guaifenesin 400mg caplets

Generic: guaifenesin

Labeler: gendose pharmaceuticals, llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name guaifenesin 400mg caplets
Generic Name guaifenesin
Labeler gendose pharmaceuticals, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

guaifenesin 400 mg/1

Manufacturer
Gendose Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 77333-360
Product ID 77333-360_48032e44-d1b5-ea4d-e063-6394a90aba26
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2027-12-31
Marketing Start 2022-09-02

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 77333360
Hyphenated Format 77333-360

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 400mg caplets (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 BLISTER PACK in 1 BOX (77333-360-10) / 1 TABLET in 1 BLISTER PACK (77333-360-25)
source: ndc

Packages (1)

77333-360-10 100 BLISTER PACK in 1 BOX (77333-360-10) / 1 TABLET in 1 BLISTER PACK (77333-360-25)

Ingredients (1)

guaifenesin (400 mg/1)

Linked Drug Pages (1)

GUAIFENESIN 400MG CAPLETS ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "48032e44-d1b5-ea4d-e063-6394a90aba26", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["495W7451VQ"], "rxcui": ["359601"], "spl_set_id": ["e7b82ec7-ef23-50c1-e053-2a95a90a662f"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Gendose Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 BOX (77333-360-10)  / 1 TABLET in 1 BLISTER PACK (77333-360-25)", "package_ndc": "77333-360-10", "marketing_start_date": "20220902"}], "brand_name": "GUAIFENESIN 400MG CAPLETS", "product_id": "77333-360_48032e44-d1b5-ea4d-e063-6394a90aba26", "dosage_form": "TABLET", "pharm_class": ["Decreased Respiratory Secretion Viscosity [PE]", "Expectorant [EPC]", "Increased Respiratory Secretions [PE]"], "product_ndc": "77333-360", "generic_name": "GUAIFENESIN", "labeler_name": "Gendose Pharmaceuticals, LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "GUAIFENESIN 400MG CAPLETS", "active_ingredients": [{"name": "GUAIFENESIN", "strength": "400 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20220902", "listing_expiration_date": "20271231"}