Roxicet
- Product NDC
- 0054-8650
- 11-digit product format
- 000548650
- Labeler code
- 0054
- Product ID
- 0054-8650_287496b8-2d45-4949-8194-d540281c2532
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Oxycodone and Acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- West-Ward Pharmaceuticals Corp
- Application
- ANDA087003
- Marketing category
- ANDA
- Marketing start
- 1987-03-11
- Marketing end
- 0000-00-00
- Substance
- OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN
- Active strength
- 5 mg/1; mg/1
- Pharmacologic classes
- Full Opioid Agonists [MoA],Opioid Agonist [EPC]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ACETAMINOPHEN | ACTIVE INGREDIENT | 362O9ITL9D | ROXICET (OXYCODONE AND ACETAMINOPHEN) TABLET ROXICET (OXYCODONE AND ACETAMINOPHEN) SOLUTION [ROXANE LABORATORIES, INC.] | 13 | |
| OXYCODONE HYDROCHLORIDE | ACTIVE INGREDIENT | C1ENJ2TE6C | ROXICET (OXYCODONE AND ACETAMINOPHEN) TABLET ROXICET (OXYCODONE AND ACETAMINOPHEN) SOLUTION [ROXANE LABORATORIES, INC.] | 13 | |
| ACETAMINOPHEN | ACTIVE MOIETY | 362O9ITL9D | ROXICET (OXYCODONE AND ACETAMINOPHEN) TABLET ROXICET (OXYCODONE AND ACETAMINOPHEN) SOLUTION [ROXANE LABORATORIES, INC.] | 13 | |
| OXYCODONE | ACTIVE MOIETY | CD35PMG570 | ROXICET (OXYCODONE AND ACETAMINOPHEN) TABLET ROXICET (OXYCODONE AND ACETAMINOPHEN) SOLUTION [ROXANE LABORATORIES, INC.] | 13 | |
| ALCOHOL | INACTIVE INGREDIENT | 3K9958V90M | ROXICET (OXYCODONE AND ACETAMINOPHEN) TABLET ROXICET (OXYCODONE AND ACETAMINOPHEN) SOLUTION [ROXANE LABORATORIES, INC.] | 13 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ROXICET (OXYCODONE AND ACETAMINOPHEN) TABLET ROXICET (OXYCODONE AND ACETAMINOPHEN) SOLUTION [ROXANE LABORATORIES, INC.] | 13 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | ROXICET (OXYCODONE AND ACETAMINOPHEN) TABLET ROXICET (OXYCODONE AND ACETAMINOPHEN) SOLUTION [ROXANE LABORATORIES, INC.] | 13 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | ROXICET (OXYCODONE AND ACETAMINOPHEN) TABLET ROXICET (OXYCODONE AND ACETAMINOPHEN) SOLUTION [ROXANE LABORATORIES, INC.] | 13 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | ROXICET (OXYCODONE AND ACETAMINOPHEN) TABLET ROXICET (OXYCODONE AND ACETAMINOPHEN) SOLUTION [ROXANE LABORATORIES, INC.] | 13 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | ROXICET (OXYCODONE AND ACETAMINOPHEN) TABLET ROXICET (OXYCODONE AND ACETAMINOPHEN) SOLUTION [ROXANE LABORATORIES, INC.] | 13 | |
| FRUCTOSE | INACTIVE INGREDIENT | 6YSS42VSEV | ROXICET (OXYCODONE AND ACETAMINOPHEN) TABLET ROXICET (OXYCODONE AND ACETAMINOPHEN) SOLUTION [ROXANE LABORATORIES, INC.] | 13 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | ROXICET (OXYCODONE AND ACETAMINOPHEN) TABLET ROXICET (OXYCODONE AND ACETAMINOPHEN) SOLUTION [ROXANE LABORATORIES, INC.] | 13 | |
| POTASSIUM SORBATE | INACTIVE INGREDIENT | 1VPU26JZZ4 | ROXICET (OXYCODONE AND ACETAMINOPHEN) TABLET ROXICET (OXYCODONE AND ACETAMINOPHEN) SOLUTION [ROXANE LABORATORIES, INC.] | 13 | |
| SACCHARIN SODIUM | INACTIVE INGREDIENT | SB8ZUX40TY | ROXICET (OXYCODONE AND ACETAMINOPHEN) TABLET ROXICET (OXYCODONE AND ACETAMINOPHEN) SOLUTION [ROXANE LABORATORIES, INC.] | 13 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | ROXICET (OXYCODONE AND ACETAMINOPHEN) TABLET ROXICET (OXYCODONE AND ACETAMINOPHEN) SOLUTION [ROXANE LABORATORIES, INC.] | 13 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | ROXICET (OXYCODONE AND ACETAMINOPHEN) TABLET ROXICET (OXYCODONE AND ACETAMINOPHEN) SOLUTION [ROXANE LABORATORIES, INC.] | 13 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | ROXICET (OXYCODONE AND ACETAMINOPHEN) TABLET ROXICET (OXYCODONE AND ACETAMINOPHEN) SOLUTION [ROXANE LABORATORIES, INC.] | 13 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0054-8650 | ROXICET (OXYCODONE AND ACETAMINOPHEN) TABLET ROXICET (OXYCODONE AND ACETAMINOPHEN) SOLUTION [WEST-WARD PHARMACEUTICALS CORP] | 14 | Legacy NDC | 20160812_86817b05-450c-4af0-aeea-acba2ac00601.zip |