guaifenesin and dextromethorphan hbr (63304-110)

Drug Facts

Product Profile

Brand Name guaifenesin and dextromethorphan hbr

Generic Name guaifenesin and dextromethorphan hbr

Labeler sun pharmaceutical industries, inc.

Dosage Form TABLET, EXTENDED RELEASE

Routes

ORAL

Active Ingredients

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

Manufacturer

SUN PHARMACEUTICAL INDUSTRIES, INC.

Identifiers & Regulatory

Product NDC 63304-110

Product ID 63304-110_801949ca-1baf-4a19-8466-91b4269a2c63

Product Type HUMAN OTC DRUG

Marketing Category ANDA

Application Number ANDA214781

Listing Expiration 2026-12-31

Marketing Start 2021-07-01

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 63304110

Hyphenated Format 63304-110

Supplemental Identifiers

RxCUI

1099074 1298324

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 ANDA214781 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

60 mg/1
1200 mg/1

source: ndc

Packaging

1 BLISTER PACK in 1 CARTON (63304-110-54) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

source: ndc

Packages (1)

63304-110-54 1 BLISTER PACK in 1 CARTON (63304-110-54) / 14 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": "801949ca-1baf-4a19-8466-91b4269a2c63", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["9D2RTI9KYH", "495W7451VQ"], "rxcui": ["1099074", "1298324"], "spl_set_id": ["06328741-03e3-49cf-ae44-d4c2116e38a3"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["SUN PHARMACEUTICAL INDUSTRIES, INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (63304-110-54)  / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "63304-110-54", "marketing_start_date": "20210701"}], "brand_name": "Guaifenesin and Dextromethorphan HBr", "product_id": "63304-110_801949ca-1baf-4a19-8466-91b4269a2c63", "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": "63304-110", "generic_name": "Guaifenesin and Dextromethorphan HBr", "labeler_name": "SUN PHARMACEUTICAL INDUSTRIES, INC.", "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": "ANDA214781", "marketing_category": "ANDA", "marketing_start_date": "20210701", "listing_expiration_date": "20261231"}