oxycodone and acetaminophen
- Product NDC
- 43598-546
- 11-digit product format
- 435980546
- Labeler code
- 43598
- Product ID
- 43598-546_f430020f-5a30-63e3-c72c-ce1736aa8061
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- oxycodone and acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Dr. Reddy
- Application
- ANDA207510
- Marketing category
- ANDA
- Marketing start
- 2018-07-09
- Marketing end
- 0000-00-00
- Substance
- ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
- Active strength
- 325 mg/1; mg/1
- Pharmacologic classes
- Full Opioid Agonists [MoA], Opioid Agonist [EPC]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
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 |
|---|
| 43598-546-01 | oxycodone and acetaminophen | 100 in 1 BOTTLE | TABLET | 100 | | 3 |
| 43598-546-05 | oxycodone and acetaminophen | 500 in 1 BOTTLE | TABLET | 500 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43598-546 | OXYCODONE AND ACETAMINOPHEN TABLET [DR. REDDY’S LABORATORIES INC.] | 3 | Legacy NDC, 2 package rows | 20221224_1fc33ab3-9357-53f2-508a-ec0695eef110.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 |
|---|
| 43598-546-01 | 43598054601 | 100 TABLET in 1 BOTTLE (43598-546-01) | 100 tablet | 2018-07-09 | 0000-00-00 | No | No | Current |
| 43598-546-05 | 43598054605 | 500 TABLET in 1 BOTTLE (43598-546-05) | 500 tablet | 2018-07-09 | 0000-00-00 | No | No | Current |