Oxycodone Hydrochloride
- Product NDC
- 68071-2899
- 11-digit product format
- 680712899
- Labeler code
- 68071
- Product ID
- 68071-2899_217adc8e-b886-1fdb-e063-6294a90a26fa
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Oxycodone Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA091490
- Marketing category
- ANDA
- Marketing start
- 2014-09-08
- 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
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A091490-001 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2011-03-09 | |
| A091490-002 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2011-03-09 | |
| A091490-003 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2011-03-09 | |
| A091490-004 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2011-03-09 | |
| A091490-005 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2011-03-09 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A091490-001 | AB |
| A091490-002 | AB |
| A091490-003 | AB |
| A091490-004 | AB |
| A091490-005 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A091490-001 | OXYCODONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2011-03-09 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A091490-002 | OXYCODONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2011-03-09 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A091490-003 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2011-03-09 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A091490-004 | OXYCODONE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2011-03-09 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A091490-005 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2011-03-09 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A091490-001 | OXYCODONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2011-03-09 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A091490-002 | OXYCODONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2011-03-09 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A091490-003 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2011-03-09 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A091490-004 | OXYCODONE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2011-03-09 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A091490-005 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2011-03-09 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091490-001 | OXYCODONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2011-03-09 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091490-002 | OXYCODONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2011-03-09 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091490-003 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2011-03-09 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091490-004 | OXYCODONE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2011-03-09 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091490-005 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2011-03-09 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A091490-001 | OXYCODONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2011-03-09 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A091490-002 | OXYCODONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2011-03-09 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A091490-003 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2011-03-09 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A091490-004 | OXYCODONE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2011-03-09 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A091490-005 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2011-03-09 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091490-001 | OXYCODONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2011-03-09 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091490-002 | OXYCODONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2011-03-09 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091490-003 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2011-03-09 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091490-004 | OXYCODONE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2011-03-09 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091490-005 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2011-03-09 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091490-001 | OXYCODONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2011-03-09 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091490-002 | OXYCODONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2011-03-09 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091490-003 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2011-03-09 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091490-004 | OXYCODONE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2011-03-09 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091490-005 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2011-03-09 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091490-001 | OXYCODONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2011-03-09 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091490-002 | OXYCODONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2011-03-09 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091490-003 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2011-03-09 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091490-004 | OXYCODONE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2011-03-09 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091490-005 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2011-03-09 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091490-001 | OXYCODONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2011-03-09 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091490-002 | OXYCODONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2011-03-09 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091490-003 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2011-03-09 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091490-004 | OXYCODONE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2011-03-09 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091490-005 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2011-03-09 | 2680178bc6a6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A091490-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A091490-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A091490-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A091490-004 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A091490-005 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A091490-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A091490-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A091490-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A091490-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A091490-005 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091490-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091490-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091490-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091490-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091490-005 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A091490-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A091490-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A091490-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A091490-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A091490-005 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091490-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091490-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091490-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091490-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091490-005 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091490-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091490-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091490-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091490-004 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091490-005 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091490-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091490-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091490-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091490-004 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091490-005 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091490-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091490-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091490-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091490-004 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091490-005 | AB | 1 | 2680178bc6a6… |
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 |
|---|---|
| ef58f422-682e-6896-e053-2a95a90a1f2d | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68071-2899-4 | Oxycodone Hydrochloride | 4 in 1 BOTTLE, PLASTIC | TABLET | 4 | 2 | |
| 68071-2899-6 | Oxycodone Hydrochloride | 6 in 1 BOTTLE, PLASTIC | TABLET | 6 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68071-2899 | OXYCODONE HYDROCHLORIDE TABLET [NUCARE PHARMACEUTICALS,INC.] | 2 | Current NDC, Legacy NDC, 2 package rows | 20240907_ef58f422-682e-6896-e053-2a95a90a1f2d.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 | Bryant Ranch Prepack | bb33bf7f-aa70-4e8a-91b2-4e0400dc328e | 2026-06-29 | Boxed warning, Warnings, Adverse reactions | 091490 ANDA091490 |
| Oxycodone Hydrochloride | OXYCODONE HYDROCHLORIDE | Bryant Ranch Prepack | 0e4dd113-87ab-4a5d-846a-446db3cfd469 | 2026-06-16 | Boxed warning, Warnings, Adverse reactions | 091490 ANDA091490 |
| Oxycodone Hydrochloride | OXYCODONE HYDROCHLORIDE | Rhodes Pharmaceuticals LLC | a5162476-1217-41c0-bc7e-0a0f123f069f | 2026-05-06 | Boxed warning, Warnings, Adverse reactions | 091490 ANDA091490 |
| Oxycodone Hydrochloride | OXYCODONE HYDROCHLORIDE | Bryant Ranch Prepack | 6de58d48-d6fc-46b4-ab7c-9ffdede855dc | 2026-04-14 | Boxed warning, Warnings, Adverse reactions | 091490 ANDA091490 |
| Oxycodone Hydrochloride | OXYCODONE HYDROCHLORIDE | Bryant Ranch Prepack | a1e539ba-2cb5-4815-8c58-37abfd978fa5 | 2026-04-07 | Boxed warning, Warnings, Adverse reactions | 091490 ANDA091490 |
| Oxycodone Hydrochloride | OXYCODONE HYDROCHLORIDE | Bryant Ranch Prepack | 7503ef9d-0fad-421f-951a-f35ab71f71c7 | 2026-04-07 | Boxed warning, Warnings, Adverse reactions | 091490 ANDA091490 |
| Oxycodone Hydrochloride | OXYCODONE HYDROCHLORIDE | Bryant Ranch Prepack | 22f9eeaa-8aad-44f6-8258-e41edb60f876 | 2026-04-07 | Boxed warning, Warnings, Adverse reactions | 091490 ANDA091490 |
| Oxycodone Hydrochloride | OXYCODONE HYDROCHLORIDE | Bryant Ranch Prepack | 1a190488-3444-43b0-b9c8-45c1eb371aad | 2026-03-27 | Boxed warning, Warnings, Adverse reactions | 091490 ANDA091490 |
| Oxycodone Hydrochloride | OXYCODONE HYDROCHLORIDE | Asclemed USA, Inc. | c10cc127-8756-4ddc-9f46-1e003ef271dc | 2025-01-08 | Boxed warning, Warnings, Adverse reactions | 091490 ANDA091490 |
| Oxycodone Hydrochloride | OXYCODONE HYDROCHLORIDE | Bryant Ranch Prepack | d9841f2d-d182-4888-9a3c-68e1afb3e19c | 2024-11-20 | Boxed warning, Warnings, Adverse reactions | 091490 ANDA091490 |
| Oxycodone Hydrochloride | OXYCODONE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | ef58f422-682e-6896-e053-2a95a90a1f2d | 2024-09-06 | Boxed warning, Warnings, Adverse reactions | 091490 ANDA091490 68071-2899 |
| Oxycodone Hydrochloride | OXYCODONE HYDROCHLORIDE | Bryant Ranch Prepack | 1bcddbe1-c453-43ec-a822-9e993b885a5f | 2024-08-27 | Boxed warning, Warnings, Adverse reactions | 091490 ANDA091490 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1049621 | oxyCODONE HCl 5 MG Oral Tablet | PSN | ef58f422-682e-6896-e053-2a95a90a1f2d | 2 |
| 1049621 | oxycodone hydrochloride 5 MG Oral Tablet | SCD | ef58f422-682e-6896-e053-2a95a90a1f2d | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 68071-2899-4 | 68071289904 | 4 TABLET in 1 BOTTLE, PLASTIC (68071-2899-4) | 4 tablet | 2022-12-08 | No | No | Current | |
| 68071-2899-6 | 68071289906 | 6 TABLET in 1 BOTTLE, PLASTIC (68071-2899-6) | 6 tablet | 2022-12-08 | 0000-00-00 | No | No | Current |