Oxycodone hydrochloride
- Product NDC
- 47781-265
- 11-digit product format
- 477810265
- Labeler code
- 47781
- Product ID
- 47781-265_aa023689-6275-e0a0-ab08-d45edc45ec40
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Oxycodone hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Alvogen, Inc.
- Application
- ANDA202116
- Marketing category
- ANDA
- Marketing start
- 2011-12-30
- Substance
- OXYCODONE HYDROCHLORIDE
- Active strength
- 30 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 hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| OXYCODONE HYDROCHLORIDE | 30 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | C1ENJ2TE6C |
| Rxcui | 1049611, 1049618, 1049621 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 47781-265-01 | Oxycodone hydrochloride | 100 in 1 BOTTLE | TABLET | 100 | | 18 |
| 47781-265-05 | Oxycodone hydrochloride | 500 in 1 BOTTLE | TABLET | 500 | | 18 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| OXYCODONE HYDROCHLORIDE | ACTIVE INGREDIENT | C1ENJ2TE6C | OXYCODONE HYDROCHLORIDE TABLET [ALVOGEN, INC.] | 6 | |
| OXYCODONE | ACTIVE MOIETY | CD35PMG570 | OXYCODONE HYDROCHLORIDE TABLET [ALVOGEN, INC.] | 6 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | OXYCODONE HYDROCHLORIDE TABLET [ALVOGEN, INC.] | 6 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | OXYCODONE HYDROCHLORIDE TABLET [ALVOGEN, INC.] | 6 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | OXYCODONE HYDROCHLORIDE TABLET [ALVOGEN, INC.] | 6 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | OXYCODONE HYDROCHLORIDE TABLET [ALVOGEN, INC.] | 6 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | OXYCODONE HYDROCHLORIDE TABLET [ALVOGEN, INC.] | 6 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | OXYCODONE HYDROCHLORIDE TABLET [ALVOGEN, INC.] | 6 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 47781-265 | OXYCODONE HYDROCHLORIDE TABLET [ALVOGEN, INC.] | 17 | Current NDC, Legacy NDC, 2 package rows | 20250427_20bb6bb4-230a-c9c2-01d8-a6e9341e96ba.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 |
|---|
| 47781-265-01 | 47781026501 | 100 TABLET in 1 BOTTLE (47781-265-01) | 100 tablet | 2011-12-30 | 0000-00-00 | No | No | Current |
| 47781-265-05 | 47781026505 | 500 TABLET in 1 BOTTLE (47781-265-05) | 500 tablet | 2011-12-30 | 0000-00-00 | No | No | Current |