Oxycodone Hydrochloride
- Product NDC
- 0904-6590
- 11-digit product format
- 009046590
- Labeler code
- 0904
- Product ID
- 0904-6590_3b973e31-c79c-4615-9bcd-9df008928f6e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Oxycodone Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA077712
- Marketing category
- ANDA
- Marketing start
- 2015-04-13
- Marketing end
- 2020-02-29
- 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
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 0904-6590 | D | Discontinued by firm | 2026-08-03 | ||
| excluded package | package | 0904-6590 | 0904-6590-61 | D | Discontinued by firm | 2026-08-03 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A077712-001 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2007-01-31 | |
| A077712-002 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2007-01-31 | |
| A077712-003 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2009-03-02 | |
| A077712-004 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2015-04-13 | |
| A077712-005 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2015-04-13 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A077712-001 | AB |
| A077712-002 | AB |
| A077712-003 | AB |
| A077712-004 | AB |
| A077712-005 | 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 | A077712-001 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2007-01-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077712-002 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2007-01-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077712-003 | OXYCODONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2009-03-02 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077712-004 | OXYCODONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2015-04-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077712-005 | OXYCODONE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2015-04-13 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077712-001 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2007-01-31 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077712-002 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2007-01-31 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077712-003 | OXYCODONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2009-03-02 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077712-004 | OXYCODONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2015-04-13 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077712-005 | OXYCODONE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2015-04-13 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077712-001 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2007-01-31 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077712-002 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2007-01-31 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077712-003 | OXYCODONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2009-03-02 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077712-004 | OXYCODONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2015-04-13 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077712-005 | OXYCODONE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2015-04-13 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077712-001 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2007-01-31 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077712-002 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2007-01-31 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077712-003 | OXYCODONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2009-03-02 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077712-004 | OXYCODONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2015-04-13 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077712-005 | OXYCODONE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2015-04-13 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077712-001 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2007-01-31 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077712-002 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2007-01-31 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077712-003 | OXYCODONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2009-03-02 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077712-004 | OXYCODONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2015-04-13 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077712-005 | OXYCODONE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2015-04-13 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077712-001 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2007-01-31 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077712-002 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2007-01-31 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077712-003 | OXYCODONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2009-03-02 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077712-004 | OXYCODONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2015-04-13 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077712-005 | OXYCODONE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2015-04-13 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077712-001 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2007-01-31 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077712-002 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2007-01-31 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077712-003 | OXYCODONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2009-03-02 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077712-004 | OXYCODONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2015-04-13 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077712-005 | OXYCODONE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2015-04-13 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077712-001 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2007-01-31 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077712-002 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2007-01-31 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077712-003 | OXYCODONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2009-03-02 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077712-004 | OXYCODONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2015-04-13 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077712-005 | OXYCODONE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2015-04-13 | 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 | A077712-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077712-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077712-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077712-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077712-005 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077712-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077712-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077712-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077712-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077712-005 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A077712-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077712-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077712-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077712-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077712-005 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077712-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077712-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077712-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077712-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077712-005 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077712-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077712-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077712-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077712-004 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077712-005 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077712-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077712-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077712-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077712-004 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077712-005 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077712-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077712-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077712-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077712-004 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077712-005 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077712-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077712-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077712-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077712-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077712-005 | AB | 1 | 5bbf6a4d5a75… |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Oxycodone Hydrochloride | OXYCODONE HYDROCHLORIDE | Strides Pharma Science Limited | f3116ebf-d72c-4e98-aa50-006be4770c86 | 2026-01-09 | Boxed warning, Warnings, Adverse reactions | 077712 ANDA077712 |
| Oxycodone Hydrochloride | OXYCODONE HYDROCHLORIDE | Asclemed USA, Inc. | 056bdaac-4a43-42f0-9435-f349d3ccc128 | 2025-12-27 | Boxed warning, Warnings, Adverse reactions | 077712 ANDA077712 |
| Oxycodone Hydrochloride | OXYCODONE HYDROCHLORIDE | Redpharm Drug | 439c2de6-3ea5-e829-e063-6294a90aa77d | 2025-12-02 | Boxed warning, Warnings, Adverse reactions | 077712 ANDA077712 |
| Oxycodone Hydrochloride | OXYCODONE HYDROCHLORIDE | Bryant Ranch Prepack | 08977126-9671-4d87-9724-1599ca86e181 | 2025-10-16 | Boxed warning, Warnings, Adverse reactions | 077712 ANDA077712 |
| Oxycodone Hydrochloride | OXYCODONE HYDROCHLORIDE | ST. MARY'S MEDICAL PARK PHARMACY | 3ca9f0d9-a40d-4416-e063-6394a90aec8b | 2025-08-18 | Boxed warning, Warnings, Adverse reactions | 077712 ANDA077712 |
| Oxycodone HCL | OXYCODONE HCL | Direct_Rx | 3245cd2f-8ad0-b755-e063-6394a90a603c | 2025-07-22 | Boxed warning, Warnings, Adverse reactions | 077712 ANDA077712 |
| Oxycodone HCL | OXYCODONE HCL | Direct_Rx | 3a849aeb-b72c-5cde-e063-6394a90a9768 | 2025-07-22 | Boxed warning, Warnings, Adverse reactions | 077712 ANDA077712 |
| Oxycodone HCL | OXYCODONE HCL | Direct_Rx | 32323565-5add-96a9-e063-6294a90a5b4e | 2025-04-08 | Boxed warning, Warnings, Adverse reactions | 077712 ANDA077712 |
| Oxycodone HCL | OXYCODONE HCL | Direct_Rx | 323148b2-809a-db11-e063-6294a90abe36 | 2025-04-07 | Boxed warning, Warnings, Adverse reactions | 077712 ANDA077712 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0904-6590-61 | EA - Each | 0904-6590 | 936d94c2-b6a8-49c9-abc6-c6597b372b9e | 1 | 2017-09-11 |