guaifenesin and pseudoephedrine hcl (58602-834)

Drug Facts

Product Profile

Brand Name guaifenesin and pseudoephedrine hcl

Generic Name guaifenesin and pseudoephedrine hcl

Labeler aurohealth llc

Dosage Form TABLET, EXTENDED RELEASE

Routes

ORAL

Active Ingredients

guaifenesin 1200 mg/1, pseudoephedrine hydrochloride 120 mg/1

Manufacturer

Aurohealth LLC

Identifiers & Regulatory

Product NDC 58602-834

Product ID 58602-834_2fb64af9-47fb-442a-b7ee-8aae3d5b0ddb

Product Type HUMAN OTC DRUG

Marketing Category ANDA

Application Number ANDA213203

Listing Expiration 2026-12-31

Marketing Start 2020-03-25

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 58602834

Hyphenated Format 58602-834

Supplemental Identifiers

RxCUI

1244675

UNII

495W7451VQ 6V9V2RYJ8N

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 ANDA213203 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

1200 mg/1
120 mg/1

source: ndc

Packaging

1 BLISTER PACK in 1 CARTON (58602-834-77) / 12 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
2 BLISTER PACK in 1 CARTON (58602-834-78) / 12 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

source: ndc

Packages (2)

58602-834-77 1 BLISTER PACK in 1 CARTON (58602-834-77) / 12 TABLET, EXTENDED RELEASE in 1 BLISTER PACK 58602-834-78 2 BLISTER PACK in 1 CARTON (58602-834-78) / 12 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Ingredients (2)

guaifenesin (1200 mg/1) pseudoephedrine hydrochloride (120 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": "2fb64af9-47fb-442a-b7ee-8aae3d5b0ddb", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["495W7451VQ", "6V9V2RYJ8N"], "rxcui": ["1244675"], "spl_set_id": ["2f622f57-4de0-44a9-a21f-c98260574f1e"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Aurohealth LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (58602-834-77)  / 12 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "58602-834-77", "marketing_start_date": "20200325"}, {"sample": false, "description": "2 BLISTER PACK in 1 CARTON (58602-834-78)  / 12 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "58602-834-78", "marketing_start_date": "20200325"}], "brand_name": "Guaifenesin and Pseudoephedrine HCl", "product_id": "58602-834_2fb64af9-47fb-442a-b7ee-8aae3d5b0ddb", "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": "58602-834", "generic_name": "Guaifenesin and Pseudoephedrine HCl", "labeler_name": "Aurohealth LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Guaifenesin and Pseudoephedrine HCl", "active_ingredients": [{"name": "GUAIFENESIN", "strength": "1200 mg/1"}, {"name": "PSEUDOEPHEDRINE HYDROCHLORIDE", "strength": "120 mg/1"}], "application_number": "ANDA213203", "marketing_category": "ANDA", "marketing_start_date": "20200325", "listing_expiration_date": "20261231"}