guanfacine

Generic: guanfacine hydrochloride

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name guanfacine
Generic Name guanfacine hydrochloride
Labeler aurobindo pharma limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

guanfacine hydrochloride 1 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 59651-840
Product ID 59651-840_e6d4fc3d-4169-44f1-bcb9-1188de40d4e5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA074796
Listing Expiration 2026-12-31
Marketing Start 2023-08-07

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 59651840
Hyphenated Format 59651-840

Supplemental Identifiers

RxCUI
197745 197746
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 (source: ndc)
Generic Name guanfacine hydrochloride (source: ndc)
Application Number ANDA074796 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (59651-840-01)
source: ndc

Packages (1)

59651-840-01 100 TABLET in 1 BOTTLE (59651-840-01)

Ingredients (1)

guanfacine hydrochloride (1 mg/1)

Linked Drug Pages (1)

GUANFACINE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "e6d4fc3d-4169-44f1-bcb9-1188de40d4e5", "openfda": {"unii": ["PML56A160O"], "rxcui": ["197745", "197746"], "spl_set_id": ["e6d4fc3d-4169-44f1-bcb9-1188de40d4e5"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (59651-840-01)", "package_ndc": "59651-840-01", "marketing_start_date": "20230807"}], "brand_name": "GUANFACINE", "product_id": "59651-840_e6d4fc3d-4169-44f1-bcb9-1188de40d4e5", "dosage_form": "TABLET", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]"], "product_ndc": "59651-840", "generic_name": "GUANFACINE HYDROCHLORIDE", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "GUANFACINE", "active_ingredients": [{"name": "GUANFACINE HYDROCHLORIDE", "strength": "1 mg/1"}], "application_number": "ANDA074796", "marketing_category": "ANDA", "marketing_start_date": "20230807", "listing_expiration_date": "20261231"}