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A201013-003 | AA | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A201013-001 | AA | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A201013-002 | AA | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A201013-003 | AA | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A201013-001 | AA | 1 | 1e350fbaab3a… |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Related label |
|---|---|---|
| 51655-898-20 | 2023-07-18 | Hydrocodone Bitartrate and Acetaminophen Tablets, USP |
| 51655-898-52 | 2023-07-18 | Hydrocodone Bitartrate and Acetaminophen Tablets, USP |
| 51655-898-53 | 2023-07-18 | Hydrocodone Bitartrate and Acetaminophen Tablets, USP |
| 51655-898-54 | 2023-07-18 | Hydrocodone Bitartrate and Acetaminophen Tablets, USP |
| 51655-898-20 | 2020-01-31 | Hydrocodone Bitartrate and Acetaminophen Tablets, USP |
| 51655-898-52 | 2020-01-31 | Hydrocodone Bitartrate and Acetaminophen Tablets, USP |
| 51655-898-53 | 2020-01-31 | Hydrocodone Bitartrate and Acetaminophen Tablets, USP |
| 51655-898-54 | 2020-01-31 | Hydrocodone Bitartrate and Acetaminophen Tablets, USP |
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 | Bryant Ranch Prepack | ddfe71cc-27bf-4807-b62f-e6cf982e2dfd | 2026-06-11 | Boxed warning, Warnings, Adverse reactions | 201013 ANDA201013 |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | 88c031ee-3d3d-4e8a-b69b-d18db612a9f3 | 2026-01-26 | Boxed warning, Warnings, Adverse reactions | 201013 ANDA201013 |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Aurolife Pharma, LLC | 60f43308-1deb-4f05-8f17-aa49ebdcf498 | 2025-12-11 | Boxed warning, Warnings, Adverse reactions | 201013 ANDA201013 |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | 59a92d79-5b2d-4c10-b0ac-ea766a0ff08b | 2024-10-08 | Boxed warning, Warnings, Adverse reactions | 201013 ANDA201013 |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | NuCare Pharmaceuticals,Inc. | 8b132cf3-c138-59ae-e053-2995a90a98a2 | 2024-08-14 | Boxed warning, Warnings, Adverse reactions | 201013 ANDA201013 |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | NuCare Pharmaceuticals,Inc. | 8c2a7a68-5a84-c909-e053-2995a90ad5b6 | 2024-06-18 | Boxed warning, Warnings, Adverse reactions | 201013 ANDA201013 |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | NuCare Pharmaceuticals,Inc. | 8592e901-9353-6fb6-e053-2a91aa0ad33b | 2024-06-14 | Boxed warning, Warnings, Adverse reactions | 201013 ANDA201013 |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | NuCare Pharmaceuticals,Inc. | 86be8920-2f35-fbc3-e053-2991aa0a0015 | 2024-06-14 | Boxed warning, Warnings, Adverse reactions | 201013 ANDA201013 |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Proficient Rx LP | 82b24978-8b15-43a9-b5b0-3313ed2a73c2 | 2023-04-01 | Boxed warning, Warnings, Adverse reactions | 201013 ANDA201013 |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Proficient Rx LP | e6711f26-a01d-43e8-882a-d58561e4b67f | 2022-10-01 | Boxed warning, Warnings, Adverse reactions | 201013 ANDA201013 |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Proficient Rx LP | 199d4915-cb3b-48f3-835d-a45d04a5c940 | 2022-04-01 | Boxed warning, Warnings, Adverse reactions | 201013 ANDA201013 |