Acetaminophen and Codeine
- Product NDC
- 10544-100
- 11-digit product format
- 105440100
- Labeler code
- 10544
- Product ID
- 10544-100_21c498e0-47f1-4958-9126-86ddde5f2d78
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- acetaminophen and codeine phosphate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Blenheim Pharmacal, Inc.
- Application
- ANDA089805
- Marketing category
- ANDA
- Marketing start
- 2013-11-11
- Marketing end
- 0000-00-00
- Substance
- ACETAMINOPHEN; CODEINE PHOSPHATE
- Active strength
- 300 mg/1; mg/1
- Pharmacologic classes
- Full Opioid Agonists [MoA],Opioid Agonist [EPC]
- 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 |
|---|
| 10544-100-10 | Acetaminophen and Codeine | 10 in 1 BOTTLE | TABLET | 10 | | 4 |
| 10544-100-15 | Acetaminophen and Codeine | 15 in 1 BOTTLE | TABLET | 15 | | 4 |
| 10544-100-20 | Acetaminophen and Codeine | 20 in 1 BOTTLE | TABLET | 20 | | 4 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ACETAMINOPHEN | ACTIVE INGREDIENT | 362O9ITL9D | ACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [BLENHEIM PHARMACAL, INC.] | 4 | |
| CODEINE PHOSPHATE | ACTIVE INGREDIENT | GSL05Y1MN6 | ACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [BLENHEIM PHARMACAL, INC.] | 4 | |
| ACETAMINOPHEN | ACTIVE MOIETY | 362O9ITL9D | ACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [BLENHEIM PHARMACAL, INC.] | 4 | |
| CODEINE ANHYDROUS | ACTIVE MOIETY | UX6OWY2V7J | ACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [BLENHEIM PHARMACAL, INC.] | 4 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [BLENHEIM PHARMACAL, INC.] | 4 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [BLENHEIM PHARMACAL, INC.] | 4 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | ACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [BLENHEIM PHARMACAL, INC.] | 4 | |
| SODIUM METABISULFITE | INACTIVE INGREDIENT | 4VON5FNS3C | ACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [BLENHEIM PHARMACAL, INC.] | 4 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | ACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [BLENHEIM PHARMACAL, INC.] | 4 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | ACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [BLENHEIM PHARMACAL, INC.] | 4 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | ACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [BLENHEIM PHARMACAL, INC.] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 10544-100 | ACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [BLENHEIM PHARMACAL, INC.] | 4 | Legacy NDC, 3 package rows | 20140616_fdea5078-b6d3-4c2b-981b-398bb1fadc40.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 10544-100-10 | 10544010010 | 10 in 1 BOTTLE | Historical |
| 10544-100-15 | 10544010015 | 15 in 1 BOTTLE | Historical |
| 10544-100-20 | 10544010020 | 20 in 1 BOTTLE | Historical |