Oxycodone Hydrochloride
- Product NDC
- 62559-151
- 11-digit product format
- 625590151
- Labeler code
- 62559
- Product ID
- 62559-151_2dd00699-5e0a-42cd-8b52-0d8025d37d39
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Oxycodone Hydrochloride
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- ANI Pharmaceuticals, Inc.
- Application
- ANDA204979
- Marketing category
- ANDA
- Marketing start
- 2015-10-13
- 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 |
|---|
| 62559-151-15 | Oxycodone Hydrochloride | 5 mL in 1 CUP, UNIT-DOSE | SOLUTION | 5 | | 12 |
| 62559-151-16 | Oxycodone Hydrochloride | 473 mL in 1 BOTTLE | SOLUTION | 473 | | 12 |
| 62559-151-16 | Oxycodone Hydrochloride | 1 in 1 CARTON | SOLUTION | 1 | | 12 |
| 62559-151-40 | Oxycodone Hydrochloride | 40 in 1 CASE | SOLUTION | 40 | | 12 |
| 62559-151-50 | Oxycodone Hydrochloride | 50 in 1 CASE | SOLUTION | 50 | | 12 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| OXYCODONE HYDROCHLORIDE | ACTIVE INGREDIENT | C1ENJ2TE6C | OXYCODONE HYDROCHLORIDE SOLUTION [ANI PHARMACEUTICALS, INC.] | 1 | |
| OXYCODONE | ACTIVE MOIETY | CD35PMG570 | OXYCODONE HYDROCHLORIDE SOLUTION [ANI PHARMACEUTICALS, INC.] | 1 | |
| ANHYDROUS CITRIC ACID | INACTIVE INGREDIENT | XF417D3PSL | OXYCODONE HYDROCHLORIDE SOLUTION [ANI PHARMACEUTICALS, INC.] | 1 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | OXYCODONE HYDROCHLORIDE SOLUTION [ANI PHARMACEUTICALS, INC.] | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | OXYCODONE HYDROCHLORIDE SOLUTION [ANI PHARMACEUTICALS, INC.] | 1 | |
| POLOXAMER 188 | INACTIVE INGREDIENT | LQA7B6G8JG | OXYCODONE HYDROCHLORIDE SOLUTION [ANI PHARMACEUTICALS, INC.] | 1 | |
| SODIUM BENZOATE | INACTIVE INGREDIENT | OJ245FE5EU | OXYCODONE HYDROCHLORIDE SOLUTION [ANI PHARMACEUTICALS, INC.] | 1 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | OXYCODONE HYDROCHLORIDE SOLUTION [ANI PHARMACEUTICALS, INC.] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | OXYCODONE HYDROCHLORIDE SOLUTION [ANI PHARMACEUTICALS, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62559-151 | OXYCODONE HYDROCHLORIDE SOLUTION [ANI PHARMACEUTICALS, INC.] | 10 | Current NDC, Legacy NDC, 5 package rows | 20240502_819ed9fc-0a21-4ed0-9080-91912c5f8ce2.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 |
|---|
| 62559-151-15 | 62559015115 | 5 mL in 1 CUP, UNIT-DOSE | 5 ml | | | | | Historical |
| 62559-151-16 | 62559015116 | 1 BOTTLE in 1 CARTON (62559-151-16) / 473 mL in 1 BOTTLE | 1 bottle | 2015-10-13 | 0000-00-00 | No | No | Current |
| 62559-151-40 | 62559015140 | 40 in 1 CASE | | | | | | Historical |
| 62559-151-50 | 62559015150 | 50 in 1 CASE | | | | | | Historical |