guaifenesin and dextromethorphan hbr

Generic: guaifenesin and dextromethorphan hbr

Labeler: amneal pharmaceuticals llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

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 30 mg/1, guaifenesin 600 mg/1

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 65162-038
Product ID 65162-038_5d3150b8-1c7d-4789-a6cc-4f1bd0a5bbea
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 65162038
Hyphenated Format 65162-038

Supplemental Identifiers

RxCUI
1298324
UPC
0365162038170
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
  • 30 mg/1
  • 600 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (65162-038-03) / 30 TABLET, EXTENDED RELEASE in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (65162-038-06) / 60 TABLET, EXTENDED RELEASE in 1 BOTTLE
  • 2 BLISTER PACK in 1 CARTON (65162-038-17) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
source: ndc

Packages (3)

65162-038-03 1 BOTTLE in 1 CARTON (65162-038-03) / 30 TABLET, EXTENDED RELEASE in 1 BOTTLE 65162-038-06 1 BOTTLE in 1 CARTON (65162-038-06) / 60 TABLET, EXTENDED RELEASE in 1 BOTTLE 65162-038-17 2 BLISTER PACK in 1 CARTON (65162-038-17) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Ingredients (2)

dextromethorphan hydrobromide (30 mg/1) guaifenesin (600 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": "5d3150b8-1c7d-4789-a6cc-4f1bd0a5bbea", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "upc": ["0365162038170"], "unii": ["9D2RTI9KYH", "495W7451VQ"], "rxcui": ["1298324"], "spl_set_id": ["5760a828-1c28-4272-a7b7-ac98466aa294"], "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 (65162-038-03)  / 30 TABLET, EXTENDED RELEASE in 1 BOTTLE", "package_ndc": "65162-038-03", "marketing_start_date": "20181101"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (65162-038-06)  / 60 TABLET, EXTENDED RELEASE in 1 BOTTLE", "package_ndc": "65162-038-06", "marketing_start_date": "20181101"}, {"sample": false, "description": "2 BLISTER PACK in 1 CARTON (65162-038-17)  / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "65162-038-17", "marketing_start_date": "20181101"}], "brand_name": "Guaifenesin and Dextromethorphan HBr", "product_id": "65162-038_5d3150b8-1c7d-4789-a6cc-4f1bd0a5bbea", "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": "65162-038", "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": "30 mg/1"}, {"name": "GUAIFENESIN", "strength": "600 mg/1"}], "application_number": "ANDA209692", "marketing_category": "ANDA", "marketing_start_date": "20181101", "listing_expiration_date": "20261231"}