FDA.reportPublic FDA data

Thalitone

Product NDC
70199-001
Requested package NDC
70199-001-30
11-digit product format
701990001
Labeler code
70199
Product ID
70199-001_fbaeb9d5-4b22-4528-9421-9954e53887c9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
chlorthalidone
Dosage form
TABLET
Route
ORAL
Labeler
Casper Pharma LLC
Application
NDA019574
Marketing category
NDA
Marketing start
2019-11-27
Substance
CHLORTHALIDONE
Active strength
25 mg/1
Pharmacologic classes
Increased Diuresis [PE], Thiazide-like Diuretic [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage70199-00170199-001-30DDiscontinued by firm2026-08-03

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N019574-001THALITONECHLORTHALIDONE15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1988-12-20
N019574-002THALITONECHLORTHALIDONE25MGTABLET / ORALRLD1992-02-12

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N019574-001THALITONE15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1988-12-20a50c72e98297…
2026-08-01 22:54:322026-06N019574-002THALITONE25MGTABLET / ORALRLD1992-02-12a50c72e98297…

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. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ThalitoneCHLORTHALIDONECasper Pharma LLCbc5a0299-115b-4e60-bb3f-c75a95c51c152026-06-25Warnings, Adverse reactionsExact identifier
application applno (NDA): 019574
application number: NDA019574
ndc (package): 70199-001-30
ndc (product): 70199-001
ndc11 (package): 70199000130

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
83fe98fe-2a14-448c-9029-41f7600d1b0aProduct name120260105
0450926f-f624-49c2-83be-42807e8fbcd5Product name120251113
8525e779-537f-e5cc-2515-089ecce5f50fProduct name920221128
faf41ef3-b4b3-a29e-3b26-07c3009003bfProduct name520220517
3f5e2da3-8b99-f714-3261-2c998ee07b05Product name120140508
7667d8e2-e5be-36e1-4de7-231aa7fdaf5cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70199-001-01Thalitone100 in 1 BOTTLETABLET1006
70199-001-30Thalitone30 in 1 BOTTLETABLET306

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70199-001THALITONE (CHLORTHALIDONE) TABLET THALITONE (CHLORTHALIDONE) TABLET [CASPER PHARMA LLC]6Current NDC, Legacy NDC, 2 package rows20210617_bc5a0299-115b-4e60-bb3f-c75a95c51c15.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197498chlorthalidone 15 MG Oral TabletPSNbc5a0299-115b-4e60-bb3f-c75a95c51c156
197499chlorthalidone 25 MG Oral TabletPSNbc5a0299-115b-4e60-bb3f-c75a95c51c156
214081THALITONE 15 MG Oral TabletPSNbc5a0299-115b-4e60-bb3f-c75a95c51c156
214083THALITONE 25 MG Oral TabletPSNbc5a0299-115b-4e60-bb3f-c75a95c51c156
214081chlorthalidone 15 MG Oral Tablet [Thalitone]SBDbc5a0299-115b-4e60-bb3f-c75a95c51c156
214083chlorthalidone 25 MG Oral Tablet [Thalitone]SBDbc5a0299-115b-4e60-bb3f-c75a95c51c156
197498chlorthalidone 15 MG Oral TabletSCDbc5a0299-115b-4e60-bb3f-c75a95c51c156
197499chlorthalidone 25 MG Oral TabletSCDbc5a0299-115b-4e60-bb3f-c75a95c51c156
214081Thalitone 15 MG Oral TabletSYbc5a0299-115b-4e60-bb3f-c75a95c51c156
214083Thalitone 25 MG Oral TabletSYbc5a0299-115b-4e60-bb3f-c75a95c51c156

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70199-001-307019900013030 TABLET in 1 BOTTLE (70199-001-30) 30 tablet2019-11-270000-00-00NoNoCurrent