FDA.reportPublic FDA data

CHLORTHALIDONE

Product NDC
59746-760
11-digit product format
597460760
Labeler code
59746
Product ID
59746-760_51e6a425-96fd-4941-8c4d-4ba8c5dfb762
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Chlorthalidone
Dosage form
TABLET
Route
ORAL
Labeler
JUBILANT CADISTA PHARMACEUTICALS,INC.
Application
ANDA211320
Marketing category
ANDA
Marketing start
2021-03-31
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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLORTHALIDONE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQ0MQD1073Q
Rxcui197499, 197500

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
59746-760-01CHLORTHALIDONE100 in 1 BOTTLETABLET1002
59746-760-36CHLORTHALIDONE1000 in 1 BOTTLETABLET10002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59746-760-01EA - Each59746-760b351567d-af92-4e42-9eda-07a0e321ad1512022-11-07
59746-760-36EA - Each59746-760aa30630d-63ef-481a-b750-a0347bb3c1b212022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59746-760CHLORTHALIDONE TABLET [JUBILANT CADISTA PHARMACEUTICALS,INC.]2Current NDC, Legacy NDC, 2 package rows20221202_ca0df4ae-c424-44d2-8611-1637f1a101a8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197499chlorthalidone 25 MG Oral TabletPSN1ba595d4-b105-4d52-90dd-0fb8bda1fe1b100
197499chlorthalidone 25 MG Oral TabletSCD1ba595d4-b105-4d52-90dd-0fb8bda1fe1b100
197499chlorthalidone 25 MG Oral TabletPSNca0df4ae-c424-44d2-8611-1637f1a101a82
197500chlorthalidone 50 MG Oral TabletPSNca0df4ae-c424-44d2-8611-1637f1a101a82
197499chlorthalidone 25 MG Oral TabletSCDca0df4ae-c424-44d2-8611-1637f1a101a82
197500chlorthalidone 50 MG Oral TabletSCDca0df4ae-c424-44d2-8611-1637f1a101a82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59746-760-0159746076001100 TABLET in 1 BOTTLE (59746-760-01) 100 tablet2021-03-310000-00-00NoNoCurrent
59746-760-36597460760361000 TABLET in 1 BOTTLE (59746-760-36) 1000 tablet2021-03-310000-00-00NoNoCurrent