Oxycodone and Acetaminophen
- Product NDC
- 10544-621
- 11-digit product format
- 105440621
- Labeler code
- 10544
- Product ID
- 10544-621_b93cc1aa-1a9a-4e1a-9f2e-a02bf14c4ff1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Oxycodone and Acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Blenheim Pharmacal, Inc.
- Application
- ANDA040777
- Marketing category
- ANDA
- Marketing start
- 2010-05-17
- Marketing end
- 0000-00-00
- Substance
- OXYCODONE; ACETAMINOPHEN
- Active strength
- 5 mg/1; mg/1
- Pharmacologic classes
- Full Opioid Agonists [MoA],Opioid Agonist [EPC]
- DEA schedule
- CII
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- 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 |
|---|
| 10544-621-06 | Oxycodone and Acetaminophen | 6 in 1 BOTTLE | TABLET | 6 | | 1 |
| 10544-621-10 | Oxycodone and Acetaminophen | 10 in 1 BOTTLE | TABLET | 10 | | 1 |
| 10544-621-15 | Oxycodone and Acetaminophen | 15 in 1 BOTTLE | TABLET | 15 | | 1 |
| 10544-621-20 | Oxycodone and Acetaminophen | 20 in 1 BOTTLE | TABLET | 20 | | 1 |
| 10544-621-30 | Oxycodone and Acetaminophen | 30 in 1 BOTTLE | TABLET | 30 | | 1 |
| 10544-621-50 | Oxycodone and Acetaminophen | 50 in 1 BOTTLE | TABLET | 50 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ACETAMINOPHEN | ACTIVE INGREDIENT | 362O9ITL9D | OXYCODONE AND ACETAMINOPHEN TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| OXYCODONE | ACTIVE INGREDIENT | CD35PMG570 | OXYCODONE AND ACETAMINOPHEN TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| ACETAMINOPHEN | ACTIVE MOIETY | 362O9ITL9D | OXYCODONE AND ACETAMINOPHEN TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| OXYCODONE | ACTIVE MOIETY | CD35PMG570 | OXYCODONE AND ACETAMINOPHEN TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | OXYCODONE AND ACETAMINOPHEN TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | OXYCODONE AND ACETAMINOPHEN TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | OXYCODONE AND ACETAMINOPHEN TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | OXYCODONE AND ACETAMINOPHEN TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | OXYCODONE AND ACETAMINOPHEN TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | OXYCODONE AND ACETAMINOPHEN TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | OXYCODONE AND ACETAMINOPHEN TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 10544-621 | OXYCODONE AND ACETAMINOPHEN TABLET [BLENHEIM PHARMACAL, INC.] | 1 | Legacy NDC, 6 package rows | 20101018_26c17ac7-64f4-436b-a56d-38d4584959e8.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 10544-621-06 | 10544062106 | 6 in 1 BOTTLE | Historical |
| 10544-621-10 | 10544062110 | 10 in 1 BOTTLE | Historical |
| 10544-621-15 | 10544062115 | 15 in 1 BOTTLE | Historical |
| 10544-621-20 | 10544062120 | 20 in 1 BOTTLE | Historical |
| 10544-621-30 | 10544062130 | 30 in 1 BOTTLE | Historical |
| 10544-621-50 | 10544062150 | 50 in 1 BOTTLE | Historical |