Guaifenesin and Dextromethorphan HBr
- Product NDC
- 71179-011
- 11-digit product format
- 711790011
- Labeler code
- 71179
- Product ID
- 71179-011_161614f9-ae67-454a-bf7f-dfc6ec40f8de
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Guaifenesin and Dextromethorphan HBr
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- VESPYR BRANDS LLC
- Application
- ANDA206941
- Marketing category
- ANDA
- Marketing start
- 2022-07-14
- 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 HBr
- 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 |
|---|
| 71179-011-21 | Guaifenesin and Dextromethorphan HBr | 7 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 7 | | 5 |
| 71179-011-21 | Guaifenesin and Dextromethorphan HBr | 3 in 1 CARTON | TABLET, EXTENDED RELEASE | 3 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71179-011 | GUAIFENESIN AND DEXTROMETHORPHAN HBR TABLET, EXTENDED RELEASE [VESPYR BRANDS, INC.] | 4 | Current NDC, Legacy NDC, 2 package rows | 20250408_1c8fbf40-17c1-4ee9-a2b9-ca4a08e08293.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 |
|---|
| 71179-011-21 | 71179001121 | 3 BLISTER PACK in 1 CARTON (71179-011-21) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | 3 blister pack | 2022-07-14 | 0000-00-00 | No | No | Current |