Oxycodone Hydrochloride
- Product NDC
- 64950-354
- 11-digit product format
- 649500354
- Labeler code
- 64950
- Product ID
- 64950-354_75ee6920-096a-4dd9-ae98-6991ab84daff
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Oxycodone Hydrochloride
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Genus Lifesciences Inc.
- Application
- NDA200535
- Marketing category
- NDA
- Marketing start
- 2013-09-09
- 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, 1049615 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 64950-354-05 | Oxycodone Hydrochloride | 5 mL in 1 CUP, UNIT-DOSE | SOLUTION | 5 | | 25 |
| 64950-354-10 | Oxycodone Hydrochloride | 1 in 1 CARTON | SOLUTION | 1 | | 25 |
| 64950-354-10 | Oxycodone Hydrochloride | 100 mL in 1 BOTTLE, PLASTIC | SOLUTION | 100 | | 25 |
| 64950-354-45 | Oxycodone Hydrochloride | 40 in 1 CASE | SOLUTION | 40 | | 25 |
| 64950-354-50 | Oxycodone Hydrochloride | 500 mL in 1 BOTTLE, PLASTIC | SOLUTION | 500 | | 25 |
| 64950-354-50 | Oxycodone Hydrochloride | 1 in 1 CARTON | SOLUTION | 1 | | 25 |
| 64950-354-55 | Oxycodone Hydrochloride | 50 in 1 CASE | SOLUTION | 50 | | 25 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Oxycodone Hydrochloride | ACTIVE INGREDIENT | C1ENJ2TE6C | OXYCODONE HYDROCHLORIDE SOLUTION [LEHIGH VALLEY TECHNOLOGIES, INC.] | 11 | |
| Oxycodone | ACTIVE MOIETY | CD35PMG570 | OXYCODONE HYDROCHLORIDE SOLUTION [LEHIGH VALLEY TECHNOLOGIES, INC.] | 11 | |
| ANHYDROUS CITRIC ACID | INACTIVE INGREDIENT | XF417D3PSL | OXYCODONE HYDROCHLORIDE SOLUTION [LEHIGH VALLEY TECHNOLOGIES, INC.] | 11 | |
| D&C Yellow no. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | OXYCODONE HYDROCHLORIDE SOLUTION [LEHIGH VALLEY TECHNOLOGIES, INC.] | 11 | |
| FD&C Red no. 40 | INACTIVE INGREDIENT | WZB9127XOA | OXYCODONE HYDROCHLORIDE SOLUTION [LEHIGH VALLEY TECHNOLOGIES, INC.] | 11 | |
| saccharin sodium | INACTIVE INGREDIENT | SB8ZUX40TY | OXYCODONE HYDROCHLORIDE SOLUTION [LEHIGH VALLEY TECHNOLOGIES, INC.] | 11 | |
| sodium benzoate | INACTIVE INGREDIENT | OJ245FE5EU | OXYCODONE HYDROCHLORIDE SOLUTION [LEHIGH VALLEY TECHNOLOGIES, INC.] | 11 | |
| sorbitol | INACTIVE INGREDIENT | 506T60A25R | OXYCODONE HYDROCHLORIDE SOLUTION [LEHIGH VALLEY TECHNOLOGIES, INC.] | 11 | |
| TRISODIUM CITRATE DIHYDRATE | INACTIVE INGREDIENT | B22547B95K | OXYCODONE HYDROCHLORIDE SOLUTION [LEHIGH VALLEY TECHNOLOGIES, INC.] | 11 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | OXYCODONE HYDROCHLORIDE SOLUTION [LEHIGH VALLEY TECHNOLOGIES, INC.] | 11 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 64950-354 | OXYCODONE HYDROCHLORIDE SOLUTION [GENUS LIFESCIENCES INC.] | 23 | Current NDC, Legacy NDC, 7 package rows | 20240927_6869fec9-1837-4221-afd8-5cc6fadd025d.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 |
|---|
| 64950-354-05 | 64950035405 | 5 mL in 1 CUP, UNIT-DOSE | 5 ml | | | | | Historical |
| 64950-354-10 | 64950035410 | 1 BOTTLE, PLASTIC in 1 CARTON (64950-354-10) / 100 mL in 1 BOTTLE, PLASTIC | | 2013-09-09 | 0000-00-00 | No | No | Current |
| 64950-354-45 | 64950035445 | 40 CUP, UNIT-DOSE in 1 CASE (64950-354-45) / 5 mL in 1 CUP, UNIT-DOSE (64950-354-05) | | 2013-09-09 | 0000-00-00 | No | No | Current |
| 64950-354-50 | 64950035450 | 1 BOTTLE, PLASTIC in 1 CARTON (64950-354-50) / 500 mL in 1 BOTTLE, PLASTIC | | 2013-09-09 | 0000-00-00 | No | No | Current |
| 64950-354-55 | 64950035455 | 50 CUP, UNIT-DOSE in 1 CASE (64950-354-55) / 5 mL in 1 CUP, UNIT-DOSE (64950-354-05) | | 2013-09-09 | 0000-00-00 | No | No | Current |