Oxycodone and Acetaminophen
- Product NDC
- 12634-942
- 11-digit product format
- 126340942
- Labeler code
- 12634
- Product ID
- 12634-942_07f367ed-e5b9-40ec-b812-f5d5a5f7a774
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Oxycodone and Acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Apotheca, Inc
- Application
- ANDA040330
- Marketing category
- ANDA
- Marketing start
- 2007-07-23
- 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
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 12634-942-40 | Oxycodone and Acetaminophen | 40 in 1 BOTTLE | TABLET | 40 | | 1 |
| 12634-942-60 | Oxycodone and Acetaminophen | 60 in 1 BOTTLE | TABLET | 60 | | 1 |
| 12634-942-71 | Oxycodone and Acetaminophen | 30 in 1 BOTTLE | TABLET | 30 | | 1 |
| 12634-942-80 | Oxycodone and Acetaminophen | 20 in 1 BOTTLE | TABLET | 20 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| 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 Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 12634-942 | OXYCODONE AND ACETAMINOPHEN TABLET [APOTHECA, INC] | 1 | Legacy NDC, 4 package rows | 20131119_2426980d-f1b4-45d3-9d1a-156548a2c872.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 12634-942-40 | 12634094240 | 40 in 1 BOTTLE | Historical |
| 12634-942-60 | 12634094260 | 60 in 1 BOTTLE | Historical |
| 12634-942-71 | 12634094271 | 30 in 1 BOTTLE | Historical |
| 12634-942-80 | 12634094280 | 20 in 1 BOTTLE | Historical |