guanfacine hydrochloride

Generic: guanfacine hydrochloride

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

Drug Facts

Product Profile

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

guanfacine hydrochloride 2 mg/1

Manufacturer
XIROMED, LLC

Identifiers & Regulatory

Product NDC 70700-302
Product ID 70700-302_23ee7a86-0dc4-c845-93ff-f02aab00ce8f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218326
Listing Expiration 2026-12-31
Marketing Start 2024-02-24

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 70700302
Hyphenated Format 70700-302

Supplemental Identifiers

RxCUI
197745 197746
UPC
0370700302057 0370700301012 0370700302309 0370700301302 0370700302019
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 hydrochloride (source: ndc)
Application Number ANDA218326 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (70700-302-01)
  • 500 TABLET in 1 BOTTLE (70700-302-05)
  • 30 TABLET in 1 BOTTLE (70700-302-30)
source: ndc

Packages (3)

70700-302-01 100 TABLET in 1 BOTTLE (70700-302-01) 70700-302-05 500 TABLET in 1 BOTTLE (70700-302-05) 70700-302-30 30 TABLET in 1 BOTTLE (70700-302-30)

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": "23ee7a86-0dc4-c845-93ff-f02aab00ce8f", "openfda": {"upc": ["0370700302057", "0370700301012", "0370700302309", "0370700301302", "0370700302019"], "unii": ["PML56A160O"], "rxcui": ["197745", "197746"], "spl_set_id": ["4f1e668a-37dd-44f4-ae99-3a1f6dba3eea"], "manufacturer_name": ["XIROMED, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (70700-302-01)", "package_ndc": "70700-302-01", "marketing_start_date": "20240224"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (70700-302-05)", "package_ndc": "70700-302-05", "marketing_start_date": "20240224"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (70700-302-30)", "package_ndc": "70700-302-30", "marketing_start_date": "20240224"}], "brand_name": "Guanfacine Hydrochloride", "product_id": "70700-302_23ee7a86-0dc4-c845-93ff-f02aab00ce8f", "dosage_form": "TABLET", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]"], "product_ndc": "70700-302", "generic_name": "Guanfacine Hydrochloride", "labeler_name": "XIROMED, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Guanfacine Hydrochloride", "active_ingredients": [{"name": "GUANFACINE HYDROCHLORIDE", "strength": "2 mg/1"}], "application_number": "ANDA218326", "marketing_category": "ANDA", "marketing_start_date": "20240224", "listing_expiration_date": "20261231"}