guaifenesin and dextromethorphan hbr (41415-998)

Drug Facts

Product Profile

Brand Name guaifenesin and dextromethorphan hbr

Generic Name guaifenesin and dextromethorphan hbr

Labeler publix super markets, inc

Dosage Form TABLET, EXTENDED RELEASE

Routes

ORAL

Active Ingredients

dextromethorphan hydrobromide 30 mg/1, guaifenesin 600 mg/1

Manufacturer

PUBLIX SUPER MARKETS, INC

Identifiers & Regulatory

Product NDC 41415-998

Product ID 41415-998_2dc6bbee-c2f4-2731-e063-6394a90ad514

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 41415998

Hyphenated Format 41415-998

Supplemental Identifiers

RxCUI

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

30 mg/1
600 mg/1

source: ndc

Packaging

1 BLISTER PACK in 1 CARTON (41415-998-20) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

source: ndc

Packages (1)

41415-998-20 1 BLISTER PACK in 1 CARTON (41415-998-20) / 20 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": "2dc6bbee-c2f4-2731-e063-6394a90ad514", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["9D2RTI9KYH", "495W7451VQ"], "rxcui": ["1298324"], "spl_set_id": ["74fa022a-bad9-4d0f-8dda-5624fae3867b"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["PUBLIX SUPER MARKETS, INC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (41415-998-20)  / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "41415-998-20", "marketing_start_date": "20210701"}], "brand_name": "Guaifenesin and Dextromethorphan HBr", "product_id": "41415-998_2dc6bbee-c2f4-2731-e063-6394a90ad514", "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": "41415-998", "generic_name": "Guaifenesin and Dextromethorphan Hbr", "labeler_name": "PUBLIX SUPER MARKETS, INC", "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": "ANDA214781", "marketing_category": "ANDA", "marketing_start_date": "20210701", "listing_expiration_date": "20261231"}