chlorthalidone

Generic: chlorthalidone

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name chlorthalidone
Generic Name chlorthalidone
Labeler sun pharmaceutical industries, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

chlorthalidone 25 mg/1

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 57664-648
Product ID 57664-648_eca591c9-75f8-2cbb-e053-2a95a90a7cf4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA089286
Listing Expiration 2026-12-31
Marketing Start 2016-02-12

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 57664648
Hyphenated Format 57664-648

Supplemental Identifiers

RxCUI
197499 197500
UPC
0357664648889 0357664649886
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 ANDA089286 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 1000 TABLET in 1 BOTTLE (57664-648-18)
  • 100 TABLET in 1 BOTTLE (57664-648-88)
source: ndc

Packages (2)

57664-648-18 1000 TABLET in 1 BOTTLE (57664-648-18) 57664-648-88 100 TABLET in 1 BOTTLE (57664-648-88)

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": "eca591c9-75f8-2cbb-e053-2a95a90a7cf4", "openfda": {"nui": ["N0000175359", "N0000175420"], "upc": ["0357664648889", "0357664649886"], "unii": ["Q0MQD1073Q"], "rxcui": ["197499", "197500"], "spl_set_id": ["a304de67-cd2b-4933-937e-4eeecf6cda40"], "pharm_class_pe": ["Increased Diuresis [PE]"], "pharm_class_epc": ["Thiazide-like Diuretic [EPC]"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET in 1 BOTTLE (57664-648-18)", "package_ndc": "57664-648-18", "marketing_start_date": "20221104"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (57664-648-88)", "package_ndc": "57664-648-88", "marketing_start_date": "20160212"}], "brand_name": "Chlorthalidone", "product_id": "57664-648_eca591c9-75f8-2cbb-e053-2a95a90a7cf4", "dosage_form": "TABLET", "pharm_class": ["Increased Diuresis [PE]", "Thiazide-like Diuretic [EPC]"], "product_ndc": "57664-648", "generic_name": "Chlorthalidone", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Chlorthalidone", "active_ingredients": [{"name": "CHLORTHALIDONE", "strength": "25 mg/1"}], "application_number": "ANDA089286", "marketing_category": "ANDA", "marketing_start_date": "20160212", "listing_expiration_date": "20261231"}