ACETAMINOPHEN AND CODEINE PHOSPHATE
- Product NDC
- 58118-0485
- 11-digit product format
- 581180485
- Labeler code
- 58118
- Product ID
- 58118-0485_0e85c22f-4438-16b4-e063-6394a90a8600
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- acetaminophen and codeine phosphate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Clinical Solutions Wholesale, LLC
- Application
- ANDA040419
- Marketing category
- ANDA
- Marketing start
- 2001-05-31
- 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 |
|---|
| 58118-0485-8 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 30 in 1 BLISTER PACK | TABLET | 30 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 58118-0485 | ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [CLINICAL SOLUTIONS WHOLESALE, LLC] | 3 | Current NDC, Legacy NDC, 1 package rows | 20240110_5603ed2f-0b6c-46fd-8c76-c4e4d188a343.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 |
|---|
| 58118-0485-8 | 58118048508 | 30 TABLET in 1 BLISTER PACK (58118-0485-8) | 30 tablet | 2021-11-12 | 0000-00-00 | No | No | Current |