topcare mucus er (76162-123)

Drug Facts

Product Profile

Brand Name topcare mucus er

Generic Name guaifenesin

Labeler topco associates llc

Dosage Form TABLET, MULTILAYER, EXTENDED RELEASE

Routes

ORAL

Active Ingredients

guaifenesin 600 mg/1

Manufacturer

Topco Associates LLC

Identifiers & Regulatory

Product NDC 76162-123

Product ID 76162-123_e0a05c1e-af6d-4d2d-9d0e-80f1821f5266

Product Type HUMAN OTC DRUG

Marketing Category ANDA

Application Number ANDA078912

Listing Expiration 2026-12-31

Marketing Start 2022-09-29

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 76162123

Hyphenated Format 76162-123

Supplemental Identifiers

RxCUI

636522

UNII

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 topcare mucus er (source: ndc)

Generic Name guaifenesin (source: ndc)

Application Number ANDA078912 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

600 mg/1

source: ndc

Packaging

1 BOTTLE in 1 CARTON (76162-123-58) / 40 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE
1 BOTTLE in 1 CARTON (76162-123-60) / 20 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE

source: ndc

Packages (2)

76162-123-58 1 BOTTLE in 1 CARTON (76162-123-58) / 40 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE 76162-123-60 1 BOTTLE in 1 CARTON (76162-123-60) / 20 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE

Ingredients (1)

guaifenesin (600 mg/1)

Linked Drug Pages (1)

Topcare mucus er ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "e0a05c1e-af6d-4d2d-9d0e-80f1821f5266", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["495W7451VQ"], "rxcui": ["636522"], "spl_set_id": ["e3c900ad-21b1-4cd0-8c48-f54f115df403"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Topco Associates LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (76162-123-58)  / 40 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE", "package_ndc": "76162-123-58", "marketing_start_date": "20220929"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (76162-123-60)  / 20 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE", "package_ndc": "76162-123-60", "marketing_start_date": "20241104"}], "brand_name": "Topcare mucus er", "product_id": "76162-123_e0a05c1e-af6d-4d2d-9d0e-80f1821f5266", "dosage_form": "TABLET, MULTILAYER, EXTENDED RELEASE", "pharm_class": ["Decreased Respiratory Secretion Viscosity [PE]", "Expectorant [EPC]", "Increased Respiratory Secretions [PE]"], "product_ndc": "76162-123", "generic_name": "guaifenesin", "labeler_name": "Topco Associates LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Topcare mucus er", "active_ingredients": [{"name": "GUAIFENESIN", "strength": "600 mg/1"}], "application_number": "ANDA078912", "marketing_category": "ANDA", "marketing_start_date": "20220929", "listing_expiration_date": "20261231"}