mucus relief extended release (0536-1163)

Drug Facts

Product Profile

Brand Name mucus relief extended release

Generic Name guaifenesin

Labeler rugby laboratories, inc.

Dosage Form TABLET, EXTENDED RELEASE

Routes

ORAL

Active Ingredients

guaifenesin 600 mg/1

Manufacturer

Rugby Laboratories, Inc.

Identifiers & Regulatory

Product NDC 0536-1163

Product ID 0536-1163_ed6550fd-e566-47aa-9de7-f3245592b45c

Product Type HUMAN OTC DRUG

Marketing Category ANDA

Application Number ANDA207342

Listing Expiration 2026-12-31

Marketing Start 2018-08-31

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 05361163

Hyphenated Format 0536-1163

Supplemental Identifiers

RxCUI

636522

UPC

0305361163617

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 mucus relief extended release (source: ndc)

Generic Name guaifenesin (source: ndc)

Application Number ANDA207342 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

600 mg/1

source: ndc

Packaging

100 BLISTER PACK in 1 CARTON (0536-1163-61) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

source: ndc

Packages (1)

0536-1163-61 100 BLISTER PACK in 1 CARTON (0536-1163-61) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Ingredients (1)

guaifenesin (600 mg/1)

Linked Drug Pages (1)

Mucus Relief Extended Release ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "ed6550fd-e566-47aa-9de7-f3245592b45c", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "upc": ["0305361163617"], "unii": ["495W7451VQ"], "rxcui": ["636522"], "spl_set_id": ["8bc6f08e-a941-4fa8-8dd6-a699abf2337d"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Rugby Laboratories, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 CARTON (0536-1163-61)  / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "0536-1163-61", "marketing_start_date": "20180831"}], "brand_name": "Mucus Relief Extended Release", "product_id": "0536-1163_ed6550fd-e566-47aa-9de7-f3245592b45c", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Decreased Respiratory Secretion Viscosity [PE]", "Expectorant [EPC]", "Increased Respiratory Secretions [PE]"], "product_ndc": "0536-1163", "generic_name": "Guaifenesin", "labeler_name": "Rugby Laboratories, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Mucus Relief Extended Release", "active_ingredients": [{"name": "GUAIFENESIN", "strength": "600 mg/1"}], "application_number": "ANDA207342", "marketing_category": "ANDA", "marketing_start_date": "20180831", "listing_expiration_date": "20261231"}