Oxycodone and Acetaminophen
- Product NDC
- 63187-984
- 11-digit product format
- 631870984
- Labeler code
- 63187
- Product ID
- 63187-984_09fe7043-1a50-4d4a-89ff-e0acc2850023
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Oxycodone and Acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA201972
- Marketing category
- ANDA
- Marketing start
- 2013-07-15
- 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 | 1049221 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63187-984-10 | Oxycodone and Acetaminophen | 10 in 1 BOTTLE | TABLET | 10 | | 3 |
| 63187-984-12 | Oxycodone and Acetaminophen | 12 in 1 BOTTLE | TABLET | 12 | | 3 |
| 63187-984-15 | Oxycodone and Acetaminophen | 15 in 1 BOTTLE | TABLET | 15 | | 3 |
| 63187-984-30 | Oxycodone and Acetaminophen | 30 in 1 BOTTLE | TABLET | 30 | | 3 |
| 63187-984-60 | Oxycodone and Acetaminophen | 60 in 1 BOTTLE | TABLET | 60 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63187-984 | OXYCODONE AND ACETAMINOPHEN TABLET [PROFICIENT RX LP] | 3 | Current NDC, Legacy NDC, 5 package rows | 20191105_dd4dbe5b-8d07-4a96-a78d-2f20da761dad.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 |
|---|
| 63187-984-10 | 63187098410 | 10 TABLET in 1 BOTTLE (63187-984-10) | 10 tablet | 2018-02-01 | 0000-00-00 | No | No | Current |
| 63187-984-12 | 63187098412 | 12 TABLET in 1 BOTTLE (63187-984-12) | 12 tablet | 2018-02-01 | 0000-00-00 | No | No | Current |
| 63187-984-15 | 63187098415 | 15 TABLET in 1 BOTTLE (63187-984-15) | 15 tablet | 2018-02-01 | 0000-00-00 | No | No | Current |
| 63187-984-30 | 63187098430 | 30 TABLET in 1 BOTTLE (63187-984-30) | 30 tablet | 2018-02-01 | 0000-00-00 | No | No | Current |
| 63187-984-60 | 63187098460 | 60 TABLET in 1 BOTTLE (63187-984-60) | 60 tablet | 2018-02-01 | 0000-00-00 | No | No | Current |