Acetaminophen and Codeine Phosphate
- Product NDC
- 64950-374
- 11-digit product format
- 649500374
- Labeler code
- 64950
- Product ID
- 64950-374_87cb7b3c-3ed5-4a40-a486-7713bb2b6e3e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Acetaminophen and Codeine Phosphate
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Genus Lifesciences Inc.
- Application
- ANDA087508
- Marketing category
- ANDA
- Marketing start
- 2023-08-10
- Substance
- ACETAMINOPHEN; CODEINE PHOSPHATE
- Active strength
- 120; 12 mg/5mL; mg/5mL
- Pharmacologic classes
- Full Opioid Agonists [MoA], Opioid Agonist [EPC]
- DEA schedule
- CV
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Acetaminophen and Codeine Phosphate
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ACETAMINOPHEN | 120 mg/5mL |
| CODEINE PHOSPHATE | 12 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 362O9ITL9D, GSL05Y1MN6 |
| Rxcui | 993755 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 64950-374-04 | Acetaminophen and Codeine Phosphate | 118 mL in 1 BOTTLE, PLASTIC | SOLUTION | 118 | | 4 |
| 64950-374-16 | Acetaminophen and Codeine Phosphate | 473 mL in 1 BOTTLE, PLASTIC | SOLUTION | 473 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 64950-374 | ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [GENUS LIFESCIENCES INC.] | 3 | Current NDC, 2 package rows | 20240810_95a5d638-3072-4c37-a4cd-f8550328e2c6.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 64950-374-04 | 64950037404 | 118 mL in 1 BOTTLE, PLASTIC (64950-374-04) | 118 ml | 2023-08-10 | No | No | Current |
| 64950-374-16 | 64950037416 | 473 mL in 1 BOTTLE, PLASTIC (64950-374-16) | 473 ml | 2023-08-10 | No | No | Current |