ACETAMINOPHEN AND CODEINE PHOSPHATE
- Product NDC
- 68071-4533
- 11-digit product format
- 680714533
- Labeler code
- 68071
- Product ID
- 68071-4533_2d53b71b-7709-e12d-e063-6294a90a5478
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- acetaminophen and codeine phosphate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA040419
- Marketing category
- ANDA
- Marketing start
- 2011-07-06
- Substance
- ACETAMINOPHEN; CODEINE PHOSPHATE
- Active strength
- 300; 30 mg/1; mg/1
- Pharmacologic classes
- Full Opioid Agonists [MoA], Opioid Agonist [EPC]
- DEA schedule
- CIII
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ACETAMINOPHEN AND CODEINE PHOSPHATE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ACETAMINOPHEN | 300 mg/1 |
| CODEINE PHOSPHATE | 30 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 362O9ITL9D, GSL05Y1MN6 |
| Rxcui | 993781 |
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 |
|---|
| 68071-4533-2 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 20 in 1 BOTTLE | TABLET | 20 | | 5 |
| 68071-4533-3 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 30 in 1 BOTTLE | TABLET | 30 | | 5 |
| 68071-4533-4 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 24 in 1 BOTTLE | TABLET | 24 | | 5 |
| 68071-4533-5 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 15 in 1 BOTTLE | TABLET | 15 | | 5 |
| 68071-4533-6 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 60 in 1 BOTTLE | TABLET | 60 | | 5 |
| 68071-4533-8 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 84 in 1 BOTTLE | TABLET | 84 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-4533 | ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [NUCARE PHARMACEUTICALS,INC.] | 5 | Current NDC, Legacy NDC, 6 package rows | 20250206_73e2086e-f513-537f-e053-2991aa0a1348.zip |
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 |
|---|
| 68071-4533-2 | 68071453302 | 20 TABLET in 1 BOTTLE (68071-4533-2) | 20 tablet | 2018-08-20 | 0000-00-00 | No | No | Current |
| 68071-4533-3 | 68071453303 | 30 TABLET in 1 BOTTLE (68071-4533-3) | 30 tablet | 2018-08-20 | 0000-00-00 | No | No | Current |
| 68071-4533-4 | 68071453304 | 24 TABLET in 1 BOTTLE (68071-4533-4) | 24 tablet | 2018-08-20 | 0000-00-00 | No | No | Current |
| 68071-4533-5 | 68071453305 | 15 TABLET in 1 BOTTLE (68071-4533-5) | 15 tablet | 2018-08-20 | 0000-00-00 | No | No | Current |
| 68071-4533-6 | 68071453306 | 60 TABLET in 1 BOTTLE (68071-4533-6) | 60 tablet | 2018-08-20 | 0000-00-00 | No | No | Current |
| 68071-4533-8 | 68071453308 | 84 TABLET in 1 BOTTLE (68071-4533-8) | 84 tablet | 2018-08-20 | 0000-00-00 | No | No | Current |