simpex guaifenesin

Generic: guaifenesin

Labeler: simpex pharma pvt. ltd
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name simpex guaifenesin
Generic Name guaifenesin
Labeler simpex pharma pvt. ltd
Dosage Form TABLET
Routes
ORAL
Active Ingredients

guaifenesin 400 mg/1

Manufacturer
Simpex Pharma Pvt. Ltd

Identifiers & Regulatory

Product NDC 76457-004
Product ID 76457-004_0b586737-4616-db6e-e063-6294a90a6135
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2018-02-09

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 76457004
Hyphenated Format 76457-004

Supplemental Identifiers

RxCUI
359601
UPC
8901252955396
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 simpex guaifenesin (source: ndc)
Generic Name guaifenesin (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 CARTON (76457-004-00)
source: ndc

Packages (1)

76457-004-00 100 TABLET in 1 CARTON (76457-004-00)

Ingredients (1)

guaifenesin (400 mg/1)

Linked Drug Pages (1)

SIMPEX Guaifenesin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "0b586737-4616-db6e-e063-6294a90a6135", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "upc": ["8901252955396"], "unii": ["495W7451VQ"], "rxcui": ["359601"], "spl_set_id": ["1594f9d6-0c48-42bf-b76b-d621f215179a"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Simpex Pharma Pvt. Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 CARTON (76457-004-00)", "package_ndc": "76457-004-00", "marketing_start_date": "20180209"}], "brand_name": "SIMPEX Guaifenesin", "product_id": "76457-004_0b586737-4616-db6e-e063-6294a90a6135", "dosage_form": "TABLET", "pharm_class": ["Decreased Respiratory Secretion Viscosity [PE]", "Expectorant [EPC]", "Increased Respiratory Secretions [PE]"], "product_ndc": "76457-004", "generic_name": "GUAIFENESIN", "labeler_name": "Simpex Pharma Pvt. Ltd", "product_type": "HUMAN OTC DRUG", "brand_name_base": "SIMPEX Guaifenesin", "active_ingredients": [{"name": "GUAIFENESIN", "strength": "400 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20180209", "listing_expiration_date": "20261231"}