chlorthalidone

Generic: chlorthalidone

Labeler: amneal pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name chlorthalidone
Generic Name chlorthalidone
Labeler amneal pharmaceuticals llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

chlorthalidone 50 mg/1

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 65162-250
Product ID 65162-250_6489aee4-4593-4cc5-97dc-24a7a2eaab67
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207204
Listing Expiration 2026-12-31
Marketing Start 2019-07-01

Pharmacologic Class

Established (EPC)
thiazide-like diuretic [epc]
Physiologic Effect
increased diuresis [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65162250
Hyphenated Format 65162-250

Supplemental Identifiers

RxCUI
197499 197500
UNII
Q0MQD1073Q
NUI
N0000175359 N0000175420

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 chlorthalidone (source: ndc)
Generic Name chlorthalidone (source: ndc)
Application Number ANDA207204 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (65162-250-03)
  • 90 TABLET in 1 BOTTLE (65162-250-09)
source: ndc

Packages (2)

65162-250-03 30 TABLET in 1 BOTTLE (65162-250-03) 65162-250-09 90 TABLET in 1 BOTTLE (65162-250-09)

Ingredients (1)

chlorthalidone (50 mg/1)

Linked Drug Pages (1)

Chlorthalidone ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "6489aee4-4593-4cc5-97dc-24a7a2eaab67", "openfda": {"nui": ["N0000175359", "N0000175420"], "unii": ["Q0MQD1073Q"], "rxcui": ["197499", "197500"], "spl_set_id": ["c4c1bfe5-b5c8-43c0-9428-62337095b2bd"], "pharm_class_pe": ["Increased Diuresis [PE]"], "pharm_class_epc": ["Thiazide-like Diuretic [EPC]"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (65162-250-03)", "package_ndc": "65162-250-03", "marketing_start_date": "20190701"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (65162-250-09)", "package_ndc": "65162-250-09", "marketing_start_date": "20190701"}], "brand_name": "Chlorthalidone", "product_id": "65162-250_6489aee4-4593-4cc5-97dc-24a7a2eaab67", "dosage_form": "TABLET", "pharm_class": ["Increased Diuresis [PE]", "Thiazide-like Diuretic [EPC]"], "product_ndc": "65162-250", "generic_name": "Chlorthalidone", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Chlorthalidone", "active_ingredients": [{"name": "CHLORTHALIDONE", "strength": "50 mg/1"}], "application_number": "ANDA207204", "marketing_category": "ANDA", "marketing_start_date": "20190701", "listing_expiration_date": "20261231"}