ACETAMINOPHEN AND CODEINE PHOSPHATE
- Product NDC
- 68071-3658
- 11-digit product format
- 680713658
- Labeler code
- 68071
- Product ID
- 68071-3658_2baebda6-c349-721c-e063-6394a90a3552
- 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
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 | 30 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 362O9ITL9D, GSL05Y1MN6 |
| Rxcui | 993781 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68071-3658-2 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 20 in 1 BOTTLE | TABLET | 20 | | 3 |
| 68071-3658-3 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 30 in 1 BOTTLE | TABLET | 30 | | 3 |
| 68071-3658-5 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 15 in 1 BOTTLE | TABLET | 15 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-3658 | ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [NUCARE PHARMACEUTICALS, INC.] | 3 | Current NDC, 3 package rows | 20250116_1e932a34-a7d3-e4ec-e063-6294a90a25b1.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 |
|---|
| 68071-3658-2 | 68071365802 | 20 TABLET in 1 BOTTLE (68071-3658-2) | 20 tablet | 2025-01-14 | No | No | Current |
| 68071-3658-3 | 68071365803 | 30 TABLET in 1 BOTTLE (68071-3658-3) | 30 tablet | 2024-07-31 | No | No | Current |
| 68071-3658-5 | 68071365805 | 15 TABLET in 1 BOTTLE (68071-3658-5) | 15 tablet | 2024-07-31 | No | No | Current |