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NDC 65162-0038-17 Guaifenesin and Dextromethorphan HBr 30; 600 mg/1; mg/1 Details
Guaifenesin and Dextromethorphan HBr 30; 600 mg/1; mg/1
Guaifenesin and Dextromethorphan HBr is a ORAL TABLET, EXTENDED RELEASE in the HUMAN OTC DRUG category. It is labeled and distributed by Amneal Pharmaceuticals LLC. The primary component is DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN.
MedlinePlus Drug Summary
Dextromethorphan is used to temporarily relieve cough caused by the common cold, the flu, or other conditions. Dextromethorphan will relieve a cough but will not treat the cause of the cough or speed recovery. Dextromethorphan is in a class of medications called antitussives. It works by decreasing activity in the part of the brain that causes coughing.
Related Packages: 65162-0038-17Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Dextromethorphan
Guaifenesin is used to relieve chest congestion. Guaifenesin may help control symptoms but does not treat the cause of symptoms or speed recovery. Guaifenesin is in a class of medications called expectorants. It works by thinning the mucus in the air passages to make it easier to cough up the mucus and clear the airways.
Related Packages: 65162-0038-17Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Guaifenesin
Product Information
| NDC | 65162-0038 |
|---|---|
| Product ID | 65162-038_bd665cf4-3a05-4f94-8161-2a4eb98e9c89 |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Guaifenesin and Dextromethorphan HBr |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Guaifenesin and Dextromethorphan HBr |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET, EXTENDED RELEASE |
| Route | ORAL |
| Active Ingredient Strength | 30; 600 |
| Active Ingredient Units | mg/1; mg/1 |
| Substance Name | DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN |
| Labeler Name | Amneal Pharmaceuticals LLC |
| Pharmaceutical Class | 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 Ant |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA209692 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 65162-0038-17 (65162003817)
| NDC Package Code | 65162-038-17 |
|---|---|
| Billing NDC | 65162003817 |
| Package | 2 BLISTER PACK in 1 CARTON (65162-038-17) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK |
| Marketing Start Date | 2018-11-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |