Oxycodone and Acetaminophen
- Product NDC
- 63187-363
- 11-digit product format
- 631870363
- Labeler code
- 63187
- Product ID
- 63187-363_b9d14bcb-219d-406c-85c5-405c9e8b8508
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Oxycodone and Acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA202677
- Marketing category
- ANDA
- Marketing start
- 2012-01-17
- 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 | C1ENJ2TE6C, 362O9ITL9D |
| Rxcui | 1049214, 1049221 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63187-363-12 | Oxycodone and Acetaminophen | 12 in 1 BOTTLE | TABLET | 12 | | 5 |
| 63187-363-15 | Oxycodone and Acetaminophen | 15 in 1 BOTTLE | TABLET | 15 | | 5 |
| 63187-363-20 | Oxycodone and Acetaminophen | 20 in 1 BOTTLE | TABLET | 20 | | 5 |
| 63187-363-30 | Oxycodone and Acetaminophen | 30 in 1 BOTTLE | TABLET | 30 | | 5 |
| 63187-363-60 | Oxycodone and Acetaminophen | 60 in 1 BOTTLE | TABLET | 60 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63187-363 | OXYCODONE AND ACETAMINOPHEN TABLET [PROFICIENT RX LP] | 5 | Current NDC, Legacy NDC, 5 package rows | 20191121_0233de1c-466b-4842-8604-6d879aa36a4b.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 |
|---|
| 63187-363-12 | 63187036312 | 12 TABLET in 1 BOTTLE (63187-363-12) | 12 tablet | 2016-11-01 | 0000-00-00 | No | No | Current |
| 63187-363-15 | 63187036315 | 15 TABLET in 1 BOTTLE (63187-363-15) | 15 tablet | 2016-08-01 | 0000-00-00 | No | No | Current |
| 63187-363-20 | 63187036320 | 20 TABLET in 1 BOTTLE (63187-363-20) | 20 tablet | 2016-08-01 | 0000-00-00 | No | No | Current |
| 63187-363-30 | 63187036330 | 30 TABLET in 1 BOTTLE (63187-363-30) | 30 tablet | 2016-08-01 | 0000-00-00 | No | No | Current |
| 63187-363-60 | 63187036360 | 60 TABLET in 1 BOTTLE (63187-363-60) | 60 tablet | 2016-08-01 | 0000-00-00 | No | No | Current |