Oxycodone and Acetaminophen
- Product NDC
- 68084-710
- 11-digit product format
- 680840710
- Labeler code
- 68084
- Product ID
- 68084-710_1cfe716a-f97c-7f6f-e063-6394a90ad63c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Oxycodone and Acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- American Health Packaging
- Application
- ANDA202677
- Marketing category
- ANDA
- Marketing start
- 2014-06-04
- 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, 1049225 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68084-710-01 | Oxycodone and Acetaminophen | 100 in 1 BOX, UNIT-DOSE | TABLET | 100 | | 8 |
| 68084-710-11 | Oxycodone and Acetaminophen | 1 in 1 BLISTER PACK | TABLET | 1 | | 8 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68084-710 | OXYCODONE AND ACETAMINOPHEN TABLET [AMERICAN HEALTH PACKAGING] | 8 | Current NDC, Legacy NDC, 2 package rows | 20240713_03c9ff0d-46e8-448c-944a-7ad59d1afd6d.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 |
|---|
| 68084-710-01 | 68084071001 | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-710-01) / 1 TABLET in 1 BLISTER PACK (68084-710-11) | 100 blister pack | 2014-06-04 | 0000-00-00 | No | No | Current |
| 68084-710-11 | 68084071011 | 1 in 1 BLISTER PACK | | | | | | Historical |