guaifenesin and pseudoephedrine hydrochloride (41415-994)

Drug Facts

Product Profile

Brand Name guaifenesin and pseudoephedrine hydrochloride

Generic Name guaifenesin and pseudoephedrine hydrochloride

Labeler publix super markets, inc

Dosage Form TABLET, EXTENDED RELEASE

Routes

ORAL

Active Ingredients

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

Manufacturer

PUBLIX SUPER MARKETS, INC

Identifiers & Regulatory

Product NDC 41415-994

Product ID 41415-994_a36d0524-b1d7-4daf-a62e-54f63168b0cd

Product Type HUMAN OTC DRUG

Marketing Category ANDA

Application Number ANDA212542

Listing Expiration 2026-12-31

Marketing Start 2022-04-07

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 41415994

Hyphenated Format 41415-994

Supplemental Identifiers

RxCUI

1305603

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 hydrochloride (source: ndc)

Generic Name guaifenesin and pseudoephedrine hydrochloride (source: ndc)

Application Number ANDA212542 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

600 mg/1
60 mg/1

source: ndc

Packaging

1 BLISTER PACK in 1 CARTON (41415-994-18) / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
2 BLISTER PACK in 1 CARTON (41415-994-36) / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

source: ndc

Packages (2)

41415-994-18 1 BLISTER PACK in 1 CARTON (41415-994-18) / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK 41415-994-36 2 BLISTER PACK in 1 CARTON (41415-994-36) / 18 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 Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "a36d0524-b1d7-4daf-a62e-54f63168b0cd", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["495W7451VQ", "6V9V2RYJ8N"], "rxcui": ["1305603"], "spl_set_id": ["c857bcd9-6696-40d5-93c0-65097598cd4b"], "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 (41415-994-18)  / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "41415-994-18", "marketing_start_date": "20220407"}, {"sample": false, "description": "2 BLISTER PACK in 1 CARTON (41415-994-36)  / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "41415-994-36", "marketing_start_date": "20220407"}], "brand_name": "Guaifenesin and Pseudoephedrine Hydrochloride", "product_id": "41415-994_a36d0524-b1d7-4daf-a62e-54f63168b0cd", "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": "41415-994", "generic_name": "Guaifenesin and Pseudoephedrine Hydrochloride", "labeler_name": "PUBLIX SUPER MARKETS, INC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Guaifenesin and Pseudoephedrine Hydrochloride", "active_ingredients": [{"name": "GUAIFENESIN", "strength": "600 mg/1"}, {"name": "PSEUDOEPHEDRINE HYDROCHLORIDE", "strength": "60 mg/1"}], "application_number": "ANDA212542", "marketing_category": "ANDA", "marketing_start_date": "20220407", "listing_expiration_date": "20261231"}