Oxycodone and Acetaminophen
- Product NDC
- 65162-207
- 11-digit product format
- 651620207
- Labeler code
- 65162
- Product ID
- 65162-207_34daf86b-3616-4e9e-a43e-56666cf95fa4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Oxycodone and Acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals LLC
- Application
- ANDA040778
- Marketing category
- ANDA
- Marketing start
- 2013-11-01
- Substance
- ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
- Active strength
- 325; 7.5 mg/1; 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Oxycodone and Acetaminophen
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 325 mg/1 |
| OXYCODONE HYDROCHLORIDE | 7.5 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 362O9ITL9D, C1ENJ2TE6C |
| Rxcui | 1049225 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 65162-207-03 | 2024-02-09 | C162847 | 48780-1 | 1030e365-41f8-111a-e063-dadaa90a10e2 | Oxycodone and Acetaminophen Tablets, USP CII (7.5 mg / 325 mg) |
| 65162-207-10 | 2024-02-09 | C162847 | 48780-1 | 1030e365-41f8-111a-e063-dadaa90a10e2 | Oxycodone and Acetaminophen Tablets, USP CII (7.5 mg / 325 mg) |
| 65162-207-50 | 2024-02-09 | C162847 | 48780-1 | 1030e365-41f8-111a-e063-dadaa90a10e2 | Oxycodone and Acetaminophen Tablets, USP CII (7.5 mg / 325 mg) |
| 65162-207-03 | 2024-01-30 | C162847 | 48780-1 | 1030e365-41f8-111a-e063-dadaa90a10e2 | Oxycodone and Acetaminophen Tablets, USP CII (7.5 mg / 325 mg) |
| 65162-207-10 | 2024-01-30 | C162847 | 48780-1 | 1030e365-41f8-111a-e063-dadaa90a10e2 | Oxycodone and Acetaminophen Tablets, USP CII (7.5 mg / 325 mg) |
| 65162-207-50 | 2024-01-30 | C162847 | 48780-1 | 1030e365-41f8-111a-e063-dadaa90a10e2 | Oxycodone and Acetaminophen Tablets, USP CII (7.5 mg / 325 mg) |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 65162-207-03 | Oxycodone and Acetaminophen | 30 in 1 BOTTLE | TABLET | 30 | 35 | |
| 65162-207-10 | Oxycodone and Acetaminophen | 100 in 1 BOTTLE | TABLET | 100 | 35 | |
| 65162-207-50 | Oxycodone and Acetaminophen | 500 in 1 BOTTLE | TABLET | 500 | 35 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1049225 | oxyCODONE 7.5 MG / acetaminophen 325 MG Oral Tablet | PSN | c5cc2e88-aa00-46bd-91dc-901c3a7c899c | 35 |
| 1049225 | acetaminophen 325 MG / oxycodone hydrochloride 7.5 MG Oral Tablet | SCD | c5cc2e88-aa00-46bd-91dc-901c3a7c899c | 35 |
| 1049225 | APAP 325 MG / oxycodone hydrochloride 7.5 MG Oral Tablet | SY | c5cc2e88-aa00-46bd-91dc-901c3a7c899c | 35 |
| 1049214 | oxyCODONE 10 MG / acetaminophen 325 MG Oral Tablet | PSN | 7055acd5-1cbb-397e-e053-2a91aa0a3852 | 9 |
| 1049221 | oxyCODONE 5 MG / acetaminophen 325 MG Oral Tablet | PSN | 7055acd5-1cbb-397e-e053-2a91aa0a3852 | 9 |
| 1049225 | oxyCODONE 7.5 MG / acetaminophen 325 MG Oral Tablet | PSN | 7055acd5-1cbb-397e-e053-2a91aa0a3852 | 9 |
| 1049214 | acetaminophen 325 MG / oxycodone hydrochloride 10 MG Oral Tablet | SCD | 7055acd5-1cbb-397e-e053-2a91aa0a3852 | 9 |
| 1049221 | acetaminophen 325 MG / oxycodone hydrochloride 5 MG Oral Tablet | SCD | 7055acd5-1cbb-397e-e053-2a91aa0a3852 | 9 |
| 1049225 | acetaminophen 325 MG / oxycodone hydrochloride 7.5 MG Oral Tablet | SCD | 7055acd5-1cbb-397e-e053-2a91aa0a3852 | 9 |
| 1049214 | APAP 325 MG / oxycodone hydrochloride 10 MG Oral Tablet | SY | 7055acd5-1cbb-397e-e053-2a91aa0a3852 | 9 |
| 1049221 | APAP 325 MG / oxycodone hydrochloride 5 MG Oral Tablet | SY | 7055acd5-1cbb-397e-e053-2a91aa0a3852 | 9 |
| 1049225 | APAP 325 MG / oxycodone hydrochloride 7.5 MG Oral Tablet | SY | 7055acd5-1cbb-397e-e053-2a91aa0a3852 | 9 |
| 1049225 | oxyCODONE 7.5 MG / acetaminophen 325 MG Oral Tablet | PSN | 2a67aa02-3ef3-0ef8-e054-00144ff88e88 | 1 |
| 1049225 | acetaminophen 325 MG / oxycodone hydrochloride 7.5 MG Oral Tablet | SCD | 2a67aa02-3ef3-0ef8-e054-00144ff88e88 | 1 |
| 1049225 | APAP 325 MG / oxycodone hydrochloride 7.5 MG Oral Tablet | SY | 2a67aa02-3ef3-0ef8-e054-00144ff88e88 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 65162-207-03 | 65162020703 | 30 TABLET in 1 BOTTLE (65162-207-03) | 30 tablet | 2013-11-01 | 0000-00-00 | No | No | Current |
| 65162-207-10 | 65162020710 | 100 TABLET in 1 BOTTLE (65162-207-10) | 100 tablet | 2013-11-01 | 0000-00-00 | No | No | Current |
| 65162-207-50 | 65162020750 | 500 TABLET in 1 BOTTLE (65162-207-50) | 500 tablet | 2013-11-01 | 0000-00-00 | No | No | Current |