guaifenesin and dextromethorphan hbr (65162-039)

Drug Facts

Product Profile

Brand Name guaifenesin and dextromethorphan hbr

Generic Name guaifenesin and dextromethorphan hbr

Labeler amneal pharmaceuticals llc

Dosage Form TABLET, EXTENDED RELEASE

Routes

ORAL

Active Ingredients

dextromethorphan hydrobromide 60 mg/1, guaifenesin 1200 mg/1

Manufacturer

Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 65162-039

Product ID 65162-039_bdfe8cad-61bb-48eb-a5c4-ec21abde055a

Product Type HUMAN OTC DRUG

Marketing Category ANDA

Application Number ANDA209692

Listing Expiration 2026-12-31

Marketing Start 2018-11-01

Pharmacologic Class

Established (EPC)

expectorant [epc]

Physiologic Effect

decreased respiratory secretion viscosity [pe] increased respiratory secretions [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65162039

Hyphenated Format 65162-039

Supplemental Identifiers

RxCUI

1099074

UPC

0365162039030

UNII

9D2RTI9KYH 495W7451VQ

NUI

N0000193956 N0000008867 N0000009560

Packaging Origin

Original Packager

true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name guaifenesin and dextromethorphan hbr (source: ndc)

Generic Name guaifenesin and dextromethorphan hbr (source: ndc)

Application Number ANDA209692 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

60 mg/1
1200 mg/1

source: ndc

Packaging

1 BOTTLE in 1 CARTON (65162-039-03) / 30 TABLET, EXTENDED RELEASE in 1 BOTTLE
1 BOTTLE in 1 CARTON (65162-039-06) / 60 TABLET, EXTENDED RELEASE in 1 BOTTLE
2 BLISTER PACK in 1 CARTON (65162-039-17) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

source: ndc

Packages (3)

65162-039-03 1 BOTTLE in 1 CARTON (65162-039-03) / 30 TABLET, EXTENDED RELEASE in 1 BOTTLE 65162-039-06 1 BOTTLE in 1 CARTON (65162-039-06) / 60 TABLET, EXTENDED RELEASE in 1 BOTTLE 65162-039-17 2 BLISTER PACK in 1 CARTON (65162-039-17) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Ingredients (2)

dextromethorphan hydrobromide (60 mg/1) guaifenesin (1200 mg/1)

Linked Drug Pages (1)

Guaifenesin and Dextromethorphan HBr ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "bdfe8cad-61bb-48eb-a5c4-ec21abde055a", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "upc": ["0365162039030"], "unii": ["9D2RTI9KYH", "495W7451VQ"], "rxcui": ["1099074"], "spl_set_id": ["cfdbcdb0-531a-4d95-ac5d-64d6d034b252"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (65162-039-03)  / 30 TABLET, EXTENDED RELEASE in 1 BOTTLE", "package_ndc": "65162-039-03", "marketing_start_date": "20181101"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (65162-039-06)  / 60 TABLET, EXTENDED RELEASE in 1 BOTTLE", "package_ndc": "65162-039-06", "marketing_start_date": "20181101"}, {"sample": false, "description": "2 BLISTER PACK in 1 CARTON (65162-039-17)  / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "65162-039-17", "marketing_start_date": "20181101"}], "brand_name": "Guaifenesin and Dextromethorphan HBr", "product_id": "65162-039_bdfe8cad-61bb-48eb-a5c4-ec21abde055a", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_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 Antagonists [MoA]"], "product_ndc": "65162-039", "generic_name": "Guaifenesin and Dextromethorphan HBr", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Guaifenesin and Dextromethorphan HBr", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "60 mg/1"}, {"name": "GUAIFENESIN", "strength": "1200 mg/1"}], "application_number": "ANDA209692", "marketing_category": "ANDA", "marketing_start_date": "20181101", "listing_expiration_date": "20261231"}