Oxycodone Hydrochloride
- Product NDC
- 71335-1101
- 11-digit product format
- 713351101
- Labeler code
- 71335
- Product ID
- 71335-1101_3ddf2537-9837-4432-a80e-33a751f11a6b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Oxycodone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA203638
- Marketing category
- ANDA
- Marketing start
- 2012-10-30
- Marketing end
- 0000-00-00
- Substance
- OXYCODONE HYDROCHLORIDE
- Active strength
- 10 mg/1
- Pharmacologic classes
- Full Opioid Agonists [MoA],Opioid Agonist [EPC]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A203638-001 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2014-06-03 | |
| A203638-002 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-06-03 | |
| A203638-003 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2014-06-03 | |
| A203638-004 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2014-06-03 | |
| A203638-005 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2014-06-03 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A203638-001 | AB |
| A203638-002 | AB |
| A203638-003 | AB |
| A203638-004 | AB |
| A203638-005 | 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 | A203638-001 | OXYCODONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2014-06-03 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A203638-002 | OXYCODONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-06-03 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A203638-003 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2014-06-03 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A203638-004 | OXYCODONE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2014-06-03 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A203638-005 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2014-06-03 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203638-001 | OXYCODONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2014-06-03 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203638-002 | OXYCODONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-06-03 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203638-003 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2014-06-03 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203638-004 | OXYCODONE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2014-06-03 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203638-005 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2014-06-03 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203638-001 | OXYCODONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2014-06-03 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203638-002 | OXYCODONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-06-03 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203638-003 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2014-06-03 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203638-004 | OXYCODONE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2014-06-03 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203638-005 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2014-06-03 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203638-001 | OXYCODONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2014-06-03 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203638-002 | OXYCODONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-06-03 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203638-003 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2014-06-03 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203638-004 | OXYCODONE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2014-06-03 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203638-005 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2014-06-03 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203638-001 | OXYCODONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2014-06-03 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203638-002 | OXYCODONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-06-03 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203638-003 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2014-06-03 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203638-004 | OXYCODONE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2014-06-03 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203638-005 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2014-06-03 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203638-001 | OXYCODONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2014-06-03 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203638-002 | OXYCODONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-06-03 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203638-003 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2014-06-03 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203638-004 | OXYCODONE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2014-06-03 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203638-005 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2014-06-03 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203638-001 | OXYCODONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2014-06-03 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203638-002 | OXYCODONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-06-03 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203638-003 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2014-06-03 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203638-004 | OXYCODONE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2014-06-03 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203638-005 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2014-06-03 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203638-001 | OXYCODONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2014-06-03 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203638-002 | OXYCODONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-06-03 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203638-003 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2014-06-03 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203638-004 | OXYCODONE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2014-06-03 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203638-005 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2014-06-03 | 5bbf6a4d5a75… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A203638-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A203638-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A203638-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A203638-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A203638-005 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203638-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203638-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203638-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203638-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203638-005 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A203638-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A203638-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A203638-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A203638-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A203638-005 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203638-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203638-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203638-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203638-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203638-005 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203638-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203638-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203638-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203638-004 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203638-005 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203638-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203638-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203638-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203638-004 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203638-005 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203638-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203638-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203638-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203638-004 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203638-005 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203638-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203638-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203638-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203638-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203638-005 | AB | 1 | 5bbf6a4d5a75… |
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 | Major Pharmaceuticals | 6b6db42b-9821-4aa6-8566-297037d84079 | 2026-07-23 | Boxed warning, Warnings, Adverse reactions | 203638 ANDA203638 |
| Oxycodone Hydrochloride | OXYCODONE | Amneal Pharmaceuticals LLC | 094b64b3-cd32-4de5-afb6-ea00d9caad74 | 2026-06-23 | Boxed warning, Warnings, Adverse reactions | 203638 ANDA203638 |
| Oxycodone Hydrochloride | OXYCODONE | Redpharm Drug | 525001a6-68d8-7ef7-e063-6294a90abc5f | 2026-05-21 | Boxed warning, Warnings, Adverse reactions | 203638 ANDA203638 |
| Oxycodone Hydrochloride | OXYCODONE HYDROCHLORIDE | Precision Dose, Inc. | f849c7cc-fa85-47eb-be30-1be137913bf9 | 2024-12-17 | Boxed warning, Warnings, Adverse reactions | 203638 ANDA203638 |
| Oxycodone Hydrochloride | OXYCODONE | Bryant Ranch Prepack | b2510d72-bf63-4c9d-ac5e-7bacd993fa10 | 2024-05-30 | Boxed warning, Warnings, Adverse reactions | 203638 ANDA203638 |
| Oxycodone Hydrochloride | OXYCODONE | Bryant Ranch Prepack | 232d44d2-3924-4d35-873c-d2aef75e9a41 | 2024-05-30 | Boxed warning, Warnings, Adverse reactions | 203638 ANDA203638 |
| Oxycodone Hydrochloride | OXYCODONE | Bryant Ranch Prepack | d248ceba-9492-4348-aa07-31c9c73a3620 | 2024-05-30 | Boxed warning, Warnings, Adverse reactions | 203638 ANDA203638 |
| Oxycodone Hydrochloride | OXYCODONE | Bryant Ranch Prepack | bc7fdf7e-ad4e-4a04-b35c-2233cc7e5f15 | 2024-05-30 | Boxed warning, Warnings, Adverse reactions | 203638 ANDA203638 |
| Oxycodone Hydrochloride | OXYCODONE | Bryant Ranch Prepack | 4e9e945d-5ffc-48de-99fa-3fb36c5bc2b9 | 2024-05-30 | Boxed warning, Warnings, Adverse reactions | 203638 ANDA203638 |
| Oxycodone Hydrochloride | OXYCODONE | Bryant Ranch Prepack | 9da42120-0214-45cb-bb98-9a7739e72d43 | 2024-05-29 | Boxed warning, Warnings, Adverse reactions | 203638 ANDA203638 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 71335-1101-1 | 71335110101 | 120 TABLET in 1 BOTTLE (71335-1101-1) | 120 tablet | 2019-02-14 | 0000-00-00 | No | No | Current |
| 71335-1101-2 | 71335110102 | 30 TABLET in 1 BOTTLE (71335-1101-2) | 30 tablet | 2019-02-14 | 0000-00-00 | No | No | Current |
| 71335-1101-3 | 71335110103 | 60 TABLET in 1 BOTTLE (71335-1101-3) | 60 tablet | 2019-02-14 | 0000-00-00 | No | No | Current |
| 71335-1101-4 | 71335110104 | 90 TABLET in 1 BOTTLE (71335-1101-4) | 90 tablet | 2019-02-14 | 0000-00-00 | No | No | Current |
| 71335-1101-5 | 71335110105 | 40 TABLET in 1 BOTTLE (71335-1101-5) | 40 tablet | 2019-02-14 | 0000-00-00 | No | No | Current |
| 71335-1101-6 | 71335110106 | 28 TABLET in 1 BOTTLE (71335-1101-6) | 28 tablet | 2019-02-14 | 0000-00-00 | No | No | Current |