chlorthalidone chlorthalidone

Generic: chlorthalidone

Labeler: alembic pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name chlorthalidone chlorthalidone
Generic Name chlorthalidone
Labeler alembic pharmaceuticals limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

chlorthalidone 25 mg/1

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-676
Product ID 46708-676_1b98d1a1-9d3d-41d2-a5e9-744b851d30d4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216262
Listing Expiration 2026-12-31
Marketing Start 2022-08-29

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 46708676
Hyphenated Format 46708-676

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 chlorthalidone (source: ndc)
Generic Name chlorthalidone (source: ndc)
Application Number ANDA216262 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (46708-676-31)
  • 90 TABLET in 1 BOTTLE (46708-676-90)
  • 1000 TABLET in 1 BOTTLE (46708-676-91)
source: ndc

Packages (3)

46708-676-31 100 TABLET in 1 BOTTLE (46708-676-31) 46708-676-90 90 TABLET in 1 BOTTLE (46708-676-90) 46708-676-91 1000 TABLET in 1 BOTTLE (46708-676-91)

Ingredients (1)

chlorthalidone (25 mg/1)

Linked Drug Pages (1)

CHLORTHALIDONE CHLORTHALIDONE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "1b98d1a1-9d3d-41d2-a5e9-744b851d30d4", "openfda": {"nui": ["N0000175359", "N0000175420"], "unii": ["Q0MQD1073Q"], "rxcui": ["197499", "197500"], "spl_set_id": ["1b98d1a1-9d3d-41d2-a5e9-744b851d30d4"], "pharm_class_pe": ["Increased Diuresis [PE]"], "pharm_class_epc": ["Thiazide-like Diuretic [EPC]"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (46708-676-31)", "package_ndc": "46708-676-31", "marketing_start_date": "20220829"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (46708-676-90)", "package_ndc": "46708-676-90", "marketing_start_date": "20220829"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (46708-676-91)", "package_ndc": "46708-676-91", "marketing_start_date": "20220829"}], "brand_name": "CHLORTHALIDONE CHLORTHALIDONE", "product_id": "46708-676_1b98d1a1-9d3d-41d2-a5e9-744b851d30d4", "dosage_form": "TABLET", "pharm_class": ["Increased Diuresis [PE]", "Thiazide-like Diuretic [EPC]"], "product_ndc": "46708-676", "generic_name": "CHLORTHALIDONE", "labeler_name": "Alembic Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "CHLORTHALIDONE", "brand_name_suffix": "CHLORTHALIDONE", "active_ingredients": [{"name": "CHLORTHALIDONE", "strength": "25 mg/1"}], "application_number": "ANDA216262", "marketing_category": "ANDA", "marketing_start_date": "20220829", "listing_expiration_date": "20261231"}