guanfacine

Generic: guanfacine

Labeler: remedyrepack inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name guanfacine
Generic Name guanfacine
Labeler remedyrepack inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

guanfacine hydrochloride 2 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-4488
Product ID 70518-4488_4009ab4c-4e58-ea2b-e063-6294a90a26f3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217293
Listing Expiration 2026-12-31
Marketing Start 2025-09-30

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 705184488
Hyphenated Format 70518-4488

Supplemental Identifiers

RxCUI
197746
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 ANDA217293 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BLISTER PACK (70518-4488-0)
source: ndc

Packages (1)

70518-4488-0 30 TABLET in 1 BLISTER PACK (70518-4488-0)

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": "4009ab4c-4e58-ea2b-e063-6294a90a26f3", "openfda": {"unii": ["PML56A160O"], "rxcui": ["197746"], "spl_set_id": ["4248d53e-4dc3-452b-96f8-5d715c254c26"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BLISTER PACK (70518-4488-0)", "package_ndc": "70518-4488-0", "marketing_start_date": "20250930"}], "brand_name": "Guanfacine", "product_id": "70518-4488_4009ab4c-4e58-ea2b-e063-6294a90a26f3", "dosage_form": "TABLET", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]"], "product_ndc": "70518-4488", "generic_name": "Guanfacine", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Guanfacine", "active_ingredients": [{"name": "GUANFACINE HYDROCHLORIDE", "strength": "2 mg/1"}], "application_number": "ANDA217293", "marketing_category": "ANDA", "marketing_start_date": "20250930", "listing_expiration_date": "20261231"}