Hycet
- Product NDC
- 0713-0703
- 11-digit product format
- 007130703
- Labeler code
- 0713
- Product ID
- 0713-0703_3bb57616-ce87-5a68-17d7-8dc7f2963a1f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocodone bitartrate and acetaminophen
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- G&W Laboratories, Inc.
- Application
- ANDA040482
- Marketing category
- ANDA
- Marketing start
- 2011-02-01
- Marketing end
- 0000-00-00
- Substance
- HYDROCODONE BITARTRATE; ACETAMINOPHEN
- Active strength
- 8 mg/15mL; mg/15mL
- 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
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 |
|---|---|---|---|---|---|
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 0713-0703-89 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 0713-0703-89 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 0713-0703-89 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 0713-0703-89 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded product | product | 8af77b9d5b6f… | d9bbb34c5368… | |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 0713-0703-89 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded product | product | 834df4deac94… | adcc014656a3… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 0713-0703-89 | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded product | product | 1332a3947898… | d4bfe170f9cd… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 0713-0703-89 | 1332a3947898… | d4bfe170f9cd… |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded product | product | fb8cb913e6d1… | eb8c232b6be0… | |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 0713-0703-89 | fb8cb913e6d1… | eb8c232b6be0… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded product | product | 86f5da6cb304… | a595104c45d7… | |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 0713-0703-89 | 86f5da6cb304… | a595104c45d7… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded product | product | bd6a592717d7… | 303034d00443… | |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 0713-0703-89 | bd6a592717d7… | 303034d00443… |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded product | product | 8dfbde2a14a4… | c9ff85d89658… | |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded package | package | 0713-0703-89 | 8dfbde2a14a4… | c9ff85d89658… |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded product | product | e2bbac7714bc… | 27bdfed8d636… | |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded package | package | 0713-0703-89 | e2bbac7714bc… | 27bdfed8d636… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded product | product | 9bebd1f3094a… | 5416666fcb17… | |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded package | package | 0713-0703-89 | 9bebd1f3094a… | 5416666fcb17… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A040482-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 325MG/15ML;7.5MG/15ML | SOLUTION / ORAL | 2003-09-25 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A040482-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG/15ML;7.5MG/15ML | SOLUTION / ORAL | 2003-09-25 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040482-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG/15ML;7.5MG/15ML | SOLUTION / ORAL | 2003-09-25 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A040482-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG/15ML;7.5MG/15ML | SOLUTION / ORAL | 2003-09-25 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040482-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG/15ML;7.5MG/15ML | SOLUTION / ORAL | 2003-09-25 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040482-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG/15ML;7.5MG/15ML | SOLUTION / ORAL | AA | RS | 2003-09-25 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040482-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG/15ML;7.5MG/15ML | SOLUTION / ORAL | AA | RS | 2003-09-25 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040482-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG/15ML;7.5MG/15ML | SOLUTION / ORAL | AA | RS | 2003-09-25 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040482-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG/15ML;7.5MG/15ML | SOLUTION / ORAL | AA | RS | 2003-09-25 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040482-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG/15ML;7.5MG/15ML | SOLUTION / ORAL | AA | RS | 2003-09-25 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A040482-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG/15ML;7.5MG/15ML | SOLUTION / ORAL | AA | RS | 2003-09-25 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040482-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG/15ML;7.5MG/15ML | SOLUTION / ORAL | AA | RS | 2003-09-25 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040482-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG/15ML;7.5MG/15ML | SOLUTION / ORAL | AA | RS | 2003-09-25 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040482-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG/15ML;7.5MG/15ML | SOLUTION / ORAL | AA | RS | 2003-09-25 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A040482-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG/15ML;7.5MG/15ML | SOLUTION / ORAL | AA | RS | 2003-09-25 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040482-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG/15ML;7.5MG/15ML | SOLUTION / ORAL | AA | RS | 2003-09-25 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A040482-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG/15ML;7.5MG/15ML | SOLUTION / ORAL | AA | RS | 2003-09-25 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A040482-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG/15ML;7.5MG/15ML | SOLUTION / ORAL | AA | RS | 2003-09-25 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A040482-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG/15ML;7.5MG/15ML | SOLUTION / ORAL | AA | RS | 2003-09-25 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A040482-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG/15ML;7.5MG/15ML | SOLUTION / ORAL | AA | RS | 2003-09-25 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A040482-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG/15ML;7.5MG/15ML | SOLUTION / ORAL | AA | RS | 2003-09-25 