Chlorthalidone

Product NDC
63629-6347
11-digit product format
636296347
Labeler code
63629
Product ID
63629-6347_fec18d79-a58d-4c22-bb64-c390659344b5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
chlorthalidone
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA086831
Marketing category
ANDA
Marketing start
1981-02-26
Marketing end
0000-00-00
Substance
CHLORTHALIDONE
Active strength
25 mg/1
Pharmacologic classes
Thiazide-like Diuretic [EPC],Increased Diuresis [PE]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63629-6347DDiscontinued by firm2026-07-31
excluded packagepackage63629-634763629-6347-1DDiscontinued by firm2026-07-31
excluded packagepackage63629-634763629-6347-2DDiscontinued by firm2026-07-31
excluded packagepackage63629-634763629-6347-3DDiscontinued by firm2026-07-31

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A086831-001CHLORTHALIDONECHLORTHALIDONE50MGTABLET / ORALABRLD, RS, Approved before 1982
A086831-002CHLORTHALIDONECHLORTHALIDONE25MGTABLET / ORALABRLD, Approved before 1982

Therapeutic equivalence codes#

Application-product, TE code table
Application-productTE code
A086831-001AB
A086831-002AB

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ChlorthalidoneCHLORTHALIDONEPD-Rx Pharmaceuticals, Inc.bb7112ae-3a37-4525-8c7f-c0f4100ffc0a2026-06-12Warnings, Adverse reactionsExact identifier
ChlorthalidoneCHLORTHALIDONESafecor Health, LLCe0e316f6-96d1-4a89-a3b9-f4f0b4c9c8332026-04-03Warnings, Adverse reactionsExact identifier
ChlorthalidoneCHLORTHALIDONEMylan Pharmaceuticals Inc.15dd224a-87ad-48dc-80b1-e8382a452c4c2026-04-02Warnings, Adverse reactionsExact identifier
ChlorthalidoneCHLORTHALIDONEMylan Institutional Inc.193c85ba-43c2-4be2-82cf-7b394a83390e2026-01-20Warnings, Adverse reactionsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

WARNINGS Chlorthalidone should be used with caution in severe renal disease. In patients with renal disease, chlorthalidone or related drugs may precipitate azotemia. Cumulative effects of the drug may develop in patients with impaired renal function. Chlorthalidone should be used with caution in patients with impaired hepatic function or progressive liver disease, since minor alterations of fluid and electrolyte balance may precipitate hepatic coma. Sensitivity reactions may occur in patients with a history of allergy or bronchial asthma. The possibility of exacerbation or activation of systemic lupus erythematosus has been reported with thiazide diuretics, which are structurally related to chlorthalidone. However, systemic lupus erythematosus has not been reported following chlorthalidone administration.

Adverse reactions cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

adverse reactions

ADVERSE REACTIONS The following adverse reactions have been observed, but there is not enough systematic collection of data to support an estimate of their frequency. Gastrointestinal System Reactions: anorexia, gastric irritation, nausea, vomiting, cramping, diarrhea, constipation, jaundice (intrahepatic cholestatic jaundice), pancreatitis. Central Nervous System Reactions: dizziness, vertigo, paresthesias, headache, xanthopsia. Hematologic Reactions: leukopenia, agranulocytosis, thrombocytopenia, aplastic anemia. Dermatologic-Hypersensitivity Reactions: purpura, photosensitivity, rash, urticaria, necrotizing angiitis (vasculitis, cutaneous vasculitis), Lyell’s syndrome (toxic epidermal necrolysis). Cardiovascular Reactions: orthostatic hypotension may occur and may be aggravated by alcohol, barbiturates, or narcotics. Other Adverse Reactions: hyperglycemia, glycosuria, hyperuricemia, muscle spasm, weakness, restlessness, impotence. Whenever adverse reactions are moderate or severe, chlorthalidone dosage should be reduced or therapy withdrawn.

FDA-Initiated Inactive NDC Indexing#

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-6347-16362963470190 TABLET in 1 BOTTLE (63629-6347-1) 90 tablet2015-07-270000-00-00NoNoCurrent
63629-6347-26362963470230 TABLET in 1 BOTTLE (63629-6347-2) 30 tablet2015-09-010000-00-00NoNoCurrent
63629-6347-36362963470360 TABLET in 1 BOTTLE (63629-6347-3) 60 tablet2016-02-030000-00-00NoNoCurrent