guaifenesin extended release (41415-997)

Drug Facts

Product Profile

Brand Name guaifenesin extended release

Generic Name guaifenesin

Labeler publix super markets, inc

Dosage Form TABLET, EXTENDED RELEASE

Routes

ORAL

Active Ingredients

guaifenesin 1200 mg/1

Manufacturer

PUBLIX SUPER MARKETS, INC

Identifiers & Regulatory

Product NDC 41415-997

Product ID 41415-997_358eee0d-f68a-daf8-e063-6394a90a4d07

Product Type HUMAN OTC DRUG

Marketing Category ANDA

Application Number ANDA209254

Listing Expiration 2026-12-31

Marketing Start 2017-12-10

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 41415997

Hyphenated Format 41415-997

Supplemental Identifiers

RxCUI

310621

UPC

0041415527737

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 guaifenesin extended release (source: ndc)

Generic Name guaifenesin (source: ndc)

Application Number ANDA209254 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

1200 mg/1

source: ndc

Packaging

1 BLISTER PACK in 1 CARTON (41415-997-14) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

source: ndc

Packages (1)

41415-997-14 1 BLISTER PACK in 1 CARTON (41415-997-14) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Ingredients (1)

guaifenesin (1200 mg/1)

Linked Drug Pages (1)

Guaifenesin Extended Release ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "358eee0d-f68a-daf8-e063-6394a90a4d07", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "upc": ["0041415527737"], "unii": ["495W7451VQ"], "rxcui": ["310621"], "spl_set_id": ["038e1801-b978-4a2e-ae8c-8803596ec09c"], "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 (41415-997-14)  / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "41415-997-14", "marketing_start_date": "20171210"}], "brand_name": "Guaifenesin Extended Release", "product_id": "41415-997_358eee0d-f68a-daf8-e063-6394a90a4d07", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Decreased Respiratory Secretion Viscosity [PE]", "Expectorant [EPC]", "Increased Respiratory Secretions [PE]"], "product_ndc": "41415-997", "generic_name": "Guaifenesin", "labeler_name": "PUBLIX SUPER MARKETS, INC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Guaifenesin", "brand_name_suffix": "Extended Release", "active_ingredients": [{"name": "GUAIFENESIN", "strength": "1200 mg/1"}], "application_number": "ANDA209254", "marketing_category": "ANDA", "marketing_start_date": "20171210", "listing_expiration_date": "20261231"}