Hydrocodone Bitartrate and Acetaminophen
- Product NDC
- 55700-652
- 11-digit product format
- 557000652
- Labeler code
- 55700
- Product ID
- 55700-652_c952c1eb-96c0-4181-8ac9-b849ed5d2788
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocodone Bitartrate and Acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Lake Erie Medical DBA Quality Care Products LLC
- Application
- ANDA209037
- Marketing category
- ANDA
- Marketing start
- 2018-07-13
- Marketing end
- 0000-00-00
- Substance
- ACETAMINOPHEN; HYDROCODONE BITARTRATE
- Active strength
- 325 mg/1; mg/1
- Pharmacologic classes
- Opioid Agonist [EPC], Opioid Agonists [MoA]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- 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 | 55700-652 | D | Discontinued by firm | 2026-08-17 | ||
| excluded package | package | 55700-652 | 55700-652-01 | D | Discontinued by firm | 2026-08-17 | |
| excluded package | package | 55700-652 | 55700-652-10 | D | Discontinued by firm | 2026-08-17 | |
| excluded package | package | 55700-652 | 55700-652-12 | D | Discontinued by firm | 2026-08-17 | |
| excluded package | package | 55700-652 | 55700-652-14 | D | Discontinued by firm | 2026-08-17 | |
| excluded package | package | 55700-652 | 55700-652-15 | D | Discontinued by firm | 2026-08-17 | |
| excluded package | package | 55700-652 | 55700-652-20 | D | Discontinued by firm | 2026-08-17 | |
| excluded package | package | 55700-652 | 55700-652-21 | D | Discontinued by firm | 2026-08-17 | |
| excluded package | package | 55700-652 | 55700-652-30 | D | Discontinued by firm | 2026-08-17 | |
| excluded package | package | 55700-652 | 55700-652-40 | D | Discontinued by firm | 2026-08-17 | |
| excluded package | package | 55700-652 | 55700-652-60 | D | Discontinued by firm | 2026-08-17 | |
| excluded package | package | 55700-652 | 55700-652-90 | 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 | 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 | 55700-652-15 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 55700-652-90 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 55700-652-40 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 55700-652-60 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 55700-652-12 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 55700-652-21 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 55700-652-20 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 55700-652-01 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 55700-652-10 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 55700-652-14 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 55700-652-30 | 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 | 55700-652-15 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 55700-652-90 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 55700-652-40 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 55700-652-60 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 55700-652-12 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 55700-652-21 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 55700-652-20 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 55700-652-01 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 55700-652-10 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 55700-652-14 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 55700-652-30 | 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 | 55700-652-15 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 55700-652-90 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 55700-652-40 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 55700-652-60 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 55700-652-12 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 55700-652-21 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 55700-652-20 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 55700-652-01 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 55700-652-10 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 55700-652-14 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 55700-652-30 | 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 | 55700-652-15 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 55700-652-90 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 55700-652-40 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 55700-652-60 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 55700-652-12 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 55700-652-21 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 55700-652-20 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 55700-652-01 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 55700-652-10 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 55700-652-14 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 55700-652-30 | 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 | 55700-652-15 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 55700-652-90 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 55700-652-40 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 55700-652-60 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 55700-652-12 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 55700-652-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 55700-652-20 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 55700-652-01 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 55700-652-10 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 55700-652-14 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 55700-652-30 | cfe11265f3b6… | 090c488252e2… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A209037-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 325MG;5MG | TABLET / ORAL | AA | 2017-06-21 | |
| A209037-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 325MG;7.5MG | TABLET / ORAL | AA | 2017-06-21 | |
| A209037-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 325MG;10MG | TABLET / ORAL | AA | 2017-06-21 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A209037-001 | AA |
| A209037-002 | AA |
| A209037-003 | 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 | A209037-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2017-06-21 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A209037-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2017-06-21 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A209037-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2017-06-21 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A209037-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2017-06-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A209037-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2017-06-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A209037-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2017-06-21 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209037-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2017-06-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209037-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2017-06-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209037-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2017-06-21 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209037-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2017-06-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209037-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2017-06-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209037-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2017-06-21 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209037-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2017-06-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209037-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2017-06-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209037-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2017-06-21 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209037-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2017-06-21 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209037-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2017-06-21 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209037-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2017-06-21 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209037-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2017-06-21 