clonidine hydrochloride

Generic: clonidine hydrochloride

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name clonidine hydrochloride
Generic Name clonidine hydrochloride
Labeler aphena pharma solutions - tennessee, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

clonidine hydrochloride .3 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 43353-316
Product ID 43353-316_2bf1938a-b415-4fb4-bb25-c3fc89ed1462
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA070976
Listing Expiration 2026-12-31
Marketing Start 1995-01-03

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 43353316
Hyphenated Format 43353-316

Supplemental Identifiers

RxCUI
884189
UNII
W76I6XXF06

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 clonidine hydrochloride (source: ndc)
Generic Name clonidine hydrochloride (source: ndc)
Application Number ANDA070976 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .3 mg/1
source: ndc
Packaging
  • 9000 TABLET in 1 BOTTLE (43353-316-09)
source: ndc

Packages (1)

43353-316-09 9000 TABLET in 1 BOTTLE (43353-316-09)

Ingredients (1)

clonidine hydrochloride (.3 mg/1)

Linked Drug Pages (1)

Clonidine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2bf1938a-b415-4fb4-bb25-c3fc89ed1462", "openfda": {"unii": ["W76I6XXF06"], "rxcui": ["884189"], "spl_set_id": ["e9b22c56-a3fc-46df-b745-11c4ac309a91"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "9000 TABLET in 1 BOTTLE (43353-316-09)", "package_ndc": "43353-316-09", "marketing_start_date": "20170503"}], "brand_name": "Clonidine Hydrochloride", "product_id": "43353-316_2bf1938a-b415-4fb4-bb25-c3fc89ed1462", "dosage_form": "TABLET", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]"], "product_ndc": "43353-316", "generic_name": "Clonidine Hydrochloride", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Clonidine Hydrochloride", "active_ingredients": [{"name": "CLONIDINE HYDROCHLORIDE", "strength": ".3 mg/1"}], "application_number": "ANDA070976", "marketing_category": "ANDA", "marketing_start_date": "19950103", "listing_expiration_date": "20261231"}