guanfacine hydrochloride

Generic: guanfacine hydrochloride

Labeler: unichem pharmaceuticals (usa), inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name guanfacine hydrochloride
Generic Name guanfacine hydrochloride
Labeler unichem pharmaceuticals (usa), inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

guanfacine 1 mg/1

Manufacturer
Unichem Pharmaceuticals (USA), Inc.

Identifiers & Regulatory

Product NDC 29300-458
Product ID 29300-458_9df9e7f8-a9b3-4919-94f9-07c81ff7c8b3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214689
Listing Expiration 2026-12-31
Marketing Start 2021-03-03

Pharmacologic Class

Established (EPC)
central alpha-2 adrenergic agonist [epc]
Mechanism of Action
adrenergic alpha2-agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 29300458
Hyphenated Format 29300-458

Supplemental Identifiers

RxCUI
197745 197746
UNII
30OMY4G3MK
NUI
N0000009918 N0000175554

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 ANDA214689 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (29300-458-01)
source: ndc

Packages (1)

29300-458-01 100 TABLET in 1 BOTTLE (29300-458-01)

Ingredients (1)

guanfacine (1 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": "9df9e7f8-a9b3-4919-94f9-07c81ff7c8b3", "openfda": {"nui": ["N0000009918", "N0000175554"], "unii": ["30OMY4G3MK"], "rxcui": ["197745", "197746"], "spl_set_id": ["14146031-8d56-469b-8de8-fe3cf1712e78"], "pharm_class_epc": ["Central alpha-2 Adrenergic Agonist [EPC]"], "pharm_class_moa": ["Adrenergic alpha2-Agonists [MoA]"], "manufacturer_name": ["Unichem Pharmaceuticals (USA), Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (29300-458-01)", "package_ndc": "29300-458-01", "marketing_start_date": "20210405"}], "brand_name": "Guanfacine Hydrochloride", "product_id": "29300-458_9df9e7f8-a9b3-4919-94f9-07c81ff7c8b3", "dosage_form": "TABLET", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]"], "product_ndc": "29300-458", "generic_name": "Guanfacine Hydrochloride", "labeler_name": "Unichem Pharmaceuticals (USA), Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Guanfacine Hydrochloride", "active_ingredients": [{"name": "GUANFACINE", "strength": "1 mg/1"}], "application_number": "ANDA214689", "marketing_category": "ANDA", "marketing_start_date": "20210303", "listing_expiration_date": "20261231"}