Roxicodone
- Product NDC
- 23635-582
- 11-digit product format
- 236350582
- Labeler code
- 23635
- Product ID
- 23635-582_9c646c9c-3074-4250-8191-82ac61b515a4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- oxycodone hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- SpecGx LLC
- Application
- NDA021011
- Marketing category
- NDA
- Marketing start
- 2000-08-31
- Substance
- OXYCODONE HYDROCHLORIDE
- Active strength
- 30 mg/1
- 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
- Roxicodone
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| OXYCODONE HYDROCHLORIDE | 30 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | C1ENJ2TE6C |
| Rxcui | 1049611, 1049613, 1049618, 1049620 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 23635-582-10 | Roxicodone | 100 in 1 BOTTLE, PLASTIC | TABLET | 100 | | 30 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| OXYCODONE HYDROCHLORIDE | ACTIVE INGREDIENT | C1ENJ2TE6C | ROXICODONE (OXYCODONE HYDROCHLORIDE) TABLET [MALLINCKRODT, INC] | 4 | |
| OXYCODONE | ACTIVE MOIETY | CD35PMG570 | ROXICODONE (OXYCODONE HYDROCHLORIDE) TABLET [MALLINCKRODT, INC] | 4 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ROXICODONE (OXYCODONE HYDROCHLORIDE) TABLET [MALLINCKRODT, INC] | 4 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | ROXICODONE (OXYCODONE HYDROCHLORIDE) TABLET [MALLINCKRODT, INC] | 4 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | ROXICODONE (OXYCODONE HYDROCHLORIDE) TABLET [MALLINCKRODT, INC] | 4 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | ROXICODONE (OXYCODONE HYDROCHLORIDE) TABLET [MALLINCKRODT, INC] | 4 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | ROXICODONE (OXYCODONE HYDROCHLORIDE) TABLET [MALLINCKRODT, INC] | 4 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | ROXICODONE (OXYCODONE HYDROCHLORIDE) TABLET [MALLINCKRODT, INC] | 4 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | ROXICODONE (OXYCODONE HYDROCHLORIDE) TABLET [MALLINCKRODT, INC] | 4 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | ROXICODONE (OXYCODONE HYDROCHLORIDE) TABLET [MALLINCKRODT, INC] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 23635-582 | ROXICODONE (OXYCODONE HYDROCHLORIDE) TABLET [SPECGX LLC] | 28 | Current NDC, Legacy NDC, 1 package rows | 20240426_5a8157d3-ba20-4abf-b0d4-6ad141b31d63.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 |
|---|
| 23635-582-10 | 23635058210 | 100 TABLET in 1 BOTTLE, PLASTIC (23635-582-10) | 100 tablet | 2000-08-31 | 0000-00-00 | No | No | Current |