ACETAMINOPHEN AND CODEINE PHOSPHATE
- Product NDC
- 70518-2628
- 11-digit product format
- 705182628
- Labeler code
- 70518
- Product ID
- 70518-2628_4e3dcc93-c0ce-bfc6-e063-6294a90adbfd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- acetaminophen and codeine phosphate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA211610
- Marketing category
- ANDA
- Marketing start
- 2020-03-12
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ACETAMINOPHEN AND CODEINE PHOSPHATE
- Listing expiration
- 2027-12-31
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#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-2628-0 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 30 in 1 BLISTER PACK | TABLET | 30 | | 12 |
| 70518-2628-1 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 30 in 1 BLISTER PACK | TABLET | 30 | | 12 |
| 70518-2628-2 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 60 in 1 BOTTLE, PLASTIC | TABLET | 60 | | 12 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-2628 | ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [REMEDYREPACK INC.] | 8 | Current NDC, Legacy NDC, 3 package rows | 20250326_1fe39679-fd58-4d2c-ba61-49d492a2b087.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 |
|---|
| 70518-2628-0 | 70518262800 | 30 TABLET in 1 BLISTER PACK (70518-2628-0) | 30 tablet | 2020-03-12 | 0000-00-00 | No | No | Current |
| 70518-2628-1 | 70518262801 | 30 in 1 BLISTER PACK | | | | | | Historical |
| 70518-2628-2 | 70518262802 | 60 TABLET in 1 BOTTLE, PLASTIC (70518-2628-2) | 60 tablet | 2025-06-17 | | No | No | Current |