Oxycodone and Acetaminophen
- Product NDC
- 76420-209
- 11-digit product format
- 764200209
- Labeler code
- 76420
- Product ID
- 76420-209_de3d43dc-ba4c-e233-e053-2995a90ac632
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Oxycodone and Acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Asclemed USA, Inc.
- Application
- ANDA201278
- Marketing category
- ANDA
- Marketing start
- 2014-08-28
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 76420-209-01 | Oxycodone and Acetaminophen | 100 in 1 BOTTLE, PLASTIC | TABLET | 100 | | 1 |
| 76420-209-30 | Oxycodone and Acetaminophen | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | | 1 |
| 76420-209-60 | Oxycodone and Acetaminophen | 60 in 1 BOTTLE, PLASTIC | TABLET | 60 | | 1 |
| 76420-209-90 | Oxycodone and Acetaminophen | 90 in 1 BOTTLE, PLASTIC | TABLET | 90 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76420-209 | OXYCODONE AND ACETAMINOPHEN TABLET [ASCLEMED USA, INC.] | 1 | Current NDC, Legacy NDC, 4 package rows | 20220511_3e89f02d-b6e7-4641-82d4-f756518a8914.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 |
|---|
| 76420-209-01 | 76420020901 | 100 TABLET in 1 BOTTLE, PLASTIC (76420-209-01) | 100 tablet | 2022-05-05 | 0000-00-00 | No | No | Current |
| 76420-209-30 | 76420020930 | 30 TABLET in 1 BOTTLE, PLASTIC (76420-209-30) | 30 tablet | 2022-05-05 | 0000-00-00 | No | No | Current |
| 76420-209-60 | 76420020960 | 60 TABLET in 1 BOTTLE, PLASTIC (76420-209-60) | 60 tablet | 2022-05-05 | 0000-00-00 | No | No | Current |
| 76420-209-90 | 76420020990 | 90 TABLET in 1 BOTTLE, PLASTIC (76420-209-90) | 90 tablet | 2022-05-05 | 0000-00-00 | No | No | Current |