guaifenesin 1200 mg (25000-041)

Drug Facts

Product Profile

Brand Name guaifenesin 1200 mg

Generic Name guaifenesin 1200 mg

Labeler marksans pharma limited

Dosage Form TABLET

Routes

ORAL

Active Ingredients

guaifenesin 1200 mg/1

Manufacturer

MARKSANS PHARMA LIMITED

Identifiers & Regulatory

Product NDC 25000-041

Product ID 25000-041_0af3bdb4-c1f3-4941-a1de-6e08c49849cb

Product Type HUMAN OTC DRUG

Marketing Category ANDA

Application Number ANDA217780

Listing Expiration 2026-12-31

Marketing Start 2023-08-23

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 25000041

Hyphenated Format 25000-041

Supplemental Identifiers

RxCUI

310621 636522

UPC

0325000042127 0325000041120 0325000042554 0325000041342 0325000041755 0325000042011 0325000042998

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 1200 mg (source: ndc)

Generic Name guaifenesin 1200 mg (source: ndc)

Application Number ANDA217780 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

1200 mg/1

source: ndc

Packaging

500 TABLET in 1 BOTTLE (25000-041-12)
2 BLISTER PACK in 1 CARTON (25000-041-34) / 14 TABLET in 1 BLISTER PACK
2 BLISTER PACK in 1 CARTON (25000-041-75) / 6 TABLET in 1 BLISTER PACK

source: ndc

Packages (3)

25000-041-12 500 TABLET in 1 BOTTLE (25000-041-12) 25000-041-34 2 BLISTER PACK in 1 CARTON (25000-041-34) / 14 TABLET in 1 BLISTER PACK 25000-041-75 2 BLISTER PACK in 1 CARTON (25000-041-75) / 6 TABLET in 1 BLISTER PACK

Ingredients (1)

guaifenesin (1200 mg/1)

Linked Drug Pages (1)

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

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "0af3bdb4-c1f3-4941-a1de-6e08c49849cb", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "upc": ["0325000042127", "0325000041120", "0325000042554", "0325000041342", "0325000041755", "0325000042011", "0325000042998"], "unii": ["495W7451VQ"], "rxcui": ["310621", "636522"], "spl_set_id": ["fedf43d0-d6d1-4f50-bbab-396701e45cb2"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["MARKSANS PHARMA LIMITED"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET in 1 BOTTLE (25000-041-12)", "package_ndc": "25000-041-12", "marketing_start_date": "20230823"}, {"sample": false, "description": "2 BLISTER PACK in 1 CARTON (25000-041-34)  / 14 TABLET in 1 BLISTER PACK", "package_ndc": "25000-041-34", "marketing_start_date": "20250418"}, {"sample": false, "description": "2 BLISTER PACK in 1 CARTON (25000-041-75)  / 6 TABLET in 1 BLISTER PACK", "package_ndc": "25000-041-75", "marketing_start_date": "20230823"}], "brand_name": "Guaifenesin 1200 mg", "product_id": "25000-041_0af3bdb4-c1f3-4941-a1de-6e08c49849cb", "dosage_form": "TABLET", "pharm_class": ["Decreased Respiratory Secretion Viscosity [PE]", "Expectorant [EPC]", "Increased Respiratory Secretions [PE]"], "product_ndc": "25000-041", "generic_name": "Guaifenesin 1200 mg", "labeler_name": "MARKSANS PHARMA LIMITED", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Guaifenesin 1200 mg", "active_ingredients": [{"name": "GUAIFENESIN", "strength": "1200 mg/1"}], "application_number": "ANDA217780", "marketing_category": "ANDA", "marketing_start_date": "20230823", "listing_expiration_date": "20261231"}