FDA.reportPublic FDA data

Thalitone

Product NDC
70199-017
11-digit product format
701990017
Labeler code
70199
Product ID
70199-017_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
15 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

Additional Listing Data#

Finished product
Yes
Brand name base
Thalitone
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLORTHALIDONE15 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQ0MQD1073Q
Rxcui197498, 197499, 214081, 214083

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
70199-017-01Thalitone100 in 1 BOTTLETABLET1006
70199-017-30Thalitone30 in 1 BOTTLETABLET306

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70199-017-30EA - Each70199-0179c105029-2dc6-48d5-b602-e6815b9a615512021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70199-017THALITONE (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
70199-017-0170199001701100 TABLET in 1 BOTTLE (70199-017-01) 100 tablet2019-11-270000-00-00NoNoCurrent
70199-017-307019900173030 TABLET in 1 BOTTLE (70199-017-30) 30 tablet2019-11-270000-00-00NoNoCurrent