ACETAMINOPHEN AND CODEINE
- Product NDC
- 53489-161
- 11-digit product format
- 534890161
- Labeler code
- 53489
- Product ID
- 53489-161_57ee1a9a-25d6-41ea-b86c-b9cc5a8cebe6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Acetaminophen and Codeine Phosphate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Mutual Pharmaceutical Company, Inc.
- Application
- ANDA089673
- Marketing category
- ANDA
- Marketing start
- 1988-02-10
- 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]
- DEA schedule
- CIII
- 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 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 [MUTUAL PHARMACEUTICAL COMPANY, INC.] | 6 | |
| Codeine Phosphate | ACTIVE INGREDIENT | GSL05Y1MN6 | ACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.] | 6 | |
| Acetaminophen | ACTIVE MOIETY | 362O9ITL9D | ACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.] | 6 | |
| Codeine Anhydrous | ACTIVE MOIETY | UX6OWY2V7J | ACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.] | 6 | |
| cellulose, microcrystalline | INACTIVE INGREDIENT | OP1R32D61U | ACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.] | 6 | |
| croscarmellose sodium | INACTIVE INGREDIENT | M28OL1HH48 | ACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.] | 6 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | ACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.] | 6 | |
| Povidone K90 | INACTIVE INGREDIENT | RDH86HJV5Z | ACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.] | 6 | |
| sodium lauryl sulfate | INACTIVE INGREDIENT | 368GB5141J | ACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.] | 6 | |
| starch, corn | INACTIVE INGREDIENT | O8232NY3SJ | ACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.] | 6 | |
| stearic acid | INACTIVE INGREDIENT | 4ELV7Z65AP | ACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.] | 6 | |