Guaifenesin and Dextromethorphan Hydrobromide
- Product NDC
- 51316-600
- 11-digit product format
- 513160600
- Labeler code
- 51316
- Product ID
- 51316-600_4fe39452-8d46-ba50-e063-6294a90ac53a
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Guaifenesin and Dextromethorphan Hydrobromide
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- CVS PHARMACY, INC
- Application
- ANDA214781
- Marketing category
- ANDA
- Marketing start
- 2022-04-19
- Substance
- DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
- Active strength
- 60; 1200 mg/1; mg/1
- Pharmacologic classes
- Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Guaifenesin and Dextromethorphan Hydrobromide
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DEXTROMETHORPHAN HYDROBROMIDE | 60 mg/1 |
| GUAIFENESIN | 1200 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9D2RTI9KYH, 495W7451VQ |
| Rxcui | 1099074 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51316-600-70 | Guaifenesin and Dextromethorphan Hydrobromide | 5 in 1 CARTON | TABLET, EXTENDED RELEASE | 5 | | 5 |
| 51316-600-70 | Guaifenesin and Dextromethorphan Hydrobromide | 14 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 14 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51316-600 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE TABLET, EXTENDED RELEASE [CVS PHARMACY, INC] | 3 | Current NDC, Legacy NDC, 2 package rows | 20220422_dd00dfc0-e523-4dec-8fc0-50363eadec57.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 |
|---|
| 51316-600-70 | 51316060070 | 5 BLISTER PACK in 1 CARTON (51316-600-70) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | 5 blister pack | 2022-04-19 | 0000-00-00 | No | No | Current |