Oxycodone Hydrochloride
- Product NDC
- 76420-365
- 11-digit product format
- 764200365
- Labeler code
- 76420
- Product ID
- 76420-365_46f094b6-4d19-8b98-e063-6294a90a5aac
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Oxycodone Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Asclemed USA, Inc.
- Application
- ANDA077712
- Marketing category
- ANDA
- Marketing start
- 2024-09-10
- Substance
- OXYCODONE HYDROCHLORIDE
- Active strength
- 20 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 | 20 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | C1ENJ2TE6C |
| Rxcui | 1049611, 1049618, 1049621, 1049683, 1049686 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 76420-365-01 | Oxycodone Hydrochloride | 100 in 1 BOTTLE, PLASTIC | TABLET | 100 | | 2 |
| 76420-365-10 | Oxycodone Hydrochloride | 10 in 1 BOTTLE, PLASTIC | TABLET | 10 | | 2 |
| 76420-365-30 | Oxycodone Hydrochloride | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | | 2 |
| 76420-365-60 | Oxycodone Hydrochloride | 60 in 1 BOTTLE, PLASTIC | TABLET | 60 | | 2 |
| 76420-365-90 | Oxycodone Hydrochloride | 90 in 1 BOTTLE, PLASTIC | TABLET | 90 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 76420-365-01 | 76420036501 | 100 TABLET in 1 BOTTLE, PLASTIC (76420-365-01) | 100 tablet | 2025-05-27 | No | No | Historical |
| 76420-365-10 | 76420036510 | 10 TABLET in 1 BOTTLE, PLASTIC (76420-365-10) | 10 tablet | 2025-12-27 | No | No | Historical |
| 76420-365-30 | 76420036530 | 30 TABLET in 1 BOTTLE, PLASTIC (76420-365-30) | 30 tablet | 2025-05-27 | No | No | Historical |
| 76420-365-60 | 76420036560 | 60 TABLET in 1 BOTTLE, PLASTIC (76420-365-60) | 60 tablet | 2025-05-27 | No | No | Historical |
| 76420-365-90 | 76420036590 | 90 TABLET in 1 BOTTLE, PLASTIC (76420-365-90) | 90 tablet | 2025-05-27 | No | No | Historical |