Oxycodone Hydrochloride
- Product NDC
- 71335-1361
- 11-digit product format
- 713351361
- Labeler code
- 71335
- Product ID
- 71335-1361_54e9825a-c175-412a-911d-0930609a5c9e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Oxycodone Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA202160
- Marketing category
- ANDA
- Marketing start
- 2012-07-12
- Substance
- OXYCODONE HYDROCHLORIDE
- Active strength
- 5 mg/1
- Pharmacologic classes
- Full Opioid Agonists [MoA], Opioid Agonist [EPC]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
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 | Product NDC | Package NDC | Code | Status | Reporting period | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 71335-1361 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 557ba5c1ecfa… | 9c80585c8c6e… | ||
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 71335-1361 | 71335-1361-9 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 71335-1361 | 71335-1361-8 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 71335-1361 | 71335-1361-4 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 71335-1361 | 71335-1361-6 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 71335-1361 | 71335-1361-1 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 71335-1361 | 71335-1361-3 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 71335-1361 | 71335-1361-7 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 71335-1361 | 71335-1361-2 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 71335-1361 | 71335-1361-5 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded product | product | 71335-1361 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 8af77b9d5b6f… | d9bbb34c5368… | ||
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 71335-1361 | 71335-1361-9 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 8af77b9d5b6f… | d9bbb34c5368… | |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 71335-1361 | 71335-1361-8 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 8af77b9d5b6f… | d9bbb34c5368… | |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 71335-1361 | 71335-1361-4 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 8af77b9d5b6f… | d9bbb34c5368… | |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 71335-1361 | 71335-1361-6 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 8af77b9d5b6f… | d9bbb34c5368… | |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 71335-1361 | 71335-1361-1 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 8af77b9d5b6f… | d9bbb34c5368… | |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 71335-1361 | 71335-1361-3 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 8af77b9d5b6f… | d9bbb34c5368… | |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 71335-1361 | 71335-1361-7 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 8af77b9d5b6f… | d9bbb34c5368… | |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 71335-1361 | 71335-1361-2 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 8af77b9d5b6f… | d9bbb34c5368… | |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 71335-1361 | 71335-1361-5 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 8af77b9d5b6f… | d9bbb34c5368… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded product | product | 71335-1361 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 834df4deac94… | adcc014656a3… | ||
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 71335-1361 | 71335-1361-9 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 834df4deac94… | adcc014656a3… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 71335-1361 | 71335-1361-8 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 834df4deac94… | adcc014656a3… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 71335-1361 | 71335-1361-4 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 834df4deac94… | adcc014656a3… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 71335-1361 | 71335-1361-6 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 834df4deac94… | adcc014656a3… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 71335-1361 | 71335-1361-1 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 834df4deac94… | adcc014656a3… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 71335-1361 | 71335-1361-3 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 834df4deac94… | adcc014656a3… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 71335-1361 | 71335-1361-7 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 834df4deac94… | adcc014656a3… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 71335-1361 | 71335-1361-2 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 834df4deac94… | adcc014656a3… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 71335-1361 | 71335-1361-5 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 834df4deac94… | adcc014656a3… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded product | product | 71335-1361 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 1332a3947898… | d4bfe170f9cd… | ||
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 71335-1361 | 71335-1361-9 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 1332a3947898… | d4bfe170f9cd… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 71335-1361 | 71335-1361-8 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 1332a3947898… | d4bfe170f9cd… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 71335-1361 | 71335-1361-4 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 1332a3947898… | d4bfe170f9cd… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 71335-1361 | 71335-1361-6 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 1332a3947898… | d4bfe170f9cd… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 71335-1361 | 71335-1361-1 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 1332a3947898… | d4bfe170f9cd… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 71335-1361 | 71335-1361-3 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 1332a3947898… | d4bfe170f9cd… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 71335-1361 | 71335-1361-7 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 1332a3947898… | d4bfe170f9cd… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 71335-1361 | 71335-1361-2 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 1332a3947898… | d4bfe170f9cd… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 71335-1361 | 71335-1361-5 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 1332a3947898… | d4bfe170f9cd… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A202160-001 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2012-11-19 | |
