Oxycodone and Acetaminophen
- Product NDC
- 0603-4998
- 11-digit product format
- 006034998
- Labeler code
- 0603
- Product ID
- 0603-4998_d09ffa34-f5bd-44c4-816d-67b2d6a27122
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Oxycodone hydrochloride and Acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Par Pharmaceutical
- Application
- ANDA040105
- Marketing category
- ANDA
- Marketing start
- 1996-07-30
- 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
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ACETAMINOPHEN | ACTIVE INGREDIENT | 362O9ITL9D | OXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [REBEL DISTRIBUTORS CORP] | 3 | |
| OXYCODONE HYDROCHLORIDE | ACTIVE INGREDIENT | C1ENJ2TE6C | OXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [REBEL DISTRIBUTORS CORP] | 3 | |
| ACETAMINOPHEN | ACTIVE MOIETY | 362O9ITL9D | OXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [REBEL DISTRIBUTORS CORP] | 3 | |
| OXYCODONE | ACTIVE MOIETY | CD35PMG570 | OXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [REBEL DISTRIBUTORS CORP] | 3 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | OXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [REBEL DISTRIBUTORS CORP] | 3 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | OXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [REBEL DISTRIBUTORS CORP] | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | OXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [REBEL DISTRIBUTORS CORP] | 3 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | OXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [REBEL DISTRIBUTORS CORP] | 3 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | OXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [REBEL DISTRIBUTORS CORP] | 3 | |
| STARCH, PREGELATINIZED CORN | INACTIVE INGREDIENT | O8232NY3SJ | OXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [REBEL DISTRIBUTORS CORP] | 3 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | OXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [REBEL DISTRIBUTORS CORP] | 3 | |
| ACETAMINOPHEN | ACTIVE INGREDIENT | 362O9ITL9D | OXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [H.J. HARKINS COMPANY, INC.] | 2 | |
| ACETAMINOPHEN | ACTIVE INGREDIENT | 362O9ITL9D | OXYCODONE AND ACETAMINOPHEN TABLET [DIRECTRX] | 2 | |
| OXYCODONE HYDROCHLORIDE | ACTIVE INGREDIENT | C1ENJ2TE6C | OXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [H.J. HARKINS COMPANY, INC.] | 2 | |
| OXYCODONE HYDROCHLORIDE | ACTIVE INGREDIENT | C1ENJ2TE6C | OXYCODONE AND ACETAMINOPHEN TABLET [DIRECTRX] | 2 | |
| ACETAMINOPHEN | ACTIVE MOIETY | 362O9ITL9D | OXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [H.J. HARKINS COMPANY, INC.] | 2 | |
| ACETAMINOPHEN | ACTIVE MOIETY | 362O9ITL9D | OXYCODONE AND ACETAMINOPHEN TABLET [DIRECTRX] | 2 | |
| OXYCODONE | ACTIVE MOIETY | CD35PMG570 | OXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [H.J. HARKINS COMPANY, INC.] | 2 | |
| OXYCODONE | ACTIVE MOIETY | CD35PMG570 | OXYCODONE AND ACETAMINOPHEN TABLET [DIRECTRX] | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | OXYCODONE AND ACETAMINOPHEN TABLET [DIRECTRX] | 2 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | OXYCODONE AND ACETAMINOPHEN TABLET [DIRECTRX] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | OXYCODONE AND ACETAMINOPHEN TABLET [DIRECTRX] | 2 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | OXYCODONE AND ACETAMINOPHEN TABLET [DIRECTRX] | 2 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | OXYCODONE AND ACETAMINOPHEN TABLET [DIRECTRX] | 2 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | OXYCODONE AND ACETAMINOPHEN TABLET [DIRECTRX] | 2 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | OXYCODONE AND ACETAMINOPHEN TABLET [DIRECTRX] | 2 | |
| ACETAMINOPHEN | ACTIVE INGREDIENT | 362O9ITL9D | OXYCODONE AND ACETAMINOPHEN TABLET [APOTHECA, INC] | 1 | |
| OXYCODONE HYDROCHLORIDE | ACTIVE INGREDIENT | C1ENJ2TE6C | OXYCODONE AND ACETAMINOPHEN TABLET [APOTHECA, INC] | 1 | |
| acetaminophen | ACTIVE MOIETY | 362O9ITL9D | OXYCODONE AND ACETAMINOPHEN TABLET [APOTHECA, INC] | 1 | |
| OXYCODONE | ACTIVE MOIETY | CD35PMG570 | OXYCODONE AND ACETAMINOPHEN TABLET [APOTHECA, INC] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | OXYCODONE AND ACETAMINOPHEN TABLET [APOTHECA, INC] | 1 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | OXYCODONE AND ACETAMINOPHEN TABLET [APOTHECA, INC] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | OXYCODONE AND ACETAMINOPHEN TABLET [APOTHECA, INC] | 1 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | OXYCODONE AND ACETAMINOPHEN TABLET [APOTHECA, INC] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | OXYCODONE AND ACETAMINOPHEN TABLET [APOTHECA, INC] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | OXYCODONE AND ACETAMINOPHEN TABLET [APOTHECA, INC] | 1 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | OXYCODONE AND ACETAMINOPHEN TABLET [APOTHECA, INC] | 1 | |
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 |
|---|
| 0603-4998-21 | 00603499821 | 100 TABLET in 1 BOTTLE, PLASTIC (0603-4998-21) | 100 tablet | 1996-07-30 | 0000-00-00 | No | No | Current |
| 0603-4998-28 | 00603499828 | 500 TABLET in 1 BOTTLE, PLASTIC (0603-4998-28) | 500 tablet | 1996-07-30 | 0000-00-00 | No | No | Current |