ACETAMINOPHEN AND CODEINE PHOSPHATE
- Product NDC
- 53217-370
- 11-digit product format
- 532170370
- Labeler code
- 53217
- Product ID
- 53217-370_329e0451-ea99-45a1-9a89-a06d3de0c492
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- acetaminophen and codeine phosphate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aidarex Pharmaceuticals LLC
- Application
- ANDA040419
- Marketing category
- ANDA
- Marketing start
- 2018-04-03
- 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
- 2019-12-31
- 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 |
|---|
| 53217-370-20 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 20 in 1 BOTTLE | TABLET | 20 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53217-370 | ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [AIDAREX PHARMACEUTICALS LLC] | 1 | Legacy NDC, 1 package rows | 20180822_b2d0594b-c8df-4d29-8292-a1626bf09c1f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 53217-370-20 | 53217037020 | 20 in 1 BOTTLE | Historical |