Oxycodone Hydrochloride
- Product NDC
- 0904-6828
- 11-digit product format
- 009046828
- Labeler code
- 0904
- Product ID
- 0904-6828_f661966e-fbda-4dbb-85de-b31056fc7032
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Oxycodone Hydrochloride
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- MAJOR PHARMACEUTICALS
- Application
- ANDA207511
- Marketing category
- ANDA
- Marketing start
- 2016-11-23
- Substance
- OXYCODONE HYDROCHLORIDE
- Active strength
- 5 mg/5mL
- 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 | 5 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | C1ENJ2TE6C |
| Rxcui | 1049604 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0904-6828-05 | Oxycodone Hydrochloride | 5 mL in 1 CUP, UNIT-DOSE | SOLUTION | 5 | | 8 |
| 0904-6828-92 | Oxycodone Hydrochloride | 10 in 1 TRAY | SOLUTION | 10 | | 8 |
| 0904-6828-92 | Oxycodone Hydrochloride | 5 in 1 CARTON | SOLUTION | 5 | | 8 |
| 0904-6828-94 | Oxycodone Hydrochloride | 10 in 1 TRAY | SOLUTION | 10 | | 8 |
| 0904-6828-94 | Oxycodone Hydrochloride | 4 in 1 CARTON | SOLUTION | 4 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0904-6828 | OXYCODONE HYDROCHLORIDE SOLUTION [MAJOR PHARMACEUTICALS] | 7 | Current NDC, Legacy NDC, 5 package rows | 20250516_6d249bc5-79c4-4c42-a71b-d667c75163db.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 |
|---|
| 0904-6828-05 | 00904682805 | 5 mL in 1 CUP, UNIT-DOSE | 5 ml | | | | | Historical |
| 0904-6828-92 | 00904682892 | 5 TRAY in 1 CARTON (0904-6828-92) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0904-6828-05) | 5 tray | 2016-11-23 | 0000-00-00 | No | No | Current |
| 0904-6828-94 | 00904682894 | 4 TRAY in 1 CARTON (0904-6828-94) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0904-6828-05) | 4 tray | 2016-11-23 | 0000-00-00 | No | No | Current |