guanfacine hydrochloride

Generic: guanfacine

Labeler: chartwell rx, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name guanfacine hydrochloride
Generic Name guanfacine
Labeler chartwell rx, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

guanfacine hydrochloride 2 mg/1

Manufacturer
Chartwell RX, LLC

Identifiers & Regulatory

Product NDC 62135-728
Product ID 62135-728_459cdf6c-19fa-c506-e063-6394a90a7393
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216399
Listing Expiration 2026-12-31
Marketing Start 2022-09-01

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 62135728
Hyphenated Format 62135-728

Supplemental Identifiers

RxCUI
197745 197746
UPC
0362135728908 0362135727901
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 hydrochloride (source: ndc)
Generic Name guanfacine (source: ndc)
Application Number ANDA216399 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 90 TABLET in 1 BOTTLE (62135-728-90)
source: ndc

Packages (1)

62135-728-90 90 TABLET in 1 BOTTLE (62135-728-90)

Ingredients (1)

guanfacine hydrochloride (2 mg/1)

Linked Drug Pages (1)

GUANFACINE HYDROCHLORIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "459cdf6c-19fa-c506-e063-6394a90a7393", "openfda": {"upc": ["0362135728908", "0362135727901"], "unii": ["PML56A160O"], "rxcui": ["197745", "197746"], "spl_set_id": ["fa7ae501-ee34-4e50-9052-7952e36bbd0e"], "manufacturer_name": ["Chartwell RX, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET in 1 BOTTLE (62135-728-90)", "package_ndc": "62135-728-90", "marketing_start_date": "20230712"}], "brand_name": "GUANFACINE HYDROCHLORIDE", "product_id": "62135-728_459cdf6c-19fa-c506-e063-6394a90a7393", "dosage_form": "TABLET", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]"], "product_ndc": "62135-728", "generic_name": "guanfacine", "labeler_name": "Chartwell RX, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "GUANFACINE HYDROCHLORIDE", "active_ingredients": [{"name": "GUANFACINE HYDROCHLORIDE", "strength": "2 mg/1"}], "application_number": "ANDA216399", "marketing_category": "ANDA", "marketing_start_date": "20220901", "listing_expiration_date": "20261231"}