Oxycodone Hydrochloride
- Product NDC
- 64950-353
- 11-digit product format
- 649500353
- Labeler code
- 64950
- Product ID
- 64950-353_dbbd3b81-5236-48da-901c-40bcdcddbf57
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Oxycodone Hydrochloride
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Genus Lifesciences Inc.
- Application
- NDA200535
- Marketing category
- NDA
- Marketing start
- 2010-10-20
- Marketing end
- 0000-00-00
- Substance
- OXYCODONE HYDROCHLORIDE
- Active strength
- 100 mg/5mL
- Pharmacologic classes
- Full Opioid Agonists [MoA], Opioid Agonist [EPC]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 64950-353-01 | Oxycodone Hydrochloride | 0.5 mL in 1 SYRINGE, PLASTIC | SOLUTION | 0.5 | | 25 |
| 64950-353-02 | Oxycodone Hydrochloride | 1 mL in 1 SYRINGE, PLASTIC | SOLUTION | 1 | | 25 |
| 64950-353-03 | Oxycodone Hydrochloride | 1 in 1 CARTON | SOLUTION | 1 | | 25 |
| 64950-353-03 | Oxycodone Hydrochloride | 30 mL in 1 BOTTLE, PLASTIC | SOLUTION | 30 | | 25 |
| 64950-353-51 | Oxycodone Hydrochloride | 50 in 1 CASE | SOLUTION | 50 | | 25 |
| 64950-353-52 | Oxycodone Hydrochloride | 50 in 1 CASE | SOLUTION | 50 | | 25 |
| 64950-353-91 | Oxycodone Hydrochloride | 5 in 1 POUCH | SOLUTION | 5 | | 25 |
| 64950-353-92 | Oxycodone Hydrochloride | 5 in 1 POUCH | SOLUTION | 5 | | 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 |
|---|
| 64950-353 | OXYCODONE HYDROCHLORIDE SOLUTION [GENUS LIFESCIENCES INC.] | 23 | Legacy NDC, 8 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 |
|---|
| 64950-353-01 | 64950035301 | 0.5 mL in 1 SYRINGE, PLASTIC | 0.5 ml | | | | | Historical |
| 64950-353-02 | 64950035302 | 1 mL in 1 SYRINGE, PLASTIC | 1 ml | | | | | Historical |
| 64950-353-03 | 64950035303 | 1 BOTTLE, PLASTIC in 1 CARTON (64950-353-03) > 30 mL in 1 BOTTLE, PLASTIC | | 2010-10-20 | 0000-00-00 | No | No | Current |
| 64950-353-51 | 64950035351 | 50 POUCH in 1 CASE (64950-353-51) > 5 SYRINGE, PLASTIC in 1 POUCH (64950-353-91) > .5 mL in 1 SYRINGE, PLASTIC (64950-353-01) | 50 pouch | 2020-12-01 | 0000-00-00 | No | No | Current |
| 64950-353-52 | 64950035352 | 50 POUCH in 1 CASE (64950-353-52) > 5 SYRINGE, PLASTIC in 1 POUCH (64950-353-92) > 1 mL in 1 SYRINGE, PLASTIC (64950-353-02) | 50 pouch | 2020-12-01 | 0000-00-00 | No | No | Current |
| 64950-353-91 | 64950035391 | 5 in 1 POUCH | | | | | | Historical |
| 64950-353-92 | 64950035392 | 5 in 1 POUCH | | | | | | Historical |