guaifenesin 600 mg (70677-1257)

Drug Facts

Product Profile

Brand Name guaifenesin 600 mg

Generic Name guaifenesin

Labeler strategic sourcing services, llc

Dosage Form TABLET, EXTENDED RELEASE

Routes

ORAL

Active Ingredients

guaifenesin 600 mg/1

Manufacturer

Strategic Sourcing Services, LLC

Identifiers & Regulatory

Product NDC 70677-1257

Product ID 70677-1257_ef056a34-8314-eb42-2978-51ded05b0082

Product Type HUMAN OTC DRUG

Marketing Category ANDA

Application Number ANDA215932

Listing Expiration 2026-12-31

Marketing Start 2022-03-15

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 706771257

Hyphenated Format 70677-1257

Supplemental Identifiers

RxCUI

310621 636522

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 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

1 BLISTER PACK in 1 CARTON (70677-1257-1) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
2 BLISTER PACK in 1 CARTON (70677-1257-2) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

source: ndc

Packages (2)

70677-1257-1 1 BLISTER PACK in 1 CARTON (70677-1257-1) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK 70677-1257-2 2 BLISTER PACK in 1 CARTON (70677-1257-2) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Ingredients (1)

guaifenesin (600 mg/1)

Linked Drug Pages (1)

Guaifenesin 600 mg, Guaifenesin 1200 mg ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "ef056a34-8314-eb42-2978-51ded05b0082", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["495W7451VQ"], "rxcui": ["310621", "636522"], "spl_set_id": ["469c5f00-1b6c-6fc7-a352-65764ff25d45"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Strategic Sourcing Services, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (70677-1257-1)  / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "70677-1257-1", "marketing_start_date": "20250215"}, {"sample": false, "description": "2 BLISTER PACK in 1 CARTON (70677-1257-2)  / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "70677-1257-2", "marketing_start_date": "20250215"}], "brand_name": "Guaifenesin 600 mg", "product_id": "70677-1257_ef056a34-8314-eb42-2978-51ded05b0082", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Decreased Respiratory Secretion Viscosity [PE]", "Expectorant [EPC]", "Increased Respiratory Secretions [PE]"], "product_ndc": "70677-1257", "generic_name": "Guaifenesin", "labeler_name": "Strategic Sourcing Services, LLC", "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": "20220315", "listing_expiration_date": "20261231"}