topcare mucus er (76162-409)

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 1200 mg/1

Manufacturer

Topco Associates LLC

Identifiers & Regulatory

Product NDC 76162-409

Product ID 76162-409_d46da7e9-49e2-4d0b-8a68-6eed1e0bf145

Product Type HUMAN OTC DRUG

Marketing Category ANDA

Application Number ANDA078912

Listing Expiration 2026-12-31

Marketing Start 2025-03-26

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 76162409

Hyphenated Format 76162-409

Supplemental Identifiers

RxCUI

310621

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

1200 mg/1

source: ndc

Packaging

4 BLISTER PACK in 1 CARTON (76162-409-01) / 7 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BLISTER PACK
2 BLISTER PACK in 1 CARTON (76162-409-74) / 7 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BLISTER PACK

source: ndc

Packages (2)

76162-409-01 4 BLISTER PACK in 1 CARTON (76162-409-01) / 7 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BLISTER PACK 76162-409-74 2 BLISTER PACK in 1 CARTON (76162-409-74) / 7 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BLISTER PACK

Ingredients (1)

guaifenesin (1200 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": "d46da7e9-49e2-4d0b-8a68-6eed1e0bf145", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["495W7451VQ"], "rxcui": ["310621"], "spl_set_id": ["b787eac7-8f87-49a2-899b-5f524eb7b1fc"], "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": "4 BLISTER PACK in 1 CARTON (76162-409-01)  / 7 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "76162-409-01", "marketing_start_date": "20250409"}, {"sample": false, "description": "2 BLISTER PACK in 1 CARTON (76162-409-74)  / 7 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "76162-409-74", "marketing_start_date": "20250326"}], "brand_name": "Topcare Mucus ER", "product_id": "76162-409_d46da7e9-49e2-4d0b-8a68-6eed1e0bf145", "dosage_form": "TABLET, MULTILAYER, EXTENDED RELEASE", "pharm_class": ["Decreased Respiratory Secretion Viscosity [PE]", "Expectorant [EPC]", "Increased Respiratory Secretions [PE]"], "product_ndc": "76162-409", "generic_name": "guaifenesin", "labeler_name": "Topco Associates LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Topcare Mucus ER", "active_ingredients": [{"name": "GUAIFENESIN", "strength": "1200 mg/1"}], "application_number": "ANDA078912", "marketing_category": "ANDA", "marketing_start_date": "20250326", "listing_expiration_date": "20261231"}