chlorthalidone

Generic: chlorthalidone

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

Drug Facts

Product Profile

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

chlorthalidone 25 mg/1

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-0222
Product ID 0378-0222_0ffb0719-40b0-4fc8-b6a8-cc07d97cca29
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA086831
Listing Expiration 2026-12-31
Marketing Start 1981-02-26

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 03780222
Hyphenated Format 0378-0222

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 ANDA086831 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE, PLASTIC (0378-0222-01)
  • 1000 TABLET in 1 BOTTLE, PLASTIC (0378-0222-10)
source: ndc

Packages (2)

0378-0222-01 100 TABLET in 1 BOTTLE, PLASTIC (0378-0222-01) 0378-0222-10 1000 TABLET in 1 BOTTLE, PLASTIC (0378-0222-10)

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": "0ffb0719-40b0-4fc8-b6a8-cc07d97cca29", "openfda": {"nui": ["N0000175359", "N0000175420"], "unii": ["Q0MQD1073Q"], "rxcui": ["197499", "197500"], "spl_set_id": ["15dd224a-87ad-48dc-80b1-e8382a452c4c"], "pharm_class_pe": ["Increased Diuresis [PE]"], "pharm_class_epc": ["Thiazide-like Diuretic [EPC]"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (0378-0222-01)", "package_ndc": "0378-0222-01", "marketing_start_date": "19810226"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE, PLASTIC (0378-0222-10)", "package_ndc": "0378-0222-10", "marketing_start_date": "19810226"}], "brand_name": "Chlorthalidone", "product_id": "0378-0222_0ffb0719-40b0-4fc8-b6a8-cc07d97cca29", "dosage_form": "TABLET", "pharm_class": ["Increased Diuresis [PE]", "Thiazide-like Diuretic [EPC]"], "product_ndc": "0378-0222", "generic_name": "chlorthalidone", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Chlorthalidone", "active_ingredients": [{"name": "CHLORTHALIDONE", "strength": "25 mg/1"}], "application_number": "ANDA086831", "marketing_category": "ANDA", "marketing_start_date": "19810226", "listing_expiration_date": "20261231"}