guanfacine

Generic: guanfacine

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name guanfacine
Generic Name guanfacine
Labeler bryant ranch prepack
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

guanfacine hydrochloride 1 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 63629-8161
Product ID 63629-8161_846438f0-3355-4455-a7e8-f0db48bc6162
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205689
Listing Expiration 2026-12-31
Marketing Start 2018-08-17

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 636298161
Hyphenated Format 63629-8161

Supplemental Identifiers

RxCUI
862006
UNII
PML56A160O

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 (source: ndc)
Application Number ANDA205689 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-8161-1)
source: ndc

Packages (1)

63629-8161-1 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-8161-1)

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": "846438f0-3355-4455-a7e8-f0db48bc6162", "openfda": {"unii": ["PML56A160O"], "rxcui": ["862006"], "spl_set_id": ["f070a54a-2738-4ef2-a98a-f9e7a7a56f55"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-8161-1)", "package_ndc": "63629-8161-1", "marketing_start_date": "20190702"}], "brand_name": "Guanfacine", "product_id": "63629-8161_846438f0-3355-4455-a7e8-f0db48bc6162", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]"], "product_ndc": "63629-8161", "generic_name": "Guanfacine", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Guanfacine", "active_ingredients": [{"name": "GUANFACINE HYDROCHLORIDE", "strength": "1 mg/1"}], "application_number": "ANDA205689", "marketing_category": "ANDA", "marketing_start_date": "20180817", "listing_expiration_date": "20261231"}