guanfacine

Generic: guanfacine

Labeler: unichem pharmaceuticals (usa), inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name guanfacine
Generic Name guanfacine
Labeler unichem pharmaceuticals (usa), inc.
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

guanfacine hydrochloride 2 mg/1

Manufacturer
Unichem Pharmaceuticals (USA), Inc.

Identifiers & Regulatory

Product NDC 29300-461
Product ID 29300-461_02271fb1-d7ad-49cb-a6a4-622e458e5db7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA219033
Listing Expiration 2026-12-31
Marketing Start 2024-11-19

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 29300461
Hyphenated Format 29300-461

Supplemental Identifiers

RxCUI
862006 862013 862019 862025
UPC
0329300460018 0329300463019 0329300461015
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 ANDA219033 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (29300-461-01)
source: ndc

Packages (1)

29300-461-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (29300-461-01)

Ingredients (1)

guanfacine hydrochloride (2 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": "02271fb1-d7ad-49cb-a6a4-622e458e5db7", "openfda": {"upc": ["0329300460018", "0329300463019", "0329300461015"], "unii": ["PML56A160O"], "rxcui": ["862006", "862013", "862019", "862025"], "spl_set_id": ["f4e3c976-8811-4388-92b3-d248d705f8b1"], "manufacturer_name": ["Unichem Pharmaceuticals (USA), Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (29300-461-01)", "package_ndc": "29300-461-01", "marketing_start_date": "20250201"}], "brand_name": "Guanfacine", "product_id": "29300-461_02271fb1-d7ad-49cb-a6a4-622e458e5db7", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]"], "product_ndc": "29300-461", "generic_name": "Guanfacine", "labeler_name": "Unichem Pharmaceuticals (USA), Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Guanfacine", "active_ingredients": [{"name": "GUANFACINE HYDROCHLORIDE", "strength": "2 mg/1"}], "application_number": "ANDA219033", "marketing_category": "ANDA", "marketing_start_date": "20241119", "listing_expiration_date": "20261231"}