guaifenesin and pseudoephedrine hcl (62207-827)

Drug Facts

Product Profile

Brand Name guaifenesin and pseudoephedrine hcl

Generic Name guaifenesin and pseudoephedrine hcl

Labeler granules india ltd

Dosage Form TABLET, EXTENDED RELEASE

Routes

ORAL

Active Ingredients

guaifenesin 600 mg/1, pseudoephedrine hydrochloride 60 mg/1

Manufacturer

Granules India Ltd

Identifiers & Regulatory

Product NDC 62207-827

Product ID 62207-827_44f2a33c-21a2-28a8-e063-6294a90a50ab

Product Type HUMAN OTC DRUG

Marketing Category ANDA

Application Number ANDA216082

Listing Expiration 2026-12-31

Marketing Start 2023-06-01

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 62207827

Hyphenated Format 62207-827

Supplemental Identifiers

RxCUI

1244675 1305603

UPC

0362207828710 0362207827720

UNII

6V9V2RYJ8N 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 pseudoephedrine hcl (source: ndc)

Generic Name guaifenesin and pseudoephedrine hcl (source: ndc)

Application Number ANDA216082 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

600 mg/1
60 mg/1

source: ndc

Packaging

9 BLISTER PACK in 1 CARTON (62207-827-72) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

source: ndc

Packages (1)

62207-827-72 9 BLISTER PACK in 1 CARTON (62207-827-72) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Ingredients (2)

guaifenesin (600 mg/1) pseudoephedrine hydrochloride (60 mg/1)

Linked Drug Pages (1)

Guaifenesin and Pseudoephedrine HCl ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "44f2a33c-21a2-28a8-e063-6294a90a50ab", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "upc": ["0362207828710", "0362207827720"], "unii": ["6V9V2RYJ8N", "495W7451VQ"], "rxcui": ["1244675", "1305603"], "spl_set_id": ["75f4ff44-02e7-4a23-a394-85fe8b442e1a"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Granules India Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "9 BLISTER PACK in 1 CARTON (62207-827-72)  / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "62207-827-72", "marketing_start_date": "20230601"}], "brand_name": "Guaifenesin and Pseudoephedrine HCl", "product_id": "62207-827_44f2a33c-21a2-28a8-e063-6294a90a50ab", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Adrenergic alpha-Agonists [MoA]", "Decreased Respiratory Secretion Viscosity [PE]", "Expectorant [EPC]", "Increased Respiratory Secretions [PE]", "alpha-Adrenergic Agonist [EPC]"], "product_ndc": "62207-827", "generic_name": "Guaifenesin and Pseudoephedrine HCl", "labeler_name": "Granules India Ltd", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Guaifenesin and Pseudoephedrine HCl", "active_ingredients": [{"name": "GUAIFENESIN", "strength": "600 mg/1"}, {"name": "PSEUDOEPHEDRINE HYDROCHLORIDE", "strength": "60 mg/1"}], "application_number": "ANDA216082", "marketing_category": "ANDA", "marketing_start_date": "20230601", "listing_expiration_date": "20261231"}