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A040482-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG/15ML;7.5MG/15ML | SOLUTION / ORAL | AA | RS | 2003-09-25 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A040482-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG/15ML;7.5MG/15ML | SOLUTION / ORAL | AA | RS | 2003-09-25 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A040482-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG/15ML;7.5MG/15ML | SOLUTION / ORAL | AA | RS | 2003-09-25 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A040482-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG/15ML;7.5MG/15ML | SOLUTION / ORAL | AA | RS | 2003-09-25 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A040482-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG/15ML;7.5MG/15ML | SOLUTION / ORAL | AA | RS | 2003-09-25 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A040482-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG/15ML;7.5MG/15ML | SOLUTION / ORAL | AA | RS | 2003-09-25 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A040482-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG/15ML;7.5MG/15ML | SOLUTION / ORAL | AA | RS | 2003-09-25 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A040482-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG/15ML;7.5MG/15ML | SOLUTION / ORAL | AA | RS | 2003-09-25 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A040482-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG/15ML;7.5MG/15ML | SOLUTION / ORAL | AA | RS | 2003-09-25 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A040482-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG/15ML;7.5MG/15ML | SOLUTION / ORAL | AA | RS | 2003-09-25 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A040482-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG/15ML;7.5MG/15ML | SOLUTION / ORAL | AA | RS | 2003-09-25 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A040482-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG/15ML;7.5MG/15ML | SOLUTION / ORAL | AA | RS | 2003-09-25 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A040482-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG/15ML;7.5MG/15ML | SOLUTION / ORAL | AA | RS | 2003-09-25 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A040482-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG/15ML;7.5MG/15ML | SOLUTION / ORAL | AA | RS | 2003-09-25 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A040482-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG/15ML;7.5MG/15ML | SOLUTION / ORAL | AA | RS | 2003-09-25 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A040482-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG/15ML;7.5MG/15ML | SOLUTION / ORAL | AA | RS | 2003-09-25 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A040482-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG/15ML;7.5MG/15ML | SOLUTION / ORAL | AA | RS | 2003-09-25 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A040482-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG/15ML;7.5MG/15ML | SOLUTION / ORAL | AA | RS | 2003-09-25 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A040482-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG/15ML;7.5MG/15ML | SOLUTION / ORAL | AA | RS | 2003-09-25 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A040482-001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 325MG/15ML;7.5MG/15ML | SOLUTION / ORAL | AA | RS | 2003-09-25 | cb3db0bc1861… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040482-001 | AA | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040482-001 | AA | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040482-001 | AA | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040482-001 | AA | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040482-001 | AA | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A040482-001 | AA | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040482-001 | AA | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040482-001 | AA | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040482-001 | AA | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A040482-001 | AA | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040482-001 | AA | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A040482-001 | AA | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A040482-001 | AA | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A040482-001 | AA | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A040482-001 | AA | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A040482-001 | AA | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A040482-001 | AA | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A040482-001 | AA | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A040482-001 | AA | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A040482-001 | AA | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A040482-001 | AA | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A040482-001 | AA | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A040482-001 | AA | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A040482-001 | AA | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A040482-001 | AA | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A040482-001 | AA | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A040482-001 | AA | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A040482-001 | AA | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A040482-001 | AA | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A040482-001 | AA | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A040482-001 | AA | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A040482-001 | AA | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A040482-001 | AA | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A040482-001 | AA | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A040482-001 | AA | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A040482-001 | AA | 1 | cb3db0bc1861… |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0713-0703-89 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-925c-f424-e053-dadaa90a57ce | Hycet ® CII hydrocodone bitartrate and acetaminophen oral solution 7.5 mg/325 mg per 15 mL Rx only |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0713-0703-89 | ML - Milliliter | 0713-0703 | b0afc139-f480-4e64-b640-ff6afc769fd6 | 1 | 2014-07-02 |