guaifenesin extended release (68196-996)

Drug Facts

Product Profile

Brand Name guaifenesin extended release

Generic Name guaifenesin

Labeler sam's west inc

Dosage Form TABLET, EXTENDED RELEASE

Routes

ORAL

Active Ingredients

guaifenesin 1200 mg/1

Manufacturer

SAM'S WEST INC

Identifiers & Regulatory

Product NDC 68196-996

Product ID 68196-996_1cb900ed-18b4-4999-a149-0b4667abcda1

Product Type HUMAN OTC DRUG

Marketing Category ANDA

Application Number ANDA209254

Listing Expiration 2026-12-31

Marketing Start 2022-01-12

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 68196996

Hyphenated Format 68196-996

Supplemental Identifiers

RxCUI

310621

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 extended release (source: ndc)

Generic Name guaifenesin (source: ndc)

Application Number ANDA209254 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

1200 mg/1

source: ndc

Packaging

4 BLISTER PACK in 1 CARTON (68196-996-56) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

source: ndc

Packages (1)

68196-996-56 4 BLISTER PACK in 1 CARTON (68196-996-56) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Ingredients (1)

guaifenesin (1200 mg/1)

Linked Drug Pages (1)

Guaifenesin Extended Release ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "1cb900ed-18b4-4999-a149-0b4667abcda1", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["495W7451VQ"], "rxcui": ["310621"], "spl_set_id": ["64297bb8-cd4e-46d3-ae79-ea4aa4c03bca"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["SAM'S WEST INC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "4 BLISTER PACK in 1 CARTON (68196-996-56)  / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "68196-996-56", "marketing_start_date": "20220112"}], "brand_name": "Guaifenesin Extended Release", "product_id": "68196-996_1cb900ed-18b4-4999-a149-0b4667abcda1", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Decreased Respiratory Secretion Viscosity [PE]", "Expectorant [EPC]", "Increased Respiratory Secretions [PE]"], "product_ndc": "68196-996", "generic_name": "Guaifenesin", "labeler_name": "SAM'S WEST INC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Guaifenesin", "brand_name_suffix": "Extended Release", "active_ingredients": [{"name": "GUAIFENESIN", "strength": "1200 mg/1"}], "application_number": "ANDA209254", "marketing_category": "ANDA", "marketing_start_date": "20220112", "listing_expiration_date": "20261231"}