OXYCODONE AND ACETAMINOPHEN
- Product NDC
- 0904-7093
- 11-digit product format
- 009047093
- Labeler code
- 0904
- Product ID
- 0904-7093_92f33065-bd48-442a-942c-088d790b955d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- oxycodone and acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA207510
- Marketing category
- ANDA
- Marketing start
- 2019-06-01
- Substance
- ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
- Active strength
- 325; 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 table| Ingredient | Strength |
|---|
| ACETAMINOPHEN | 325 mg/1 |
| OXYCODONE HYDROCHLORIDE | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 362O9ITL9D, C1ENJ2TE6C |
| Rxcui | 1049214, 1049221, 1049225 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0904-7093-61 | OXYCODONE AND ACETAMINOPHEN | 100 in 1 CARTON | TABLET | 100 | | 4 |
| 0904-7093-61 | OXYCODONE AND ACETAMINOPHEN | 1 in 1 BLISTER PACK | TABLET | 1 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0904-7093 | OXYCODONE AND ACETAMINOPHEN TABLET [MAJOR PHARMACEUTICALS] | 3 | Current NDC, Legacy NDC, 2 package rows | 20240920_1d52272f-a607-4002-a61c-341964522b82.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 |
|---|
| 0904-7093-61 | 00904709361 | 100 BLISTER PACK in 1 CARTON (0904-7093-61) / 1 TABLET in 1 BLISTER PACK | 100 blister pack | 2019-06-01 | 0000-00-00 | No | No | Current |