Acetaminophen and Codeine Phosphate
- Product NDC
- 72189-376
- 11-digit product format
- 721890376
- Labeler code
- 72189
- Product ID
- 72189-376_2c4cbd73-cdae-14f5-e063-6294a90ab38e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Acetaminophen and Codeine Phosphate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Direct_Rx
- Application
- ANDA040419
- Marketing category
- ANDA
- Marketing start
- 2022-08-31
- Substance
- ACETAMINOPHEN; CODEINE PHOSPHATE
- Active strength
- 300; 60 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 | 60 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 362O9ITL9D, GSL05Y1MN6 |
| Rxcui | 993890 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72189-376-60 | Acetaminophen and Codeine Phosphate | 60 in 1 BOTTLE | TABLET | 60 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72189-376 | ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [DIRECT_RX] | 2 | Current NDC, Legacy NDC, 1 package rows | 20250123_e78e50c0-36da-528e-e053-2995a90a3d80.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 |
|---|
| 72189-376-60 | 72189037660 | 60 TABLET in 1 BOTTLE (72189-376-60) | 60 tablet | 2022-08-31 | 0000-00-00 | No | No | Current |