guanfacine hydrochloride

Generic: guanfacine

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

Drug Facts

Product Profile

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

guanfacine hydrochloride 2 mg/1

Manufacturer
Amneal Pharmaceuticals of New York LLC

Identifiers & Regulatory

Product NDC 53746-713
Product ID 53746-713_bd665bca-22a6-4ebe-8a61-f47ce397e7f3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075109
Listing Expiration 2026-12-31
Marketing Start 2022-04-15

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 53746713
Hyphenated Format 53746-713

Supplemental Identifiers

RxCUI
197745 197746
UPC
0353746711014
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
  • 2 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (53746-713-01)
source: ndc

Packages (1)

53746-713-01 100 TABLET in 1 BOTTLE (53746-713-01)

Ingredients (1)

guanfacine hydrochloride (2 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": "bd665bca-22a6-4ebe-8a61-f47ce397e7f3", "openfda": {"upc": ["0353746711014"], "unii": ["PML56A160O"], "rxcui": ["197745", "197746"], "spl_set_id": ["73d50917-c807-4213-8efe-aea209845936"], "manufacturer_name": ["Amneal Pharmaceuticals of New York LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (53746-713-01)", "package_ndc": "53746-713-01", "marketing_start_date": "20220415"}], "brand_name": "Guanfacine Hydrochloride", "product_id": "53746-713_bd665bca-22a6-4ebe-8a61-f47ce397e7f3", "dosage_form": "TABLET", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]"], "product_ndc": "53746-713", "generic_name": "Guanfacine", "labeler_name": "Amneal Pharmaceuticals of New York LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Guanfacine Hydrochloride", "active_ingredients": [{"name": "GUANFACINE HYDROCHLORIDE", "strength": "2 mg/1"}], "application_number": "ANDA075109", "marketing_category": "ANDA", "marketing_start_date": "20220415", "listing_expiration_date": "20261231"}