guanfacine hydrochloride

Generic: guanfacine

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

Drug Facts

Product Profile

Brand Name guanfacine hydrochloride
Generic Name guanfacine
Labeler amneal pharmaceuticals llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

guanfacine hydrochloride 1 mg/1

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 65162-711
Product ID 65162-711_2742ab0e-0dcc-4be7-8356-ea7ba8dfe6a7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075109
Listing Expiration 2026-12-31
Marketing Start 1998-11-25

Pharmacologic Class

Classes
adrenergic alpha2-agonists [moa] central alpha-2 adrenergic agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65162711
Hyphenated Format 65162-711

Supplemental Identifiers

RxCUI
197745 197746
UPC
0365162713039 0365162711035
UNII
PML56A160O

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 guanfacine hydrochloride (source: ndc)
Generic Name guanfacine (source: ndc)
Application Number ANDA075109 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (65162-711-03)
  • 100 TABLET in 1 BOTTLE (65162-711-10)
source: ndc

Packages (2)

65162-711-03 30 TABLET in 1 BOTTLE (65162-711-03) 65162-711-10 100 TABLET in 1 BOTTLE (65162-711-10)

Ingredients (1)

guanfacine hydrochloride (1 mg/1)

Linked Drug Pages (1)

Guanfacine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2742ab0e-0dcc-4be7-8356-ea7ba8dfe6a7", "openfda": {"upc": ["0365162713039", "0365162711035"], "unii": ["PML56A160O"], "rxcui": ["197745", "197746"], "spl_set_id": ["d9fdc4b4-5b00-46dd-8700-6e36ceaafb0e"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (65162-711-03)", "package_ndc": "65162-711-03", "marketing_start_date": "19981125"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (65162-711-10)", "package_ndc": "65162-711-10", "marketing_start_date": "19981125"}], "brand_name": "Guanfacine Hydrochloride", "product_id": "65162-711_2742ab0e-0dcc-4be7-8356-ea7ba8dfe6a7", "dosage_form": "TABLET", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]"], "product_ndc": "65162-711", "generic_name": "Guanfacine", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Guanfacine Hydrochloride", "active_ingredients": [{"name": "GUANFACINE HYDROCHLORIDE", "strength": "1 mg/1"}], "application_number": "ANDA075109", "marketing_category": "ANDA", "marketing_start_date": "19981125", "listing_expiration_date": "20261231"}