guanfacine

Generic: guanfacine

Labeler: northstar rxllc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name guanfacine
Generic Name guanfacine
Labeler northstar rxllc
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

guanfacine hydrochloride 1 mg/1

Manufacturer
NORTHSTAR RXLLC

Identifiers & Regulatory

Product NDC 16714-190
Product ID 16714-190_2a3f66a1-c942-7bba-e063-6394a90a05a1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205689
Listing Expiration 2026-12-31
Marketing Start 2021-09-17

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 16714190
Hyphenated Format 16714-190

Supplemental Identifiers

RxCUI
862006 862013 862019 862025
UPC
0316714191010 0316714192017
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
  • 1 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (16714-190-01)
source: ndc

Packages (1)

16714-190-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (16714-190-01)

Ingredients (1)

guanfacine hydrochloride (1 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": "2a3f66a1-c942-7bba-e063-6394a90a05a1", "openfda": {"upc": ["0316714191010", "0316714192017"], "unii": ["PML56A160O"], "rxcui": ["862006", "862013", "862019", "862025"], "spl_set_id": ["0b2afdab-8c92-463e-9734-f2c8b4200777"], "manufacturer_name": ["NORTHSTAR RXLLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (16714-190-01)", "package_ndc": "16714-190-01", "marketing_start_date": "20210917"}], "brand_name": "Guanfacine", "product_id": "16714-190_2a3f66a1-c942-7bba-e063-6394a90a05a1", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]"], "product_ndc": "16714-190", "generic_name": "Guanfacine", "labeler_name": "NORTHSTAR RXLLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Guanfacine", "active_ingredients": [{"name": "GUANFACINE HYDROCHLORIDE", "strength": "1 mg/1"}], "application_number": "ANDA205689", "marketing_category": "ANDA", "marketing_start_date": "20210917", "listing_expiration_date": "20261231"}