Oxycodone Hydrochloride
- Product NDC
- 64950-901
- 11-digit product format
- 649500901
- Labeler code
- 64950
- Product ID
- 64950-901_a1132aeb-1a6a-439b-9a33-812b901a511c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Oxycodone Hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Genus Lifesciences Inc.
- Application
- NDA200534
- Marketing category
- NDA
- Marketing start
- 2010-10-20
- Marketing end
- 0000-00-00
- Substance
- OXYCODONE HYDROCHLORIDE
- Active strength
- 5 mg/1
- Pharmacologic classes
- Full Opioid Agonists [MoA],Opioid Agonist [EPC]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Oxycodone Hydrochloride | ACTIVE INGREDIENT | C1ENJ2TE6C | OXYCODONE HYDROCHLORIDE CAPSULE [LEHIGH VALLEY TECHNOLOGIES, INC.] | 3 | |
| Oxycodone | ACTIVE MOIETY | CD35PMG570 | OXYCODONE HYDROCHLORIDE CAPSULE [LEHIGH VALLEY TECHNOLOGIES, INC.] | 3 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | OXYCODONE HYDROCHLORIDE CAPSULE [LEHIGH VALLEY TECHNOLOGIES, INC.] | 3 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | OXYCODONE HYDROCHLORIDE CAPSULE [LEHIGH VALLEY TECHNOLOGIES, INC.] | 3 | |
| COLLOIDAL SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | OXYCODONE HYDROCHLORIDE CAPSULE [LEHIGH VALLEY TECHNOLOGIES, INC.] | 3 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | OXYCODONE HYDROCHLORIDE CAPSULE [LEHIGH VALLEY TECHNOLOGIES, INC.] | 3 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | OXYCODONE HYDROCHLORIDE CAPSULE [LEHIGH VALLEY TECHNOLOGIES, INC.] | 3 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | OXYCODONE HYDROCHLORIDE CAPSULE [LEHIGH VALLEY TECHNOLOGIES, INC.] | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | OXYCODONE HYDROCHLORIDE CAPSULE [LEHIGH VALLEY TECHNOLOGIES, INC.] | 3 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | OXYCODONE HYDROCHLORIDE CAPSULE [LEHIGH VALLEY TECHNOLOGIES, INC.] | 3 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | OXYCODONE HYDROCHLORIDE CAPSULE [LEHIGH VALLEY TECHNOLOGIES, INC.] | 3 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | OXYCODONE HYDROCHLORIDE CAPSULE [LEHIGH VALLEY TECHNOLOGIES, INC.] | 3 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | OXYCODONE HYDROCHLORIDE CAPSULE [LEHIGH VALLEY TECHNOLOGIES, INC.] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 64950-901 | OXYCODONE HYDROCHLORIDE CAPSULE [GENUS LIFESCIENCES INC.] | 11 | Legacy NDC | 20240117_061cf52b-4432-422d-a97b-c3e1f8c4bab6.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 64950-901-10 | 64950090110 | 100 CAPSULE in 1 BOTTLE, PLASTIC (64950-901-10) | 100 capsule | 2010-10-20 | 0000-00-00 | No | No | Current |