| A202160-002 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2012-11-19 | |
| A202160-003 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2012-11-19 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A202160-001 | AB |
| A202160-002 | AB |
| A202160-003 | AB |
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 | A202160-001 | OXYCODONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2012-11-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202160-002 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2012-11-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202160-003 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2012-11-19 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202160-001 | OXYCODONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2012-11-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202160-002 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2012-11-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202160-003 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2012-11-19 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202160-001 | OXYCODONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2012-11-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202160-002 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2012-11-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202160-003 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2012-11-19 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202160-001 | OXYCODONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2012-11-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202160-002 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2012-11-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202160-003 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2012-11-19 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202160-001 | OXYCODONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2012-11-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202160-002 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2012-11-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202160-003 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2012-11-19 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202160-001 | OXYCODONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2012-11-19 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202160-002 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2012-11-19 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202160-003 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2012-11-19 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202160-001 | OXYCODONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2012-11-19 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202160-002 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2012-11-19 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202160-003 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2012-11-19 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202160-001 | OXYCODONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2012-11-19 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202160-002 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2012-11-19 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202160-003 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2012-11-19 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202160-001 | OXYCODONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2012-11-19 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202160-002 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2012-11-19 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202160-003 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2012-11-19 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A202160-001 | OXYCODONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2012-11-19 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A202160-002 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2012-11-19 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A202160-003 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2012-11-19 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202160-001 | OXYCODONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2012-11-19 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202160-002 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2012-11-19 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202160-003 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2012-11-19 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202160-001 | OXYCODONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2012-11-19 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202160-002 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2012-11-19 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202160-003 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2012-11-19 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202160-001 | OXYCODONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2012-11-19 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202160-002 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2012-11-19 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202160-003 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2012-11-19 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A202160-001 | OXYCODONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2012-11-19 