Hydrocodone Bitartrate and Acetaminophen
- Product NDC
- 55700-781
- 11-digit product format
- 557000781
- Labeler code
- 55700
- Product ID
- 55700-781_193b0971-d1ac-425e-b234-d4c425742361
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocodone Bitartrate and Acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Quality Care Products, LLC
- Application
- ANDA211487
- Marketing category
- ANDA
- Marketing start
- 2019-07-26
- Marketing end
- 0000-00-00
- Substance
- HYDROCODONE BITARTRATE; ACETAMINOPHEN
- Active strength
- 10 mg/1; mg/1
- Pharmacologic classes
- Opioid Agonist [EPC],Opioid Agonists [MoA]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- 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 | 55700-781 | D | Discontinued by firm | 2026-09-14 | ||
| excluded package | package | 55700-781 | 55700-781-01 | D | Discontinued by firm | 2026-09-14 | |
| excluded package | package | 55700-781 | 55700-781-10 | D | Discontinued by firm | 2026-09-14 | |
| excluded package | package | 55700-781 | 55700-781-21 | D | Discontinued by firm | 2026-09-14 | |
| excluded package | package | 55700-781 | 55700-781-30 | D | Discontinued by firm | 2026-09-14 | |
| excluded package | package | 55700-781 | 55700-781-40 | D | Discontinued by firm | 2026-09-14 | |
| excluded package | package | 55700-781 | 55700-781-60 | D | Discontinued by firm | 2026-09-14 | |
| excluded package | package | 55700-781 | 55700-781-90 | D | Discontinued by firm | 2026-09-14 |
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 | 55700-781-10 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 55700-781-30 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 55700-781-21 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 55700-781-40 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 55700-781-60 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 55700-781-90 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 55700-781-01 | 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 | 55700-781-10 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 55700-781-30 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 55700-781-21 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 55700-781-40 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 55700-781-60 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 55700-781-90 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 55700-781-01 | 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 | 55700-781-10 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 55700-781-30 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 55700-781-21 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 55700-781-40 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 55700-781-60 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 55700-781-90 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 55700-781-01 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 55700-781-10 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 55700-781-30 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 55700-781-21 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 55700-781-40 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 55700-781-60 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 55700-781-90 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 55700-781-01 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 55700-781-10 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 55700-781-30 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 55700-781-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 55700-781-40 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 55700-781-60 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 55700-781-90 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 55700-781-01 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 55700-781-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 55700-781-30 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 55700-781-21 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 55700-781-40 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 55700-781-60 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 55700-781-90 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 55700-781-01 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 55700-781-10 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 55700-781-30 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 55700-781-21 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 55700-781-40 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 55700-781-60 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 55700-781-90 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 55700-781-01 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 55700-781-10 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 55700-781-30 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 55700-781-21 | ed331223b511… | 672a5bd82f5f… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A211487-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 325MG;2.5MG | TABLET / ORAL | AA | RS | 2018-11-07 |
| A211487-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 325MG;5MG | TABLET / ORAL | AA | 2018-11-07 | |
| A211487-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 325MG;7.5MG | TABLET / ORAL | AA | 2018-11-07 | |
| A211487-004 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 325MG;10MG | TABLET / ORAL | AA | 2018-11-07 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A211487-001 | AA |
| A211487-002 | AA |
| A211487-003 | AA |
