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 table| Ingredient | Strength |
|---|
| ACETAMINOPHEN | 325 mg/1 |
| OXYCODONE HYDROCHLORIDE | 7.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 362O9ITL9D, C1ENJ2TE6C |
| Rxcui | 1049225 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| 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 Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ACETAMINOPHEN | ACTIVE INGREDIENT | 362O9ITL9D | OXYCODONE AND ACETAMINOPHEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 6 | |
| OXYCODONE HYDROCHLORIDE | ACTIVE INGREDIENT | C1ENJ2TE6C | OXYCODONE AND ACETAMINOPHEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 6 | |
| ACETAMINOPHEN | ACTIVE MOIETY | 362O9ITL9D | OXYCODONE AND ACETAMINOPHEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 6 | |
| OXYCODONE | ACTIVE MOIETY | CD35PMG570 | OXYCODONE AND ACETAMINOPHEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 6 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | OXYCODONE AND ACETAMINOPHEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 6 | |
| CROSPOVIDONE (15 MPA.S AT 5%) | INACTIVE INGREDIENT | 68401960MK | OXYCODONE AND ACETAMINOPHEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 6 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | OXYCODONE AND ACETAMINOPHEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 6 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | OXYCODONE AND ACETAMINOPHEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 6 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | OXYCODONE AND ACETAMINOPHEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 6 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | OXYCODONE AND ACETAMINOPHEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 6 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | OXYCODONE AND ACETAMINOPHEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 6 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65162-207 | OXYCODONE AND ACETAMINOPHEN TABLET [AMNEAL PHARMACEUTICALS LLC] | 32 | Current NDC, Legacy NDC, 3 package rows | 20240316_c5cc2e88-aa00-46bd-91dc-901c3a7c899c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| 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 |