ACETAMINOPHEN AND CODEINE PHOSPHATE
- Product NDC
- 68071-3651
- 11-digit product format
- 680713651
- Labeler code
- 68071
- Product ID
- 68071-3651_1e020e6c-dddf-f5d3-e063-6294a90a5241
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- acetaminophen and codeine phosphate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals, Inc.
- Application
- ANDA211610
- Marketing category
- ANDA
- Marketing start
- 2019-08-02
- Substance
- ACETAMINOPHEN; CODEINE PHOSPHATE
- Active strength
- 300; 30 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
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68071-3651-6 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 6 in 1 BOTTLE | TABLET | 6 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-3651 | ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [NUCARE PHARMACEUTICALS, INC.] | 1 | Current NDC, 1 package rows | 20240725_1e01f923-38c1-9b59-e063-6394a90a22f1.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 |
|---|
| 68071-3651-6 | 68071365106 | 6 TABLET in 1 BOTTLE (68071-3651-6) | 6 tablet | 2024-07-24 | No | No | Historical |