guanfacine extended-release

Generic: guanfacine

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

Drug Facts

Product Profile

Brand Name guanfacine extended-release
Generic Name guanfacine
Labeler remedyrepack inc.
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

guanfacine hydrochloride 2 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-4266
Product ID 70518-4266_400a2b11-b85e-cbb6-e063-6294a90a5242
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205430
Listing Expiration 2026-12-31
Marketing Start 2025-01-27

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 705184266
Hyphenated Format 70518-4266

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
  • 100 POUCH in 1 BOX (70518-4266-0) / 1 TABLET, EXTENDED RELEASE in 1 POUCH (70518-4266-1)
source: ndc

Packages (1)

70518-4266-0 100 POUCH in 1 BOX (70518-4266-0) / 1 TABLET, EXTENDED RELEASE in 1 POUCH (70518-4266-1)

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": "400a2b11-b85e-cbb6-e063-6294a90a5242", "openfda": {"unii": ["PML56A160O"], "rxcui": ["862013"], "spl_set_id": ["8348e63a-5cbc-489e-b7bf-046c65ba2e8e"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "100 POUCH in 1 BOX (70518-4266-0)  / 1 TABLET, EXTENDED RELEASE in 1 POUCH (70518-4266-1)", "package_ndc": "70518-4266-0", "marketing_start_date": "20250127"}], "brand_name": "Guanfacine extended-release", "product_id": "70518-4266_400a2b11-b85e-cbb6-e063-6294a90a5242", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]"], "product_ndc": "70518-4266", "generic_name": "guanfacine", "labeler_name": "REMEDYREPACK INC.", "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": "20250127", "listing_expiration_date": "20261231"}