OXYCODONE HYDROCHLORIDE
- Product NDC
- 68071-3600
- 11-digit product format
- 680713600
- Labeler code
- 68071
- Product ID
- 68071-3600_17f796b6-3f89-c988-e063-6394a90a7cb8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- OXYCODONE HYDROCHLORIDE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA091393
- Marketing category
- ANDA
- Marketing start
- 2013-10-18
- Substance
- OXYCODONE HYDROCHLORIDE
- Active strength
- 5 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 HYDROCHLORIDE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| OXYCODONE HYDROCHLORIDE | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | C1ENJ2TE6C |
| Rxcui | 1049621 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68071-3600-4 | OXYCODONE HYDROCHLORIDE | 4 in 1 BOTTLE | TABLET | 4 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-3600 | OXYCODONE HYDROCHLORIDE TABLET [NUCARE PHARMACEUTICALS,INC.] | 1 | Current NDC, 1 package rows | 20240509_17f7946d-e889-b736-e063-6394a90a42e0.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68071-3600-4 | 68071360004 | 4 TABLET in 1 BOTTLE (68071-3600-4) | 4 tablet | 2024-05-08 | No | No | Current |