| A211487-004 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A211487-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;2.5MG | TABLET / ORAL | AA | RS | 2018-11-07 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A211487-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2018-11-07 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A211487-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2018-11-07 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A211487-004 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2018-11-07 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A211487-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;2.5MG | TABLET / ORAL | AA | RS | 2018-11-07 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A211487-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2018-11-07 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A211487-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2018-11-07 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A211487-004 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2018-11-07 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A211487-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;2.5MG | TABLET / ORAL | AA | RS | 2018-11-07 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A211487-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2018-11-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A211487-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2018-11-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A211487-004 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2018-11-07 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211487-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;2.5MG | TABLET / ORAL | AA | RS | 2018-11-07 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211487-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2018-11-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211487-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2018-11-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211487-004 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2018-11-07 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A211487-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;2.5MG | TABLET / ORAL | AA | RS | 2018-11-07 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A211487-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2018-11-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A211487-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2018-11-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A211487-004 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2018-11-07 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211487-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;2.5MG | TABLET / ORAL | AA | RS | 2018-11-07 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211487-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2018-11-07 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211487-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2018-11-07 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211487-004 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2018-11-07 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211487-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;2.5MG | TABLET / ORAL | AA | RS | 2018-11-07 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211487-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2018-11-07 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211487-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2018-11-07 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211487-004 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2018-11-07 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211487-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;2.5MG | TABLET / ORAL | AA | RS | 2018-11-07 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211487-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2018-11-07 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211487-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2018-11-07 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211487-004 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2018-11-07 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211487-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;2.5MG | TABLET / ORAL | AA | RS | 2018-11-07 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211487-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2018-11-07 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211487-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2018-11-07 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211487-004 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2018-11-07 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211487-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;2.5MG | TABLET / ORAL | RS | 2018-11-07 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211487-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2018-11-07 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211487-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2018-11-07 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211487-004 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2018-11-07 | 5bbf6a4d5a75… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A211487-001 | AA | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A211487-002 | AA | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A211487-003 | AA | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A211487-004 | AA | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A211487-001 | AA | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A211487-002 | AA | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A211487-003 | AA | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A211487-004 | AA | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A211487-001 | AA | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A211487-002 | AA | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A211487-003 | AA | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A211487-004 | AA | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211487-001 | AA | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211487-002 | AA | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211487-003 | AA | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211487-004 | AA | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A211487-001 | AA | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A211487-002 | AA | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A211487-003 | AA | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A211487-004 | AA | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211487-001 | AA | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211487-002 | AA | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211487-003 | AA | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211487-004 | AA | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211487-001 | AA | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211487-002 | AA | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211487-003 | AA | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211487-004 | AA | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211487-001 | AA | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211487-002 | AA | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211487-003 | AA | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211487-004 | AA | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211487-001 | AA | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211487-002 | AA | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211487-003 | AA | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211487-004 | AA | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211487-002 | AA | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211487-003 | AA | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211487-004 | AA | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A211487-001 | AA | 1 | d8e5a09893c0… |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Related label |
