guanfacine extended-release

Generic: guanfacine

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name guanfacine extended-release
Generic Name guanfacine
Labeler proficient rx lp
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

guanfacine 4 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 71205-947
Product ID 71205-947_6de48883-f40b-4aef-83d4-6acb86c1b11e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201408
Listing Expiration 2026-12-31
Marketing Start 2017-07-07

Pharmacologic Class

Established (EPC)
central alpha-2 adrenergic agonist [epc]
Mechanism of Action
adrenergic alpha2-agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71205947
Hyphenated Format 71205-947

Supplemental Identifiers

RxCUI
862006 862013 862019 862025
UPC
0371205947309 0371205946302 0371205945305
UNII
30OMY4G3MK
NUI
N0000009918 N0000175554

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 ANDA201408 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-947-00)
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-947-30)
  • 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-947-55)
  • 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-947-60)
  • 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-947-90)
source: ndc

Packages (5)

71205-947-00 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-947-00) 71205-947-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-947-30) 71205-947-55 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-947-55) 71205-947-60 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-947-60) 71205-947-90 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-947-90)

Ingredients (1)

guanfacine (4 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": "6de48883-f40b-4aef-83d4-6acb86c1b11e", "openfda": {"nui": ["N0000009918", "N0000175554"], "upc": ["0371205947309", "0371205946302", "0371205945305"], "unii": ["30OMY4G3MK"], "rxcui": ["862006", "862013", "862019", "862025"], "spl_set_id": ["6460ad33-4feb-4a4d-9958-501084046389"], "pharm_class_epc": ["Central alpha-2 Adrenergic Agonist [EPC]"], "pharm_class_moa": ["Adrenergic alpha2-Agonists [MoA]"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-947-00)", "package_ndc": "71205-947-00", "marketing_start_date": "20201119"}, {"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-947-30)", "package_ndc": "71205-947-30", "marketing_start_date": "20201119"}, {"sample": false, "description": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-947-55)", "package_ndc": "71205-947-55", "marketing_start_date": "20201119"}, {"sample": false, "description": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-947-60)", "package_ndc": "71205-947-60", "marketing_start_date": "20201119"}, {"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-947-90)", "package_ndc": "71205-947-90", "marketing_start_date": "20201119"}], "brand_name": "Guanfacine Extended-Release", "product_id": "71205-947_6de48883-f40b-4aef-83d4-6acb86c1b11e", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]"], "product_ndc": "71205-947", "generic_name": "Guanfacine", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Guanfacine", "brand_name_suffix": "Extended-Release", "active_ingredients": [{"name": "GUANFACINE", "strength": "4 mg/1"}], "application_number": "ANDA201408", "marketing_category": "ANDA", "marketing_start_date": "20170707", "listing_expiration_date": "20261231"}