guanfacine extended-release

Generic: guanfacine

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

Drug Facts

Product Profile

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

guanfacine hydrochloride 2 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 71335-9750
Product ID 71335-9750_9de936f2-fd38-401b-a195-960f037b5e8c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205430
Listing Expiration 2027-12-31
Marketing Start 2018-10-03

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 713359750
Hyphenated Format 71335-9750

Supplemental Identifiers

RxCUI
862013
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 extended-release (source: ndc)
Generic Name guanfacine (source: ndc)
Application Number ANDA205430 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-9750-1)
  • 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-9750-2)
source: ndc

Packages (2)

71335-9750-1 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-9750-1) 71335-9750-2 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-9750-2)

Ingredients (1)

guanfacine hydrochloride (2 mg/1)

Linked Drug Pages (1)

Guanfacine extended-release ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "9de936f2-fd38-401b-a195-960f037b5e8c", "openfda": {"unii": ["PML56A160O"], "rxcui": ["862013"], "spl_set_id": ["07cda4a1-0eb5-491e-8d16-4e6a6feb93ac"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-9750-1)", "package_ndc": "71335-9750-1", "marketing_start_date": "20230710"}, {"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-9750-2)", "package_ndc": "71335-9750-2", "marketing_start_date": "20241004"}], "brand_name": "Guanfacine extended-release", "product_id": "71335-9750_9de936f2-fd38-401b-a195-960f037b5e8c", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]"], "product_ndc": "71335-9750", "generic_name": "guanfacine", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Guanfacine extended-release", "active_ingredients": [{"name": "GUANFACINE HYDROCHLORIDE", "strength": "2 mg/1"}], "application_number": "ANDA205430", "marketing_category": "ANDA", "marketing_start_date": "20181003", "listing_expiration_date": "20271231"}