|---|---|---|
| 55700-781-01 | 2025-01-10 | d68de0b1-9437-447c-b2bb-a028b1109781 |
| 55700-781-10 | 2025-01-10 | d68de0b1-9437-447c-b2bb-a028b1109781 |
| 55700-781-21 | 2025-01-10 | d68de0b1-9437-447c-b2bb-a028b1109781 |
| 55700-781-30 | 2025-01-10 | d68de0b1-9437-447c-b2bb-a028b1109781 |
| 55700-781-40 | 2025-01-10 | d68de0b1-9437-447c-b2bb-a028b1109781 |
| 55700-781-60 | 2025-01-10 | d68de0b1-9437-447c-b2bb-a028b1109781 |
| 55700-781-90 | 2025-01-10 | d68de0b1-9437-447c-b2bb-a028b1109781 |
| 55700-781-01 | 2023-01-30 | d68de0b1-9437-447c-b2bb-a028b1109781 |
| 55700-781-10 | 2023-01-30 | d68de0b1-9437-447c-b2bb-a028b1109781 |
| 55700-781-21 | 2023-01-30 | d68de0b1-9437-447c-b2bb-a028b1109781 |
| 55700-781-30 | 2023-01-30 | d68de0b1-9437-447c-b2bb-a028b1109781 |
| 55700-781-40 | 2023-01-30 | d68de0b1-9437-447c-b2bb-a028b1109781 |
| 55700-781-60 | 2023-01-30 | d68de0b1-9437-447c-b2bb-a028b1109781 |
| 55700-781-90 | 2023-01-30 | d68de0b1-9437-447c-b2bb-a028b1109781 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 55700-781-01 | EA - Each | 55700-781 | a1a9a633-c07c-40bb-ad5d-bff99a4691b1 | 1 | 2019-09-05 |
| 55700-781-21 | EA - Each | 55700-781 | 9a1bad39-0758-49f5-8c0e-bd5afca85717 | 1 | 2021-02-05 |
| 55700-781-30 | EA - Each | 55700-781 | af378d59-a36c-43be-b4b7-ab50df76436f | 1 | 2020-05-08 |
| 55700-781-40 | EA - Each | 55700-781 | 0521f58d-7e89-4c83-91f7-5c027a7109c9 | 1 | 2019-10-07 |
| 55700-781-60 | EA - Each | 55700-781 | 6511b230-3645-4c8b-a128-9a3be9970e9e | 1 | 2019-09-05 |
| 55700-781-90 | EA - Each | 55700-781 | 2a7bf0f0-829e-4062-afe9-68d8ee20a474 | 1 | 2019-09-05 |
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 | c4dc75b4-8016-4875-a859-6346c48cc0e7 | 2025-10-24 | Boxed warning, Warnings, Adverse reactions | 211487 ANDA211487 |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | 39b8382a-e96d-462d-895f-27cbb9a305ec | 2025-10-22 | Boxed warning, Warnings, Adverse reactions | 211487 ANDA211487 |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | ac88fa99-625b-4854-a406-9e21a6b9c1c8 | 2025-10-21 | Boxed warning, Warnings, Adverse reactions | 211487 ANDA211487 |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | ee4b164d-7ee2-4c19-b1a3-cb60c6676786 | 2025-10-21 | Boxed warning, Warnings, Adverse reactions | 211487 ANDA211487 |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | 94ba2279-440e-4eaf-ad19-04d90a5c4c10 | 2025-10-21 | Boxed warning, Warnings, Adverse reactions | 211487 ANDA211487 |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | 177c4cd8-80dd-4ed7-9e12-dcec70e0278e | 2025-10-21 | Boxed warning, Warnings, Adverse reactions | 211487 ANDA211487 |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | 96a84a12-da15-410a-9c70-af125f2fcacc | 2025-10-08 | Boxed warning, Warnings, Adverse reactions | 211487 ANDA211487 |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | 5d5fa7bb-6416-48dc-95a0-43ffd84cb595 | 2025-10-08 | Boxed warning, Warnings, Adverse reactions | 211487 ANDA211487 |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Bryant Ranch Prepack | 72244b9c-eac4-41c2-8ba6-7302eafba90a | 2025-10-07 | Boxed warning, Warnings, Adverse reactions | 211487 ANDA211487 |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Camber Pharmaceuticals, Inc. | 4d5bfd3a-3793-4d24-aedd-c04fa34ea736 | 2025-08-26 | Boxed warning, Warnings, Adverse reactions | 211487 ANDA211487 |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Camber Pharmaceuticals, Inc. | ed6af366-753c-4f3b-a6a2-c9a183c50035 | 2025-08-21 | Boxed warning, Warnings, Adverse reactions | 211487 ANDA211487 |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Direct Rx | db73b8ed-9747-6a49-e053-2a95a90a93a1 | 2025-02-21 | Adverse reactions | 211487 ANDA211487 |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | DirectRx | dd934235-3b2a-51ca-e053-2995a90a0016 | 2025-02-21 | Warnings, Adverse reactions | 211487 ANDA211487 |
| Hydrocodone APAP | HYDROCODONE APAP | Direct_Rx | deaa53c1-81ed-7497-e053-2995a90a07cc | 2025-01-28 | Warnings, Adverse reactions | 211487 ANDA211487 |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | XLCare Pharmaceuticals, Inc. | b9f61b9c-d3f9-47e3-94a3-b5228f96f927 | 2023-09-25 | Boxed warning, Warnings, Adverse reactions | 211487 ANDA211487 |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Proficient Rx LP | c6210466-5feb-45d9-b637-b3f482bc3c2b | 2022-05-01 | Boxed warning, Warnings, Adverse reactions | 211487 ANDA211487 |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | XLCare Pharmaceuticals, Inc. | 73dea6de-20cb-4cef-b987-3ab2c64e5edb | 2019-11-21 | Boxed warning, Warnings, Adverse reactions | 211487 ANDA211487 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 55700-781-01 | 55700078101 | 120 TABLET in 1 BOTTLE (55700-781-01) | 120 tablet | 2019-07-26 | 0000-00-00 | No | No | Current |
| 55700-781-10 | 55700078110 | 30 TABLET in 1 BOTTLE (55700-781-10) | 30 tablet | 2019-07-26 | 0000-00-00 | No | No | Current |
| 55700-781-21 | 55700078121 | 21 TABLET in 1 BOTTLE (55700-781-21) | 21 tablet | 2021-01-07 | 0000-00-00 | No | No | Current |
| 55700-781-30 | 55700078130 | 30 TABLET in 1 BOTTLE (55700-781-30) | 30 tablet | 2019-07-26 | 0000-00-00 | No | No | Current |
| 55700-781-40 | 55700078140 | 40 TABLET in 1 BOTTLE (55700-781-40) | 40 tablet | 2019-08-16 | 0000-00-00 | No | No | Current |
| 55700-781-60 | 55700078160 | 60 TABLET in 1 BOTTLE (55700-781-60) | 60 tablet | 2019-07-26 | 0000-00-00 | No | No | Current |
| 55700-781-90 | 55700078190 | 90 TABLET in 1 BOTTLE (55700-781-90) | 90 tablet | 2019-07-26 | 0000-00-00 | No | No | Current |