Oxycodone and Acetaminophen
- Product NDC
- 10702-186
- 11-digit product format
- 107020186
- Labeler code
- 10702
- Product ID
- 10702-186_5104be8c-6b64-f19a-e063-6294a90ac130
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Oxycodone and Acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- KVK-Tech, Inc.
- Application
- ANDA210644
- Marketing category
- ANDA
- Marketing start
- 2018-02-09
- Substance
- ACETAMINOPHEN; OXYCODONE
- 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 and Acetaminophen
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ACETAMINOPHEN | 325 mg/1 |
| OXYCODONE | 7.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 362O9ITL9D, CD35PMG570 |
| Rxcui | 1049214, 1049221, 1049225, 1049635 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 10702-186-01 | Oxycodone and Acetaminophen | 100 in 1 BOTTLE | TABLET | 100 | | 21 |
| 10702-186-10 | Oxycodone and Acetaminophen | 1000 in 1 BOTTLE | TABLET | 1000 | | 21 |
| 10702-186-50 | Oxycodone and Acetaminophen | 500 in 1 BOTTLE | TABLET | 500 | | 21 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 10702-186 | OXYCODONE AND ACETAMINOPHEN TABLET [KVK-TECH, INC.] | 19 | Current NDC, Legacy NDC, 3 package rows | 20240315_f9cf218c-af5e-4249-aa3b-a8555ed02278.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 |
|---|
| 10702-186-01 | 10702018601 | 100 TABLET in 1 BOTTLE (10702-186-01) | 100 tablet | 2018-02-09 | 0000-00-00 | No | No | Current |
| 10702-186-10 | 10702018610 | 1000 TABLET in 1 BOTTLE (10702-186-10) | 1000 tablet | 2018-02-09 | 0000-00-00 | No | No | Current |
| 10702-186-50 | 10702018650 | 500 TABLET in 1 BOTTLE (10702-186-50) | 500 tablet | 2018-02-09 | 0000-00-00 | No | No | Current |