guanfacine

Generic: guanfacine

Labeler: sun pharmaceutical industries, inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name guanfacine
Generic Name guanfacine
Labeler sun pharmaceutical industries, inc
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

guanfacine hydrochloride 4 mg/1

Manufacturer
Sun Pharmaceutical Industries, Inc

Identifiers & Regulatory

Product NDC 63304-927
Product ID 63304-927_2a401634-d240-7d00-e063-6394a90abb3c
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 63304927
Hyphenated Format 63304-927

Supplemental Identifiers

RxCUI
862006 862013 862019 862025
UPC
0363304925012 0363304926019 0363304927016 0363304924015
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 (source: ndc)
Application Number ANDA205689 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (63304-927-01)
  • 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (63304-927-05)
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (63304-927-30)
source: ndc

Packages (3)

63304-927-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (63304-927-01) 63304-927-05 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (63304-927-05) 63304-927-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (63304-927-30)

Ingredients (1)

guanfacine hydrochloride (4 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": "2a401634-d240-7d00-e063-6394a90abb3c", "openfda": {"upc": ["0363304925012", "0363304926019", "0363304927016", "0363304924015"], "unii": ["PML56A160O"], "rxcui": ["862006", "862013", "862019", "862025"], "spl_set_id": ["2d0a0f8e-5098-4ee2-a4ee-d026789923e2"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (63304-927-01)", "package_ndc": "63304-927-01", "marketing_start_date": "20180817"}, {"sample": false, "description": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (63304-927-05)", "package_ndc": "63304-927-05", "marketing_start_date": "20180817"}, {"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (63304-927-30)", "package_ndc": "63304-927-30", "marketing_start_date": "20180817"}], "brand_name": "Guanfacine", "product_id": "63304-927_2a401634-d240-7d00-e063-6394a90abb3c", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]"], "product_ndc": "63304-927", "generic_name": "Guanfacine", "labeler_name": "Sun Pharmaceutical Industries, Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Guanfacine", "active_ingredients": [{"name": "GUANFACINE HYDROCHLORIDE", "strength": "4 mg/1"}], "application_number": "ANDA205689", "marketing_category": "ANDA", "marketing_start_date": "20180817", "listing_expiration_date": "20261231"}