chlorthalidone

Generic: chlorthalidone

Labeler: nivagen pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name chlorthalidone
Generic Name chlorthalidone
Labeler nivagen pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

chlorthalidone 25 mg/1

Manufacturer
Nivagen Pharmaceuticals, INC.

Identifiers & Regulatory

Product NDC 75834-109
Product ID 75834-109_4581106c-4e01-7df9-e063-6294a90ac29f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207222
Listing Expiration 2026-12-31
Marketing Start 2018-05-28

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 75834109
Hyphenated Format 75834-109

Supplemental Identifiers

RxCUI
197499 197500
UPC
0375834109015 0375834110011
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 ANDA207222 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (75834-109-01)
  • 1000 TABLET in 1 BOTTLE (75834-109-10)
source: ndc

Packages (2)

75834-109-01 100 TABLET in 1 BOTTLE (75834-109-01) 75834-109-10 1000 TABLET in 1 BOTTLE (75834-109-10)

Ingredients (1)

chlorthalidone (25 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": "4581106c-4e01-7df9-e063-6294a90ac29f", "openfda": {"nui": ["N0000175359", "N0000175420"], "upc": ["0375834109015", "0375834110011"], "unii": ["Q0MQD1073Q"], "rxcui": ["197499", "197500"], "spl_set_id": ["36ef8d83-45f2-4873-b7cb-1be096d14d18"], "pharm_class_pe": ["Increased Diuresis [PE]"], "pharm_class_epc": ["Thiazide-like Diuretic [EPC]"], "manufacturer_name": ["Nivagen Pharmaceuticals, INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (75834-109-01)", "package_ndc": "75834-109-01", "marketing_start_date": "20180528"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (75834-109-10)", "package_ndc": "75834-109-10", "marketing_start_date": "20180528"}], "brand_name": "Chlorthalidone", "product_id": "75834-109_4581106c-4e01-7df9-e063-6294a90ac29f", "dosage_form": "TABLET", "pharm_class": ["Increased Diuresis [PE]", "Thiazide-like Diuretic [EPC]"], "product_ndc": "75834-109", "generic_name": "Chlorthalidone", "labeler_name": "Nivagen Pharmaceuticals, INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Chlorthalidone", "active_ingredients": [{"name": "CHLORTHALIDONE", "strength": "25 mg/1"}], "application_number": "ANDA207222", "marketing_category": "ANDA", "marketing_start_date": "20180528", "listing_expiration_date": "20261231"}