guaifenesin and pseudoephedrine hydrochloride (0363-0077)

Drug Facts

Product Profile

Brand Name guaifenesin and pseudoephedrine hydrochloride

Generic Name guaifenesin and pseudoephedrine hydrochloride

Labeler walgreen company

Dosage Form TABLET, EXTENDED RELEASE

Routes

ORAL

Active Ingredients

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

Manufacturer

WALGREEN COMPANY

Identifiers & Regulatory

Product NDC 0363-0077

Product ID 0363-0077_23bd928b-a15a-4da4-80c3-c599113f8376

Product Type HUMAN OTC DRUG

Marketing Category NDA

Application Number NDA021585

Listing Expiration 2026-12-31

Marketing Start 2017-08-01

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 03630077

Hyphenated Format 0363-0077

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 NDA021585 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

600 mg/1
60 mg/1

source: ndc

Packaging

1 BLISTER PACK in 1 CARTON (0363-0077-18) / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
2 BLISTER PACK in 1 CARTON (0363-0077-36) / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

source: ndc

Packages (2)

0363-0077-18 1 BLISTER PACK in 1 CARTON (0363-0077-18) / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK 0363-0077-36 2 BLISTER PACK in 1 CARTON (0363-0077-36) / 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": "23bd928b-a15a-4da4-80c3-c599113f8376", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["495W7451VQ", "6V9V2RYJ8N"], "rxcui": ["1305603"], "spl_set_id": ["310d14be-e7ea-44b8-8b04-cffa39440d50"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["WALGREEN COMPANY"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (0363-0077-18)  / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "0363-0077-18", "marketing_start_date": "20170801"}, {"sample": false, "description": "2 BLISTER PACK in 1 CARTON (0363-0077-36)  / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "0363-0077-36", "marketing_start_date": "20170801"}], "brand_name": "Guaifenesin and Pseudoephedrine Hydrochloride", "product_id": "0363-0077_23bd928b-a15a-4da4-80c3-c599113f8376", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Adrenergic alpha-Agonists [MoA]", "alpha-Adrenergic Agonist [EPC]"], "product_ndc": "0363-0077", "generic_name": "Guaifenesin and Pseudoephedrine Hydrochloride", "labeler_name": "WALGREEN COMPANY", "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": "NDA021585", "marketing_category": "NDA", "marketing_start_date": "20170801", "listing_expiration_date": "20261231"}