Oxycodone Hydrochloride
- Product NDC
- 68094-005
- 11-digit product format
- 680940005
- Labeler code
- 68094
- Product ID
- 68094-005_31203769-a951-4d0c-8d60-4cb7715e26e8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Oxycodone Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Precision Dose, Inc.
- Application
- ANDA203638
- Marketing category
- ANDA
- Marketing start
- 2016-12-21
- Substance
- OXYCODONE HYDROCHLORIDE
- Active strength
- 15 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
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… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Oxycodone Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| OXYCODONE HYDROCHLORIDE | 15 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| C1ENJ2TE6C | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1049611 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| f849c7cc-fa85-47eb-be30-1be137913bf9 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68094-005-59 | Oxycodone Hydrochloride | 10 in 1 BLISTER PACK | TABLET | 10 | 7 | |
| 68094-005-61 | Oxycodone Hydrochloride | 10 in 1 CARTON | TABLET | 10 | 7 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68094-005-59 | EA - Each | 68094-005 | afba1f95-14ac-469f-9521-13892cd1a5cb | 1 | 2018-02-20 |
| 68094-005-61 | EA - Each | 68094-005 | b13b545b-fa08-4135-a865-c32a4abb8864 | 1 | 2017-03-06 |
DailyMed Dashboard NDC Coverage#
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 68094-005 |
| 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 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1049611 | oxyCODONE HCl 15 MG Oral Tablet | PSN | f849c7cc-fa85-47eb-be30-1be137913bf9 | 7 |
| 1049611 | oxycodone hydrochloride 15 MG Oral Tablet | SCD | f849c7cc-fa85-47eb-be30-1be137913bf9 | 7 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 68094-005-59 | 68094000559 | 10 in 1 BLISTER PACK | Historical | |||||
| 68094-005-61 | 68094000561 | 10 BLISTER PACK in 1 CARTON (68094-005-61) / 10 TABLET in 1 BLISTER PACK (68094-005-59) | 10 blister pack | 2016-12-21 | 0000-00-00 | No | No | Current |