Tuxarin
- Product NDC
- 71269-040
- 11-digit product format
- 712690040
- Labeler code
- 71269
- Product ID
- 71269-040_c64324ef-f77f-4467-844a-711a6b305582
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- codeine phosphate and chlorpheniramine maleate
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Mainpointe Pharmaceuticals
- Application
- NDA206323
- Marketing category
- NDA
- Marketing start
- 2018-10-15
- Substance
- CHLORPHENIRAMINE MALEATE; CODEINE PHOSPHATE
- Active strength
- 8; 54.3 mg/1; mg/1
- Pharmacologic classes
- Full Opioid Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], 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
- Tuxarin
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CHLORPHENIRAMINE MALEATE | 8 mg/1 |
| CODEINE PHOSPHATE | 54.3 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | V1Q0O9OJ9Z, GSL05Y1MN6 |
| Rxcui | 1664543, 2099286 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 71269-040-10 | 2023-06-22 | C162847 | 48780-1 | ba0f9c33-47fa-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use TUXARIN ER™ safely and effectively. See full prescribing information for TUXARIN ER. TUXARIN ER (codeine phosphate and chlorpheniramine maleate) extended-release tablets, for oral use, CIII Initial U.S. Approval: 1985 |
| 71269-040-30 | 2023-06-22 | C162847 | 48780-1 | ba0f9c33-47fa-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use TUXARIN ER™ safely and effectively. See full prescribing information for TUXARIN ER. TUXARIN ER (codeine phosphate and chlorpheniramine maleate) extended-release tablets, for oral use, CIII Initial U.S. Approval: 1985 |
| 71269-040-10 | 2023-01-30 | C162847 | 48780-1 | ba0f9c33-47fa-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use TUXARIN ER™ safely and effectively. See full prescribing information for TUXARIN ER. TUXARIN ER (codeine phosphate and chlorpheniramine maleate) extended-release tablets, for oral use, CIII Initial U.S. Approval: 1985 |
| 71269-040-30 | 2023-01-30 | C162847 | 48780-1 | ba0f9c33-47fa-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use TUXARIN ER™ safely and effectively. See full prescribing information for TUXARIN ER. TUXARIN ER (codeine phosphate and chlorpheniramine maleate) extended-release tablets, for oral use, CIII Initial U.S. Approval: 1985 |
| 71269-040-10 | 2021-11-18 | C162847 | 48780-1 | ba0f9c33-47fa-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use TUXARIN ER™ safely and effectively. See full prescribing information for TUXARIN ER. TUXARIN ER (codeine phosphate and chlorpheniramine maleate) extended-release tablets, for oral use, CIII Initial U.S. Approval: 1985 |
| 71269-040-10 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-47fa-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use TUXARIN ER™ safely and effectively. See full prescribing information for TUXARIN ER. TUXARIN ER (codeine phosphate and chlorpheniramine maleate) extended-release tablets, for oral use, CIII Initial U.S. Approval: 1985 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71269-040-10 | Tuxarin | 100 in 1 BOTTLE, PLASTIC | TABLET, EXTENDED RELEASE | 100 | | 6 |
| 71269-040-30 | Tuxarin | 30 in 1 BOTTLE, PLASTIC | TABLET, EXTENDED RELEASE | 30 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71269-040 | TUXARIN (CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE) TABLET, EXTENDED RELEASE [MAINPOINTE PHARMACEUTICALS] | 6 | Current NDC, Legacy NDC, 2 package rows | 20240119_a7cfab67-6087-4ab4-b7cd-4f9295413180.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 71269-040-10 | 71269004010 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71269-040-10) | 2018-10-15 | 0000-00-00 | No | No | Current |
| 71269-040-30 | 71269004030 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71269-040-30) | 2018-10-15 | 0000-00-00 | No | No | Current |