guaifenesin

Generic: guaifenesin

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

Drug Facts

Product Profile

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

guaifenesin 600 mg/1

Manufacturer
GRANULES PHARMACEUTICALS INC.

Identifiers & Regulatory

Product NDC 70010-199
Product ID 70010-199_1cba14de-cac6-e5f3-e063-6294a90ab154
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA213420
Listing Expiration 2026-12-31
Marketing Start 2022-08-19

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 70010199
Hyphenated Format 70010-199

Supplemental Identifiers

RxCUI
636522
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
  • 600 mg/1
source: ndc
Packaging
  • 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (70010-199-05)
source: ndc

Packages (1)

70010-199-05 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (70010-199-05)

Ingredients (1)

guaifenesin (600 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": "1cba14de-cac6-e5f3-e063-6294a90ab154", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["495W7451VQ"], "rxcui": ["636522"], "spl_set_id": ["e6994e38-2a21-4bcf-e053-2995a90a0854"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["GRANULES PHARMACEUTICALS INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (70010-199-05)", "package_ndc": "70010-199-05", "marketing_start_date": "20220819"}], "brand_name": "GUAIFENESIN", "product_id": "70010-199_1cba14de-cac6-e5f3-e063-6294a90ab154", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Decreased Respiratory Secretion Viscosity [PE]", "Expectorant [EPC]", "Increased Respiratory Secretions [PE]"], "product_ndc": "70010-199", "generic_name": "GUAIFENESIN", "labeler_name": "GRANULES PHARMACEUTICALS INC.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "GUAIFENESIN", "active_ingredients": [{"name": "GUAIFENESIN", "strength": "600 mg/1"}], "application_number": "ANDA213420", "marketing_category": "ANDA", "marketing_start_date": "20220819", "listing_expiration_date": "20261231"}