Oxycodone Hydrochloride
- Product NDC
- 60760-967
- 11-digit product format
- 607600967
- Labeler code
- 60760
- Product ID
- 60760-967_585405bc-8b86-286f-e063-6394a90aa5cd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Oxycodone Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- St. Mary's Medical Park Pharmacy
- Application
- ANDA207418
- Marketing category
- ANDA
- Marketing start
- 2026-08-06
- 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
- 2027-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A207418-001 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2017-08-07 | |
| A207418-002 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2017-08-07 | |
| A207418-003 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2025-11-14 | |
| A207418-004 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2025-11-14 | |
| A207418-005 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2025-11-14 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A207418-001 | AB |
| A207418-002 | AB |
| A207418-003 | AB |
| A207418-004 | AB |
| A207418-005 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A207418-001 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2017-08-07 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A207418-002 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2017-08-07 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A207418-003 | OXYCODONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2025-11-14 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A207418-004 | OXYCODONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2025-11-14 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A207418-005 | OXYCODONE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2025-11-14 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A207418-001 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2017-08-07 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A207418-002 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2017-08-07 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A207418-003 | OXYCODONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2025-11-14 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A207418-004 | OXYCODONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2025-11-14 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A207418-005 | OXYCODONE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2025-11-14 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A207418-001 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2017-08-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A207418-002 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2017-08-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A207418-003 | OXYCODONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2025-11-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A207418-004 | OXYCODONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2025-11-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A207418-005 | OXYCODONE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2025-11-14 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207418-001 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2017-08-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207418-002 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2017-08-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207418-003 | OXYCODONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2025-11-14 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207418-004 | OXYCODONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2025-11-14 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207418-005 | OXYCODONE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2025-11-14 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A207418-001 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2017-08-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A207418-002 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2017-08-07 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207418-001 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2017-08-07 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207418-002 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2017-08-07 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207418-001 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2017-08-07 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207418-002 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2017-08-07 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207418-001 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2017-08-07 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207418-002 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2017-08-07 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207418-001 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2017-08-07 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207418-002 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2017-08-07 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207418-001 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2017-08-07 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207418-002 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2017-08-07 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207418-001 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2017-08-07 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207418-002 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2017-08-07 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A207418-001 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2017-08-07 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A207418-002 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2017-08-07 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207418-001 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2017-08-07 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207418-002 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2017-08-07 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207418-001 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2017-08-07 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207418-002 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2017-08-07 | 301d65b070ca… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A207418-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A207418-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A207418-003 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A207418-004 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A207418-005 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A207418-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A207418-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A207418-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A207418-004 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A207418-005 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A207418-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A207418-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A207418-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A207418-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A207418-005 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207418-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207418-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207418-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207418-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207418-005 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A207418-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A207418-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207418-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207418-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207418-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207418-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207418-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207418-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207418-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207418-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207418-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207418-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207418-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207418-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A207418-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A207418-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207418-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207418-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207418-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207418-002 | AB | 1 | 301d65b070ca… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Oxycodone Hydrochloride
- Listing expiration
- 2027-12-31
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 |
|---|---|
| 585405bc-8b85-286f-e063-6394a90aa5cd | Available on FDA.report |
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 | St. Mary's Medical Park Pharmacy | 585405bc-8b85-286f-e063-6394a90aa5cd | 2026-08-06 | Boxed warning, Warnings, Adverse reactions | 207418 ANDA207418 60760-967 |
| Oxycodone Hydrochloride | OXYCODONE HYDROCHLORIDE | St. Mary's Medical Park Pharmacy | 57afed61-79db-ca43-e063-6394a90a68eb | 2026-07-24 | Boxed warning, Warnings, Adverse reactions | 207418 ANDA207418 |
| Oxycodone Hydrochloride | OXYCODONE HYDROCHLORIDE | Bryant Ranch Prepack | 27124cdf-a3e8-474c-9c1e-6fa48f6ddc05 | 2026-05-29 | Boxed warning, Warnings, Adverse reactions | 207418 ANDA207418 |
| Oxycodone Hydrochloride | OXYCODONE HYDROCHLORIDE | Bryant Ranch Prepack | ff7f1268-ddb7-4742-beee-8b12966fe8f9 | 2026-04-22 | Boxed warning, Warnings, Adverse reactions | 207418 ANDA207418 |
| Oxycodone Hydrochloride | OXYCODONE HYDROCHLORIDE | Bryant Ranch Prepack | 35030c55-47e6-44cb-9d96-0c3cd5d0c238 | 2026-03-24 | Boxed warning, Warnings, Adverse reactions | 207418 ANDA207418 |
| Oxycodone Hydrochloride | OXYCODONE HYDROCHLORIDE | Camber Pharmaceuticals Inc | 01db4606-d49c-4b10-a78a-1cf41880a9fb | 2026-01-14 | Boxed warning, Warnings, Adverse reactions | 207418 ANDA207418 |
| Oxycodone Hydrochloride | OXYCODONE HYDROCHLORIDE | XLCare Pharmaceuticals, Inc | e5c8e72d-4ac5-4ca3-9557-6a659d4d8338 | 2021-05-28 | Boxed warning, Warnings, Adverse reactions | 207418 ANDA207418 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 60760-967-30 | 60760096730 | 30 TABLET in 1 BOTTLE, PLASTIC (60760-967-30) | 30 tablet | 2026-08-06 | No | No | Current |
| 60760-967-60 | 60760096760 | 60 TABLET in 1 BOTTLE, PLASTIC (60760-967-60) | 60 tablet | 2026-08-06 | No | No | Current |