guaifenesin 600 mg (51316-008)

Drug Facts

Product Profile

Brand Name guaifenesin 600 mg

Generic Name guaifenesin

Labeler cvs pharmacy

Dosage Form TABLET, EXTENDED RELEASE

Routes

ORAL

Active Ingredients

guaifenesin 600 mg/1

Manufacturer

CVS Pharmacy

Identifiers & Regulatory

Product NDC 51316-008

Product ID 51316-008_0f020bff-5cb6-4169-5caa-fceeb1f30813

Product Type HUMAN OTC DRUG

Marketing Category ANDA

Application Number ANDA215932

Listing Expiration 2026-12-31

Marketing Start 2022-09-01

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 51316008

Hyphenated Format 51316-008

Supplemental Identifiers

RxCUI

636522

UNII

495W7451VQ

NUI

N0000193956 N0000008867 N0000009560

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 600 mg (source: ndc)

Generic Name guaifenesin (source: ndc)

Application Number ANDA215932 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

600 mg/1

source: ndc

Packaging

5 BLISTER PACK in 1 CARTON (51316-008-01) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

source: ndc

Packages (1)

51316-008-01 5 BLISTER PACK in 1 CARTON (51316-008-01) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Ingredients (1)

guaifenesin (600 mg/1)

Linked Drug Pages (1)

Guaifenesin 600 mg ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "0f020bff-5cb6-4169-5caa-fceeb1f30813", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["495W7451VQ"], "rxcui": ["636522"], "spl_set_id": ["ed242994-facd-750e-b7e1-2eec42c1f65f"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["CVS Pharmacy"]}, "finished": true, "packaging": [{"sample": false, "description": "5 BLISTER PACK in 1 CARTON (51316-008-01)  / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "51316-008-01", "marketing_start_date": "20230501"}], "brand_name": "Guaifenesin 600 mg", "product_id": "51316-008_0f020bff-5cb6-4169-5caa-fceeb1f30813", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Decreased Respiratory Secretion Viscosity [PE]", "Expectorant [EPC]", "Increased Respiratory Secretions [PE]"], "product_ndc": "51316-008", "generic_name": "Guaifenesin", "labeler_name": "CVS Pharmacy", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Guaifenesin 600 mg", "active_ingredients": [{"name": "GUAIFENESIN", "strength": "600 mg/1"}], "application_number": "ANDA215932", "marketing_category": "ANDA", "marketing_start_date": "20220901", "listing_expiration_date": "20261231"}