Oxycodone and Acetaminophen
- Product NDC
- 67296-1401
- Requested package NDC
- 67296-1401-8
- 11-digit product format
- 672961401
- Labeler code
- 67296
- Product ID
- 67296-1401_9c9fa3e2-20d5-7794-e053-2a95a90a4727
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Oxycodone and Acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- RedPharm Drug, Inc.
- Application
- ANDA090177
- Marketing category
- ANDA
- Marketing start
- 2008-12-16
- Marketing end
- 0000-00-00
- Substance
- ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
- Active strength
- 325 mg/1; mg/1
- Pharmacologic classes
- Full Opioid Agonists [MoA],Opioid Agonist [EPC]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- 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 package | package | 67296-1401 | 67296-1401-8 | I | Inactivated by FDA | 2026-08-03 |
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 | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | I | Inactivated by FDA | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | I | Inactivated by FDA | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | I | Inactivated by FDA | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | I | Inactivated by FDA | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | I | Inactivated by FDA | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | I | Inactivated by FDA | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | I | Inactivated by FDA | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | I | Inactivated by FDA | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | I | Inactivated by FDA | 1332a3947898… | d4bfe170f9cd… |
| 2022-08-30 03:57 UTC · source 2022-08-29 | I | Inactivated by FDA | fb8cb913e6d1… | eb8c232b6be0… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | I | Inactivated by FDA | 86f5da6cb304… | a595104c45d7… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | I | Inactivated by FDA | bd6a592717d7… | 303034d00443… |
| 2019-12-08 06:16 UTC · source 2019-12-05 | E | Excluded after deficient or non-compliant submission was not corrected | 110d247fa046… | a55b01930146… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A090177-001 | OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;2.5MG | TABLET / ORAL | 2008-10-20 | ||
| A090177-002 | OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;5MG | TABLET / ORAL | 2008-10-20 | ||
| A090177-003 | OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;7.5MG | TABLET / ORAL | 2008-10-20 | ||
| A090177-004 | OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;10MG | TABLET / ORAL | 2008-10-20 | ||
| A090177-005 | OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 500MG;7.5MG | TABLET / ORAL | 2008-10-20 | ||
| A090177-006 | OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 650MG;10MG | TABLET / ORAL | 2008-10-20 |
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 | A090177-001 | OXYCODONE AND ACETAMINOPHEN | 325MG;2.5MG | TABLET / ORAL | 2008-10-20 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A090177-002 | OXYCODONE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | 2008-10-20 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A090177-003 | OXYCODONE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | 2008-10-20 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A090177-004 | OXYCODONE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | 2008-10-20 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A090177-005 | OXYCODONE AND ACETAMINOPHEN | 500MG;7.5MG | TABLET / ORAL | 2008-10-20 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A090177-006 | OXYCODONE AND ACETAMINOPHEN | 650MG;10MG | TABLET / ORAL | 2008-10-20 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090177-001 | OXYCODONE AND ACETAMINOPHEN | 325MG;2.5MG | TABLET / ORAL | 2008-10-20 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090177-002 | OXYCODONE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | 2008-10-20 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090177-003 | OXYCODONE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | 2008-10-20 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090177-004 | OXYCODONE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | 2008-10-20 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090177-005 | OXYCODONE AND ACETAMINOPHEN | 500MG;7.5MG | TABLET / ORAL | 2008-10-20 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090177-006 | OXYCODONE AND ACETAMINOPHEN | 650MG;10MG | TABLET / ORAL | 2008-10-20 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A090177-001 | OXYCODONE AND ACETAMINOPHEN | 325MG;2.5MG | TABLET / ORAL | 2008-10-20 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A090177-002 | OXYCODONE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | 2008-10-20 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A090177-003 | OXYCODONE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | 2008-10-20 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A090177-004 | OXYCODONE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | 2008-10-20 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A090177-005 | OXYCODONE AND ACETAMINOPHEN | 500MG;7.5MG | TABLET / ORAL | 2008-10-20 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A090177-006 | OXYCODONE AND ACETAMINOPHEN | 650MG;10MG | TABLET / ORAL | 2008-10-20 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090177-001 | OXYCODONE AND ACETAMINOPHEN | 325MG;2.5MG | TABLET / ORAL | 2008-10-20 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090177-002 | OXYCODONE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | 2008-10-20 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090177-003 | OXYCODONE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | 2008-10-20 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090177-004 | OXYCODONE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | 2008-10-20 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090177-005 | OXYCODONE AND ACETAMINOPHEN | 500MG;7.5MG | TABLET / ORAL | 2008-10-20 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090177-006 | OXYCODONE AND ACETAMINOPHEN | 650MG;10MG | TABLET / ORAL | 2008-10-20 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090177-001 | OXYCODONE AND ACETAMINOPHEN | 325MG;2.5MG | TABLET / ORAL | 2008-10-20 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090177-002 | OXYCODONE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | 2008-10-20 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090177-003 | OXYCODONE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | 2008-10-20 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090177-004 | OXYCODONE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | 2008-10-20 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090177-005 | OXYCODONE AND ACETAMINOPHEN | 500MG;7.5MG | TABLET / ORAL | 2008-10-20 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090177-006 | OXYCODONE AND ACETAMINOPHEN | 650MG;10MG | TABLET / ORAL | 2008-10-20 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090177-001 | OXYCODONE AND ACETAMINOPHEN | 325MG;2.5MG | TABLET / ORAL | 2008-10-20 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090177-002 | OXYCODONE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | 2008-10-20 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090177-003 | OXYCODONE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | 2008-10-20 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090177-004 | OXYCODONE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | 2008-10-20 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090177-005 | OXYCODONE AND ACETAMINOPHEN | 500MG;7.5MG | TABLET / ORAL | 2008-10-20 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090177-006 | OXYCODONE AND ACETAMINOPHEN | 650MG;10MG | TABLET / ORAL | 2008-10-20 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090177-001 | OXYCODONE AND ACETAMINOPHEN | 325MG;2.5MG | TABLET / ORAL | 2008-10-20 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090177-002 | OXYCODONE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | 2008-10-20 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090177-003 | OXYCODONE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | 2008-10-20 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090177-004 | OXYCODONE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | 2008-10-20 | 2680178bc6a6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090177-001 | AA | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090177-002 | AA | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090177-003 | AA | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090177-004 | AA | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A090177-001 | AA | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A090177-002 | AA | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A090177-003 | AA | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A090177-004 | AA | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A090177-001 | AA | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A090177-002 | AA | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A090177-003 | AA | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A090177-004 | AA | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A090177-001 | AA | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A090177-002 | AA | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A090177-003 | AA | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A090177-004 | AA | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A090177-001 | AA | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A090177-002 | AA | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A090177-003 | AA | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A090177-004 | AA | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A090177-001 | AA | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A090177-002 | AA | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A090177-003 | AA | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A090177-004 | AA | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A090177-001 | AA | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A090177-002 | AA | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A090177-003 | AA | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A090177-004 | AA | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A090177-001 | AA | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A090177-002 | AA | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A090177-003 | AA | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A090177-004 | AA | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A090177-001 | AA | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A090177-002 | AA | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A090177-003 | AA | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A090177-004 | AA | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A090177-001 | AA | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A090177-002 | AA | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A090177-003 | AA | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A090177-004 | AA | 1 | c0c555d07b60… |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 67296-1401-1 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-374f-a426-e053-dadaa90af4c2 | 50d3a17f-34ed-219f-e054-00144ff88e88 |
| 67296-1401-6 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-374f-a426-e053-dadaa90af4c2 | 50d3a17f-34ed-219f-e054-00144ff88e88 |
| 67296-1401-8 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-374f-a426-e053-dadaa90af4c2 | 50d3a17f-34ed-219f-e054-00144ff88e88 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 67296-1401-1 | Oxycodone and Acetaminophen | 10 in 1 BOTTLE | TABLET | 10 | 3 | |
| 67296-1401-6 | Oxycodone and Acetaminophen | 6 in 1 BOTTLE | TABLET | 6 | 3 | |
| 67296-1401-8 | Oxycodone and Acetaminophen | 12 in 1 BOTTLE | TABLET | 12 | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 67296-1401 | OXYCODONE AND ACETAMINOPHEN TABLET [REDPHARM DRUG, INC.] | 3 | Legacy NDC, 3 package rows | 20200122_50d3a17f-34ed-219f-e054-00144ff88e88.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1049221 | oxyCODONE 5 MG / acetaminophen 325 MG Oral Tablet | PSN | 50d3a17f-34ed-219f-e054-00144ff88e88 | 3 |
| 1049221 | acetaminophen 325 MG / oxycodone hydrochloride 5 MG Oral Tablet | SCD | 50d3a17f-34ed-219f-e054-00144ff88e88 | 3 |
| 1049221 | APAP 325 MG / oxycodone hydrochloride 5 MG Oral Tablet | SY | 50d3a17f-34ed-219f-e054-00144ff88e88 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 67296-1401-8 | 67296140108 | 12 TABLET in 1 BOTTLE (67296-1401-8) | 12 tablet | 2008-12-16 | 0000-00-00 | No | No | Current |