guaifenesin

Generic: guaifenesin

Labeler: amneal pharmaceuticals llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name guaifenesin
Generic Name guaifenesin
Labeler amneal pharmaceuticals llc
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

guaifenesin 1200 mg/1

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 65162-037
Product ID 65162-037_f1b3934b-1fc2-4ce8-9465-e1f031daf9c5
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA207342
Listing Expiration 2026-12-31
Marketing Start 2018-07-27

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 65162037
Hyphenated Format 65162-037

Supplemental Identifiers

RxCUI
310621 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 ANDA207342 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1200 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (65162-037-03) / 30 TABLET, EXTENDED RELEASE in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (65162-037-06) / 60 TABLET, EXTENDED RELEASE in 1 BOTTLE
  • 2 BLISTER PACK in 1 CARTON (65162-037-28) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
source: ndc

Packages (3)

65162-037-03 1 BOTTLE in 1 CARTON (65162-037-03) / 30 TABLET, EXTENDED RELEASE in 1 BOTTLE 65162-037-06 1 BOTTLE in 1 CARTON (65162-037-06) / 60 TABLET, EXTENDED RELEASE in 1 BOTTLE 65162-037-28 2 BLISTER PACK in 1 CARTON (65162-037-28) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

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": "f1b3934b-1fc2-4ce8-9465-e1f031daf9c5", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["495W7451VQ"], "rxcui": ["310621", "636522"], "spl_set_id": ["ad67e6fd-a68f-44db-9718-84a2cef86e09"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (65162-037-03)  / 30 TABLET, EXTENDED RELEASE in 1 BOTTLE", "package_ndc": "65162-037-03", "marketing_start_date": "20180727"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (65162-037-06)  / 60 TABLET, EXTENDED RELEASE in 1 BOTTLE", "package_ndc": "65162-037-06", "marketing_start_date": "20180727"}, {"sample": false, "description": "2 BLISTER PACK in 1 CARTON (65162-037-28)  / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "65162-037-28", "marketing_start_date": "20180727"}], "brand_name": "Guaifenesin", "product_id": "65162-037_f1b3934b-1fc2-4ce8-9465-e1f031daf9c5", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Decreased Respiratory Secretion Viscosity [PE]", "Expectorant [EPC]", "Increased Respiratory Secretions [PE]"], "product_ndc": "65162-037", "generic_name": "Guaifenesin", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Guaifenesin", "active_ingredients": [{"name": "GUAIFENESIN", "strength": "1200 mg/1"}], "application_number": "ANDA207342", "marketing_category": "ANDA", "marketing_start_date": "20180727", "listing_expiration_date": "20261231"}