guaifenesin 400

Generic: guaifenesin tablets 400

Labeler: invatech pharma solutions llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name guaifenesin 400
Generic Name guaifenesin tablets 400
Labeler invatech pharma solutions llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

guaifenesin 400 mg/1

Manufacturer
InvaTech Pharma Solutions LLC

Identifiers & Regulatory

Product NDC 57631-012
Product ID 57631-012_4029150e-7782-a118-e063-6294a90a09c1
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2021-01-13

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 57631012
Hyphenated Format 57631-012

Supplemental Identifiers

RxCUI
359601
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 400 (source: ndc)
Generic Name guaifenesin tablets 400 (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
source: ndc
Packaging
  • 28000 TABLET in 1 BOX (57631-012-00)
source: ndc

Packages (1)

57631-012-00 28000 TABLET in 1 BOX (57631-012-00)

Ingredients (1)

guaifenesin (400 mg/1)

Linked Drug Pages (1)

Guaifenesin 400 ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4029150e-7782-a118-e063-6294a90a09c1", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["495W7451VQ"], "rxcui": ["359601"], "spl_set_id": ["40291505-55ca-0759-e063-6394a90acee1"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["InvaTech Pharma Solutions LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "28000 TABLET in 1 BOX (57631-012-00)", "package_ndc": "57631-012-00", "marketing_start_date": "20210113"}], "brand_name": "Guaifenesin 400", "product_id": "57631-012_4029150e-7782-a118-e063-6294a90a09c1", "dosage_form": "TABLET", "pharm_class": ["Decreased Respiratory Secretion Viscosity [PE]", "Expectorant [EPC]", "Increased Respiratory Secretions [PE]"], "product_ndc": "57631-012", "generic_name": "Guaifenesin Tablets 400", "labeler_name": "InvaTech Pharma Solutions LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Guaifenesin 400", "active_ingredients": [{"name": "GUAIFENESIN", "strength": "400 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20210113", "listing_expiration_date": "20261231"}