oxycodone hydrochloride
- Product NDC
- 0054-0390
- 11-digit product format
- 000540390
- Labeler code
- 0054
- Product ID
- 0054-0390_47e856d4-de7d-49aa-8671-d1b4a35bad4d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- oxycodone hydrochloride
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Hikma Pharmceuticals USA Inc.
- Application
- ANDA204037
- Marketing category
- ANDA
- Marketing start
- 2014-09-04
- 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 |
|---|
| 0054-0390-41 | oxycodone hydrochloride | 15 mL in 1 BOTTLE | SOLUTION | 15 | | 18 |
| 0054-0390-63 | oxycodone hydrochloride | 500 mL in 1 BOTTLE | SOLUTION | 500 | | 18 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| OXYCODONE HYDROCHLORIDE | ACTIVE INGREDIENT | C1ENJ2TE6C | OXYCODONE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC.] | 1 | |
| OXYCODONE | ACTIVE MOIETY | CD35PMG570 | OXYCODONE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC.] | 1 | |
| ANHYDROUS CITRIC ACID | INACTIVE INGREDIENT | XF417D3PSL | OXYCODONE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC.] | 1 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | OXYCODONE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC.] | 1 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | OXYCODONE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC.] | 1 | |
| SODIUM BENZOATE | INACTIVE INGREDIENT | OJ245FE5EU | OXYCODONE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC.] | 1 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | OXYCODONE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC.] | 1 | |
| SUCRALOSE | INACTIVE INGREDIENT | 96K6UQ3ZD4 | OXYCODONE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC.] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | OXYCODONE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0054-0390 | OXYCODONE HYDROCHLORIDE SOLUTION [HIKMA PHARMCEUTICALS USA INC.] | 12 | Current NDC, Legacy NDC, 2 package rows | 20240509_d8e87c66-f872-4e1d-9ade-ef11490af63b.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 |
|---|
| 0054-0390-41 | 00054039041 | 15 mL in 1 BOTTLE (0054-0390-41) | 15 ml | 2014-09-04 | 2026-08-31 | No | No | Current |
| 0054-0390-63 | 00054039063 | 500 mL in 1 BOTTLE (0054-0390-63) | 500 ml | 2014-09-04 | 0000-00-00 | No | No | Current |