ACETAMINOPHEN AND CODEINE PHOSPHATE
- Product NDC
- 58118-4484
- 11-digit product format
- 581184484
- Labeler code
- 58118
- Product ID
- 58118-4484_0e76cd12-9f35-c98f-e063-6394a90ad9fb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- acetaminophen and codeine phosphate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Clinical Solutions Wholesale, LLC
- Application
- ANDA040419
- Marketing category
- ANDA
- Marketing start
- 2019-02-27
- 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 |
|---|
| 58118-4484-8 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 30 in 1 BLISTER PACK | TABLET | 30 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 58118-4484 | ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [CLINICAL SOLUTIONS WHOLESALE, LLC] | 5 | Current NDC, Legacy NDC, 1 package rows | 20240110_331d92ac-7287-47c7-b573-b5e6cd58c981.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 |
|---|
| 58118-4484-8 | 58118448408 | 30 TABLET in 1 BLISTER PACK (58118-4484-8) | 30 tablet | 2019-02-27 | 0000-00-00 | No | No | Current |