Oxycodone/APAP
- Product NDC
- 72189-375
- 11-digit product format
- 721890375
- Labeler code
- 72189
- Product ID
- 72189-375_4c4c55ca-eef7-8b39-e063-6294a90adf3f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Oxycodone/APAP
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Direct_Rx
- Application
- ANDA201278
- Marketing category
- ANDA
- Marketing start
- 2022-09-09
- 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/APAP
- 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 |
|---|
| 72189-375-30 | Oxycodone/APAP | 30 in 1 BOTTLE | TABLET | 30 | | 6 |
| 72189-375-60 | Oxycodone/APAP | 60 in 1 BOTTLE | TABLET | 60 | | 6 |
| 72189-375-72 | Oxycodone/APAP | 120 in 1 BOTTLE | TABLET | 120 | | 6 |
| 72189-375-90 | Oxycodone/APAP | 90 in 1 BOTTLE | TABLET | 90 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72189-375 | OXYCODONE/APAP TABLET [DIRECT_RX] | 5 | Current NDC, Legacy NDC, 4 package rows | 20250409_e84245ca-957f-e85b-e053-2a95a90a836b.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 |
|---|
| 72189-375-30 | 72189037530 | 30 TABLET in 1 BOTTLE (72189-375-30) | 30 tablet | 2022-09-09 | 0000-00-00 | No | No | Current |
| 72189-375-60 | 72189037560 | 60 TABLET in 1 BOTTLE (72189-375-60) | 60 tablet | 2022-09-09 | 0000-00-00 | No | No | Current |
| 72189-375-72 | 72189037572 | 120 TABLET in 1 BOTTLE (72189-375-72) | 120 tablet | 2022-09-09 | | No | No | Current |
| 72189-375-90 | 72189037590 | 90 TABLET in 1 BOTTLE (72189-375-90) | 90 tablet | 2022-09-09 | | No | No | Current |