Oxycodone and Acetaminophen
- Product NDC
- 70010-670
- 11-digit product format
- 700100670
- Labeler code
- 70010
- Product ID
- 70010-670_4221a53d-0185-7219-e063-6394a90a7ff7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Oxycodone and Acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Granules Pharmaceuticals Inc.
- Application
- ANDA211708
- Marketing category
- ANDA
- Marketing start
- 2022-01-01
- Substance
- ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
- Active strength
- 325; 10 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 | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 362O9ITL9D, C1ENJ2TE6C |
| Rxcui | 1049214, 1049221, 1049225, 1049635 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70010-670-01 | Oxycodone and Acetaminophen | 100 in 1 BOTTLE | TABLET | 100 | | 18 |
| 70010-670-05 | Oxycodone and Acetaminophen | 500 in 1 BOTTLE | TABLET | 500 | | 18 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70010-670 | OXYCODONE AND ACETAMINOPHEN TABLET [GRANULES PHARMACEUTICALS INC.] | 16 | Current NDC, Legacy NDC, 2 package rows | 20241107_cc966d57-7cdc-4de3-bbcf-718e2fce9cb7.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70010-670-01 | 70010067001 | 100 TABLET in 1 BOTTLE (70010-670-01) | 100 tablet | 2022-01-01 | No | No | Current |
| 70010-670-05 | 70010067005 | 500 TABLET in 1 BOTTLE (70010-670-05) | 500 tablet | 2022-01-01 | No | No | Current |