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NDC 65162-0037-28 Guaifenesin 1200 mg/1 Details
Guaifenesin 1200 mg/1
Guaifenesin 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 GUAIFENESIN.
MedlinePlus Drug Summary
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: 65162-0037-28Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Guaifenesin
Product Information
| NDC | 65162-0037 |
|---|---|
| Product ID | 65162-037_b58f3f20-7c61-4825-bd4a-99f142fde719 |
| 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 |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Guaifenesin |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET, EXTENDED RELEASE |
| Route | ORAL |
| Active Ingredient Strength | 1200 |
| Active Ingredient Units | mg/1 |
| Substance Name | GUAIFENESIN |
| Labeler Name | Amneal Pharmaceuticals LLC |
| Pharmaceutical Class | Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA207342 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 65162-0037-28 (65162003728)
| NDC Package Code | 65162-037-28 |
|---|---|
| Billing NDC | 65162003728 |
| Package | 2 BLISTER PACK in 1 CARTON (65162-037-28) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK |
| Marketing Start Date | 2018-07-27 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |