Acetaminophen and Codeine Phosphate
- Product NDC
- 45865-439
- 11-digit product format
- 458650439
- Labeler code
- 45865
- Product ID
- 45865-439_71c7a685-c60b-d801-e053-2a95a90aec5f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Acetaminophen and Codeine Phosphate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Medsource Pharmaceuticals
- Application
- ANDA202800
- Marketing category
- ANDA
- Marketing start
- 2013-04-15
- 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
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
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 |
|---|
| 45865-439-30 | Acetaminophen and Codeine Phosphate | 30 in 1 BOTTLE | TABLET | 30 | | 1 |
| 45865-439-60 | Acetaminophen and Codeine Phosphate | 60 in 1 BOTTLE | TABLET | 60 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 45865-439 | ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [MEDSOURCE PHARMACEUTICALS] | 1 | Legacy NDC, 2 package rows | 20180725_71c7a685-c60a-d801-e053-2a95a90aec5f.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 |
|---|
| 45865-439-30 | 45865043930 | 30 TABLET in 1 BOTTLE (45865-439-30) | 30 tablet | 2018-01-01 | 0000-00-00 | No | No | Current |
| 45865-439-60 | 45865043960 | 60 TABLET in 1 BOTTLE (45865-439-60) | 60 tablet | 2018-01-01 | 0000-00-00 | No | No | Current |