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A202160-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202160-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202160-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202160-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202160-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202160-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A202160-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202160-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202160-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202160-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202160-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202160-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202160-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202160-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202160-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202160-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202160-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202160-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202160-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202160-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202160-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202160-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202160-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202160-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202160-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202160-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202160-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A202160-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A202160-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A202160-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202160-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202160-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202160-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202160-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202160-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202160-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202160-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202160-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202160-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A202160-001 | AB | 1 | 8072bd15b7f6… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Oxycodone Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| OXYCODONE HYDROCHLORIDE | 5 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| C1ENJ2TE6C | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1049621 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 261132f9-ab96-4901-a660-a80c3e0f9d86 | Available on FDA.report |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 71335-1361-0 | Oxycodone Hydrochloride | 15 in 1 BOTTLE | TABLET | 15 | 3 | |
| 71335-1361-1 | Oxycodone Hydrochloride | 30 in 1 BOTTLE | TABLET | 30 | 3 | |
| 71335-1361-2 | Oxycodone Hydrochloride | 60 in 1 BOTTLE | TABLET | 60 | 3 | |
| 71335-1361-3 | Oxycodone Hydrochloride | 90 in 1 BOTTLE | TABLET | 90 | 3 | |
| 71335-1361-4 | Oxycodone Hydrochloride | 56 in 1 BOTTLE | TABLET | 56 | 3 | |
| 71335-1361-5 | Oxycodone Hydrochloride | 100 in 1 BOTTLE | TABLET | 100 | 3 | |
| 71335-1361-6 | Oxycodone Hydrochloride | 120 in 1 BOTTLE | TABLET | 120 | 3 | |
| 71335-1361-7 | Oxycodone Hydrochloride | 50 in 1 BOTTLE | TABLET | 50 | 3 | |
| 71335-1361-8 | Oxycodone Hydrochloride | 40 in 1 BOTTLE | TABLET | 40 | 3 | |
| 71335-1361-9 | Oxycodone Hydrochloride | 20 in 1 BOTTLE | TABLET | 20 | 3 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 71335-1361-2 | EA - Each | 71335-1361 | 169c71cb-6363-4233-b306-3796f1df59f3 | 1 | 2025-09-12 |
| 71335-1361-3 | EA - Each | 71335-1361 | 4a55d7e4-e4f7-44e9-91f4-550c2c4c98ab | 1 | 2025-09-12 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 71335-1361 | OXYCODONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK] | 3 | Current NDC, Legacy NDC, 10 package rows | 20240823_261132f9-ab96-4901-a660-a80c3e0f9d86.zip |
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 |
|---|---|---|---|---|---|---|
| Oxycodone Hydrochloride | OXYCODONE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | bdade691-3687-3308-e053-2995a90ad6ed | 2026-02-20 | Boxed warning, Warnings, Adverse reactions | 202160 ANDA202160 |
| Oxycodone Hydrochloride | OXYCODONE HYDROCHLORIDE | Aurolife Pharma, LLC | 96ad4352-fff3-46a7-85de-466cc161045e | 2025-12-23 | Boxed warning, Warnings, Adverse reactions | 202160 ANDA202160 |
| Oxycodone Hydrochloride | OXYCODONE HYDROCHLORIDE | Bryant Ranch Prepack | 261132f9-ab96-4901-a660-a80c3e0f9d86 | 2024-08-12 | Boxed warning, Warnings, Adverse reactions | 202160 ANDA202160 71335-1361 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1049621 | oxyCODONE HCl 5 MG Oral Tablet | PSN | 261132f9-ab96-4901-a660-a80c3e0f9d86 | 3 |
| 1049621 | oxycodone hydrochloride 5 MG Oral Tablet | SCD | 261132f9-ab96-4901-a660-a80c3e0f9d86 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 71335-1361-0 | 71335136100 | 15 TABLET in 1 BOTTLE (71335-1361-0) | 15 tablet | 2024-08-12 | No | No | Current | |
| 71335-1361-1 | 71335136101 | 30 TABLET in 1 BOTTLE (71335-1361-1) | 30 tablet | 2019-11-19 | 0000-00-00 | No | No | Current |
| 71335-1361-2 | 71335136102 | 60 TABLET in 1 BOTTLE (71335-1361-2) | 60 tablet | 2019-10-01 | 0000-00-00 | No | No | Current |
| 71335-1361-3 | 71335136103 | 90 TABLET in 1 BOTTLE (71335-1361-3) | 90 tablet | 2019-10-01 | 0000-00-00 | No | No | Current |
| 71335-1361-4 | 71335136104 | 56 TABLET in 1 BOTTLE (71335-1361-4) | 56 tablet | 2024-08-12 | 0000-00-00 | No | No | Current |
| 71335-1361-5 | 71335136105 | 100 TABLET in 1 BOTTLE (71335-1361-5) | 100 tablet | 2024-08-12 | 0000-00-00 | No | No | Current |
| 71335-1361-6 | 71335136106 | 120 TABLET in 1 BOTTLE (71335-1361-6) | 120 tablet | 2024-08-12 | 0000-00-00 | No | No | Current |
| 71335-1361-7 | 71335136107 | 50 TABLET in 1 BOTTLE (71335-1361-7) | 50 tablet | 2024-08-12 | 0000-00-00 | No | No | Current |
| 71335-1361-8 | 71335136108 | 40 TABLET in 1 BOTTLE (71335-1361-8) | 40 tablet | 2024-08-12 | 0000-00-00 | No | No | Current |
| 71335-1361-9 | 71335136109 | 20 TABLET in 1 BOTTLE (71335-1361-9) | 20 tablet | 2019-10-18 | 0000-00-00 | No | No | Current |