OXYCODONE AND ACETAMINOPHEN
- Product NDC
- 31722-948
- 11-digit product format
- 317220948
- Labeler code
- 31722
- Product ID
- 31722-948_77cf0bd6-7b1c-41ec-825b-0ffd86032537
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Oxycodone and Acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Camber Pharmaceuticals, Inc.
- Application
- ANDA207419
- Marketing category
- ANDA
- Marketing start
- 2017-04-11
- Substance
- ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
- Active strength
- 325; 2.5 mg/1; 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- OXYCODONE AND ACETAMINOPHEN
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 325 mg/1 |
| OXYCODONE HYDROCHLORIDE | 2.5 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 362O9ITL9D, C1ENJ2TE6C |
| Rxcui | 1049214, 1049221, 1049225, 1049635 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 31722-948-01 | OXYCODONE AND ACETAMINOPHEN | 100 in 1 BOTTLE | TABLET | 100 | 10 | |
| 31722-948-05 | OXYCODONE AND ACETAMINOPHEN | 500 in 1 BOTTLE | TABLET | 500 | 10 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 31722-948-01 | EA - Each | 31722-948 | 70fad90e-d3f2-46ca-bff8-6139a086f988 | 1 | 2019-04-11 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1049214 | oxyCODONE 10 MG / acetaminophen 325 MG Oral Tablet | PSN | 42777191-0454-4ccb-8fc3-8b18b0ee43f7 | 10 |
| 1049221 | oxyCODONE 5 MG / acetaminophen 325 MG Oral Tablet | PSN | 42777191-0454-4ccb-8fc3-8b18b0ee43f7 | 10 |
| 1049225 | oxyCODONE 7.5 MG / acetaminophen 325 MG Oral Tablet | PSN | 42777191-0454-4ccb-8fc3-8b18b0ee43f7 | 10 |
| 1049635 | oxyCODONE HCl 2.5 MG / acetaminophen 325 MG Oral Tablet | PSN | 42777191-0454-4ccb-8fc3-8b18b0ee43f7 | 10 |
| 1049214 | acetaminophen 325 MG / oxycodone hydrochloride 10 MG Oral Tablet | SCD | 42777191-0454-4ccb-8fc3-8b18b0ee43f7 | 10 |
| 1049635 | acetaminophen 325 MG / oxycodone hydrochloride 2.5 MG Oral Tablet | SCD | 42777191-0454-4ccb-8fc3-8b18b0ee43f7 | 10 |
| 1049221 | acetaminophen 325 MG / oxycodone hydrochloride 5 MG Oral Tablet | SCD | 42777191-0454-4ccb-8fc3-8b18b0ee43f7 | 10 |
| 1049225 | acetaminophen 325 MG / oxycodone hydrochloride 7.5 MG Oral Tablet | SCD | 42777191-0454-4ccb-8fc3-8b18b0ee43f7 | 10 |
| 1049214 | APAP 325 MG / oxycodone hydrochloride 10 MG Oral Tablet | SY | 42777191-0454-4ccb-8fc3-8b18b0ee43f7 | 10 |
| 1049635 | APAP 325 MG / Oxycodone Hydrochloride 2.5 MG Oral Tablet | SY | 42777191-0454-4ccb-8fc3-8b18b0ee43f7 | 10 |
| 1049221 | APAP 325 MG / oxycodone hydrochloride 5 MG Oral Tablet | SY | 42777191-0454-4ccb-8fc3-8b18b0ee43f7 | 10 |
| 1049225 | APAP 325 MG / oxycodone hydrochloride 7.5 MG Oral Tablet | SY | 42777191-0454-4ccb-8fc3-8b18b0ee43f7 | 10 |
| 1049214 | oxyCODONE 10 MG / acetaminophen 325 MG Oral Tablet | PSN | 71c7a627-6ed9-4f49-8cdc-b3228c021e64 | 1 |
| 1049221 | oxyCODONE 5 MG / acetaminophen 325 MG Oral Tablet | PSN | 71c7a627-6ed9-4f49-8cdc-b3228c021e64 | 1 |
| 1049225 | oxyCODONE 7.5 MG / acetaminophen 325 MG Oral Tablet | PSN | 71c7a627-6ed9-4f49-8cdc-b3228c021e64 | 1 |
| 1049635 | oxyCODONE HCl 2.5 MG / acetaminophen 325 MG Oral Tablet | PSN | 71c7a627-6ed9-4f49-8cdc-b3228c021e64 | 1 |
| 1049214 | acetaminophen 325 MG / oxycodone hydrochloride 10 MG Oral Tablet | SCD | 71c7a627-6ed9-4f49-8cdc-b3228c021e64 | 1 |
| 1049635 | acetaminophen 325 MG / oxycodone hydrochloride 2.5 MG Oral Tablet | SCD | 71c7a627-6ed9-4f49-8cdc-b3228c021e64 | 1 |
| 1049221 | acetaminophen 325 MG / oxycodone hydrochloride 5 MG Oral Tablet | SCD | 71c7a627-6ed9-4f49-8cdc-b3228c021e64 | 1 |
| 1049225 | acetaminophen 325 MG / oxycodone hydrochloride 7.5 MG Oral Tablet | SCD | 71c7a627-6ed9-4f49-8cdc-b3228c021e64 | 1 |
| 1049214 | APAP 325 MG / oxycodone hydrochloride 10 MG Oral Tablet | SY | 71c7a627-6ed9-4f49-8cdc-b3228c021e64 | 1 |
| 1049635 | APAP 325 MG / Oxycodone Hydrochloride 2.5 MG Oral Tablet | SY | 71c7a627-6ed9-4f49-8cdc-b3228c021e64 | 1 |
| 1049221 | APAP 325 MG / oxycodone hydrochloride 5 MG Oral Tablet | SY | 71c7a627-6ed9-4f49-8cdc-b3228c021e64 | 1 |
| 1049225 | APAP 325 MG / oxycodone hydrochloride 7.5 MG Oral Tablet | SY | 71c7a627-6ed9-4f49-8cdc-b3228c021e64 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 31722-948-01 | 31722094801 | 100 TABLET in 1 BOTTLE (31722-948-01) | 100 tablet | 2019-03-15 | 0000-00-00 | No | No | Current |
| 31722-948-05 | 31722094805 | 500 TABLET in 1 BOTTLE (31722-948-05) | 500 tablet | 2019-03-15 | 0000-00-00 | No | No | Current |