Guaifenesin and Dextromethorphan HBR
- Product NDC
- 51316-009
- 11-digit product format
- 513160009
- Labeler code
- 51316
- Product ID
- 51316-009_2885f0f5-e5ad-b667-c442-753a48d3f900
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Guaifenesin and Dextromethorphan HBR
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- CVS Pharmacy
- Application
- ANDA217340
- Marketing category
- ANDA
- Marketing start
- 2023-08-15
- Substance
- DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
- Active strength
- 30; 600 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
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 9D2RTI9KYH | DEXTROMETHORPHAN HYDROBROMIDE | 6700-34-1 | DEXTROMETHORPHAN HYDROBROMIDE |
| 495W7451VQ | GUAIFENESIN | 93-14-1 | GUAIFENESIN |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 51316-009-01 | 51316000901 | 5 BLISTER PACK in 1 CARTON (51316-009-01) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | 5 blister pack | 2023-08-15 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Drug Facts | CVS Pharmacy | 2024-11-10 | HUMAN OTC DRUG LABEL | 4 |