OXYCODONE AND ACETAMINOPHEN
- Product NDC
- 10702-238
- 11-digit product format
- 107020238
- Labeler code
- 10702
- Product ID
- 10702-238_483734fe-f7da-e43c-e063-6294a90a8191
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- oxycodone and acetaminophen
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- KVK-Tech, Inc.
- Application
- ANDA211499
- Marketing category
- ANDA
- Marketing start
- 2019-12-05
- Substance
- ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
- Active strength
- 325; 5 mg/5mL; mg/5mL
- 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 AND ACETAMINOPHEN
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ACETAMINOPHEN | 325 mg/5mL |
| OXYCODONE HYDROCHLORIDE | 5 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 362O9ITL9D, C1ENJ2TE6C |
| Rxcui | 1049580 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 10702-238-50 | OXYCODONE AND ACETAMINOPHEN | 500 mL in 1 BOTTLE | SOLUTION | 500 | | 15 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 10702-238 | OXYCODONE AND ACETAMINOPHEN SOLUTION [KVK-TECH, INC.] | 14 | Current NDC, Legacy NDC, 1 package rows | 20240314_9986aa04-c976-4654-8ad7-b97d2eecea93.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 |
|---|
| 10702-238-50 | 10702023850 | 500 mL in 1 BOTTLE (10702-238-50) | 500 ml | 2019-12-05 | 0000-00-00 | No | No | Current |