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209037-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2017-06-21 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209037-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2017-06-21 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209037-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2017-06-21 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209037-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2017-06-21 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209037-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2017-06-21 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209037-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2017-06-21 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209037-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2017-06-21 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209037-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2017-06-21 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209037-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2017-06-21 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209037-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2017-06-21 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209037-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2017-06-21 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A209037-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2017-06-21 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A209037-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2017-06-21 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A209037-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2017-06-21 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A209037-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2017-06-21 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A209037-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2017-06-21 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A209037-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2017-06-21 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A209037-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2017-06-21 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A209037-002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2017-06-21 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A209037-003 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2017-06-21 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A209037-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2017-06-21 | 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 | A209037-001 | AA | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A209037-002 | AA | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A209037-003 | AA | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A209037-001 | AA | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A209037-002 | AA | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A209037-003 | AA | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209037-001 | AA | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209037-002 | AA | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209037-003 | AA | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A209037-001 | AA | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A209037-002 | AA | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A209037-003 | AA | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209037-001 | AA | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209037-002 | AA | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209037-003 | AA | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209037-001 | AA | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209037-002 | AA | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209037-003 | AA | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209037-001 | AA | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209037-002 | AA | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209037-003 | AA | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209037-001 | AA | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209037-002 | AA | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209037-003 | AA | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209037-001 | AA | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209037-002 | AA | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209037-003 | AA | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209037-001 | AA | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209037-002 | AA | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209037-003 | AA | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A209037-001 | AA | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A209037-002 | AA | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A209037-003 | AA | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A209037-001 | AA | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A209037-002 | AA | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A209037-003 | AA | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A209037-001 | AA | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A209037-002 | AA | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A209037-003 | AA | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A209037-001 | AA | 1 | 1e350fbaab3a… |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 55700-652-01 | EA - Each | 55700-652 | 0ff000be-dc47-4fef-a418-162e4b68e151 | 1 | 2018-08-13 |
| 55700-652-10 | EA - Each | 55700-652 | cf4e90c3-100b-4963-b7bb-794623c15f21 | 1 | 2019-07-02 |
| 55700-652-12 | EA - Each | 55700-652 | cb3a26bc-1a19-47fa-8b6b-cf1733ad32cf | 1 | 2018-08-13 |
| 55700-652-14 | EA - Each | 55700-652 | f034a910-886d-47a8-afaf-43d69b12347d | 1 | 2018-08-13 |
| 55700-652-15 | EA - Each | 55700-652 | e9ddc3a0-7b46-4fea-b784-2afd97ab427f | 1 | 2018-08-13 |
| 55700-652-20 | EA - Each | 55700-652 | 694a178c-2874-403f-9d5c-d14896a3441c | 1 | 2018-11-06 |
| 55700-652-21 | EA - Each | 55700-652 | 2ade7782-d33c-487c-871c-677f0611d2c6 | 1 | 2018-08-13 |
| 55700-652-30 | EA - Each | 55700-652 | f909835c-bf7c-46ec-907e-5d3d856fbe0a | 1 | 2018-08-13 |
| 55700-652-40 | EA - Each | 55700-652 | f0f04ddd-e09a-4e59-af3c-43b0ba7bbaab | 1 | 2018-08-13 |
| 55700-652-60 | EA - Each | 55700-652 | 77205683-d1ea-413f-87cc-3d010c905ddc | 1 | 2018-08-13 |
| 55700-652-90 | EA - Each | 55700-652 | 49d58bbb-0116-4ade-aadb-17df2e495974 | 1 | 2018-08-13 |
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 | KVK-Tech, Inc. | f1063950-b302-4898-81c2-b1626c9c16ef | 2026-02-05 | Boxed warning, Warnings, Adverse reactions | 209037 ANDA209037 |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | DirectRx | cc0e654d-1eaa-7d17-e053-2995a90ab1db | 2025-01-17 | Boxed warning, Warnings, Adverse reactions | 209037 ANDA209037 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 55700-652-01 | 55700065201 | 120 TABLET in 1 BOTTLE (55700-652-01) | 120 tablet | 2018-07-13 | 0000-00-00 | No | No | Current |
| 55700-652-10 | 55700065210 | 10 TABLET in 1 BOTTLE (55700-652-10) | 10 tablet | 2019-06-14 | 0000-00-00 | No | No | Current |
| 55700-652-12 | 55700065212 | 12 TABLET in 1 BOTTLE (55700-652-12) | 12 tablet | 2018-07-13 | 0000-00-00 | No | No | Current |
| 55700-652-14 | 55700065214 | 14 TABLET in 1 BOTTLE (55700-652-14) | 14 tablet | 2021-05-07 | 0000-00-00 | No | No | Current |
| 55700-652-15 | 55700065215 | 15 TABLET in 1 BOTTLE (55700-652-15) | 15 tablet | 2018-07-13 | 0000-00-00 | No | No | Current |
| 55700-652-20 | 55700065220 | 20 TABLET in 1 BOTTLE (55700-652-20) | 20 tablet | 2018-09-28 | 0000-00-00 | No | No | Current |
| 55700-652-21 | 55700065221 | 21 TABLET in 1 BOTTLE (55700-652-21) | 21 tablet | 2018-07-13 | 0000-00-00 | No | No | Current |
| 55700-652-30 | 55700065230 | 30 TABLET in 1 BOTTLE (55700-652-30) | 30 tablet | 2018-07-13 | 0000-00-00 | No | No | Current |
| 55700-652-40 | 55700065240 | 40 TABLET in 1 BOTTLE (55700-652-40) | 40 tablet | 2018-07-13 | 0000-00-00 | No | No | Current |
| 55700-652-60 | 55700065260 | 60 TABLET in 1 BOTTLE (55700-652-60) | 60 tablet | 2018-07-13 | 0000-00-00 | No | No | Current |
| 55700-652-90 | 55700065290 | 90 TABLET in 1 BOTTLE (55700-652-90) | 90 tablet | 2018-07-13 | 0000-00-00 | No | No | Current |