guaifenesin

Generic: guaifenesin

Labeler: granules usa, inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name guaifenesin
Generic Name guaifenesin
Labeler granules usa, inc.
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

guaifenesin 1200 mg/1

Manufacturer
GRANULES USA, INC.

Identifiers & Regulatory

Product NDC 69848-018
Product ID 69848-018_469099a1-3de3-d107-e063-6294a90adf16
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA213420
Listing Expiration 2026-12-31
Marketing Start 2024-09-12

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 69848018
Hyphenated Format 69848-018

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 (source: ndc)
Generic Name guaifenesin (source: ndc)
Application Number ANDA213420 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1200 mg/1
source: ndc
Packaging
  • 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (69848-018-16)
source: ndc

Packages (1)

69848-018-16 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (69848-018-16)

Ingredients (1)

guaifenesin (1200 mg/1)

Linked Drug Pages (1)

Guaifenesin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "469099a1-3de3-d107-e063-6294a90adf16", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["495W7451VQ"], "rxcui": ["310621"], "spl_set_id": ["a62e2045-8ec2-1771-e053-2995a90a03b4"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["GRANULES USA, INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (69848-018-16)", "package_ndc": "69848-018-16", "marketing_start_date": "20240912"}], "brand_name": "Guaifenesin", "product_id": "69848-018_469099a1-3de3-d107-e063-6294a90adf16", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Decreased Respiratory Secretion Viscosity [PE]", "Expectorant [EPC]", "Increased Respiratory Secretions [PE]"], "product_ndc": "69848-018", "generic_name": "Guaifenesin", "labeler_name": "GRANULES USA, INC.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Guaifenesin", "active_ingredients": [{"name": "GUAIFENESIN", "strength": "1200 mg/1"}], "application_number": "ANDA213420", "marketing_category": "ANDA", "marketing_start_date": "20240912", "listing_expiration_date": "20261231"}