OXYCODONE HYDROCHLORIDE
- Product NDC
- 0406-0552
- Requested package NDC
- 0406-0552-23
- 11-digit product format
- 004060552
- Labeler code
- 0406
- Product ID
- 0406-0552_2b25e4bc-e02b-4fd0-a214-1da1b3fb5dd1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- oxycodone hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- SpecGx LLC
- Application
- ANDA076758
- Marketing category
- ANDA
- Marketing start
- 2004-06-30
- 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
- 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 |
|---|---|---|---|---|---|---|---|
| A076758-001 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2004-06-30 | |
| A076758-002 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2004-06-30 | |
| A076758-003 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2007-03-19 | |
| A076758-004 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2021-10-12 | |
| A076758-005 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2021-10-12 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A076758-001 | AB |
| A076758-002 | AB |
| A076758-003 | AB |
| A076758-004 | AB |
| A076758-005 | 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 | A076758-001 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2004-06-30 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A076758-002 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2004-06-30 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A076758-003 | OXYCODONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2007-03-19 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A076758-004 | OXYCODONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2021-10-12 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A076758-005 | OXYCODONE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2021-10-12 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A076758-001 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2004-06-30 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A076758-002 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2004-06-30 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A076758-003 | OXYCODONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2007-03-19 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A076758-004 | OXYCODONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2021-10-12 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A076758-005 | OXYCODONE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2021-10-12 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076758-001 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2004-06-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076758-002 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2004-06-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076758-003 | OXYCODONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2007-03-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076758-004 | OXYCODONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2021-10-12 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076758-005 | OXYCODONE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2021-10-12 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076758-001 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2004-06-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076758-002 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2004-06-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076758-003 | OXYCODONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2007-03-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076758-004 | OXYCODONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2021-10-12 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076758-005 | OXYCODONE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2021-10-12 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076758-001 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2004-06-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076758-002 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2004-06-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076758-003 | OXYCODONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2007-03-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076758-004 | OXYCODONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2021-10-12 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076758-005 | OXYCODONE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2021-10-12 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076758-001 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2004-06-30 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076758-002 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2004-06-30 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076758-003 | OXYCODONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2007-03-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076758-004 | OXYCODONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2021-10-12 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076758-005 | OXYCODONE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2021-10-12 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076758-001 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2004-06-30 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076758-002 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2004-06-30 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076758-003 | OXYCODONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2007-03-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076758-004 | OXYCODONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2021-10-12 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076758-005 | OXYCODONE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2021-10-12 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076758-001 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2004-06-30 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076758-002 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2004-06-30 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076758-003 | OXYCODONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2007-03-19 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076758-004 | OXYCODONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2021-10-12 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076758-005 | OXYCODONE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2021-10-12 | 03ed91905a0d… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A076758-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A076758-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A076758-003 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A076758-004 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A076758-005 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A076758-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A076758-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A076758-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A076758-004 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A076758-005 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A076758-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076758-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076758-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076758-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076758-005 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076758-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076758-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076758-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076758-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076758-005 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A076758-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076758-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076758-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076758-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076758-005 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076758-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076758-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076758-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076758-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076758-005 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076758-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076758-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076758-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076758-004 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076758-005 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076758-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076758-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076758-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076758-004 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076758-005 | AB | 1 | 03ed91905a0d… |
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 | 5 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| C1ENJ2TE6C | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 928227bf-89c5-4c64-9823-0e84cc669388 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0406-0552-01 | OXYCODONE HYDROCHLORIDE | 100 in 1 BOTTLE | TABLET | 100 | 35 | |
| 0406-0552-23 | OXYCODONE HYDROCHLORIDE | 1 in 1 BLISTER PACK | TABLET | 1 | 35 | |
| 0406-0552-62 | OXYCODONE HYDROCHLORIDE | 100 in 1 BLISTER PACK | TABLET | 100 | 35 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0406-0552-01 | EA - Each | 0406-0552 | d5f1d538-b2c5-42ab-9f85-c1430338abe1 | 1 | 2012-07-24 |
| 0406-0552-23 | EA - Each | 0406-0552 | 0feb26d5-16b7-49f1-9628-a1c109191a8a | 1 | 2013-03-03 |
| 0406-0552-62 | EA - Each | 0406-0552 | c6a85541-9165-43b9-9d68-1f17d1319ee9 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
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 | SpecGx LLC | 928227bf-89c5-4c64-9823-0e84cc669388 | 2026-08-07 | Boxed warning, Warnings, Adverse reactions | 076758 ANDA076758 0406-0552-23 0406-0552 00406055223 |
| OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | Redpharm Drug | 5301d432-7fca-2d72-e063-6394a90a18a4 | 2026-05-30 | Boxed warning, Warnings, Adverse reactions | 076758 ANDA076758 |
| OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | RedPharm Drug, Inc. | 92614a3a-331d-16ad-e053-2a95a90a47cc | 2025-04-09 | Boxed warning, Warnings, Adverse reactions | 076758 ANDA076758 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1049683 | oxyCODONE HCl 10 MG Oral Tablet | PSN | 928227bf-89c5-4c64-9823-0e84cc669388 | 35 |
| 1049611 | oxyCODONE HCl 15 MG Oral Tablet | PSN | 928227bf-89c5-4c64-9823-0e84cc669388 | 35 |
| 1049686 | oxyCODONE HCl 20 MG Oral Tablet | PSN | 928227bf-89c5-4c64-9823-0e84cc669388 | 35 |
| 1049618 | oxyCODONE HCl 30 MG Oral Tablet | PSN | 928227bf-89c5-4c64-9823-0e84cc669388 | 35 |
| 1049621 | oxyCODONE HCl 5 MG Oral Tablet | PSN | 928227bf-89c5-4c64-9823-0e84cc669388 | 35 |
| 1049683 | oxycodone hydrochloride 10 MG Oral Tablet | SCD | 928227bf-89c5-4c64-9823-0e84cc669388 | 35 |
| 1049611 | oxycodone hydrochloride 15 MG Oral Tablet | SCD | 928227bf-89c5-4c64-9823-0e84cc669388 | 35 |
| 1049686 | oxycodone hydrochloride 20 MG Oral Tablet | SCD | 928227bf-89c5-4c64-9823-0e84cc669388 | 35 |
| 1049618 | oxycodone hydrochloride 30 MG Oral Tablet | SCD | 928227bf-89c5-4c64-9823-0e84cc669388 | 35 |
| 1049621 | oxycodone hydrochloride 5 MG Oral Tablet | SCD | 928227bf-89c5-4c64-9823-0e84cc669388 | 35 |
| 1049621 | oxyCODONE HCl 5 MG Oral Tablet | PSN | 92614a3a-331d-16ad-e053-2a95a90a47cc | 15 |
| 1049621 | oxycodone hydrochloride 5 MG Oral Tablet | SCD | 92614a3a-331d-16ad-e053-2a95a90a47cc | 15 |
| 1049621 | oxyCODONE HCl 5 MG Oral Tablet | PSN | 5301d432-7fca-2d72-e063-6394a90a18a4 | 1 |
| 1049621 | oxyCODONE HCl 5 MG Oral Tablet | PSN | 444d5f08-e491-4ff7-bf35-c26ae972f3ff | 1 |
| 1049621 | oxyCODONE HCl 5 MG Oral Tablet | PSN | 25c2a91c-dfc2-4596-8a24-63acf04a2568 | 1 |
| 1049621 | oxycodone hydrochloride 5 MG Oral Tablet | SCD | 25c2a91c-dfc2-4596-8a24-63acf04a2568 | 1 |
| 1049621 | oxycodone hydrochloride 5 MG Oral Tablet | SCD | 5301d432-7fca-2d72-e063-6394a90a18a4 | 1 |
| 1049621 | oxycodone hydrochloride 5 MG Oral Tablet | SCD | 444d5f08-e491-4ff7-bf35-c26ae972f3ff | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0406-0552-23 | 00406055223 | 1 TABLET in 1 BLISTER PACK (0406-0552-23) | 1 tablet | 2004-06-30 | 0000-00-00 | No | No | Current |