FDA.reportPublic FDA data

Chlorthalidone

Product NDC
68788-8294
11-digit product format
687888294
Labeler code
68788
Product ID
68788-8294_fcd89393-6075-4b43-aa32-54f34f74f578
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Chlorthalidone
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA214129
Marketing category
ANDA
Marketing start
2022-11-29
Substance
CHLORTHALIDONE
Active strength
25 mg/1
Pharmacologic classes
Increased Diuresis [PE], Thiazide-like Diuretic [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Chlorthalidone
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLORTHALIDONE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQ0MQD1073Q
Rxcui197499

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
68788-8294-3Chlorthalidone30 in 1 BOTTLETABLET305
68788-8294-9Chlorthalidone90 in 1 BOTTLETABLET905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8294-9EA - Each68788-8294a4c9e726-38c8-41ea-84d5-f1ee304e5c5812023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8294CHLORTHALIDONE TABLET [PREFERRED PHARMACEUTICALS INC.]4Current NDC, Legacy NDC, 2 package rows20250302_180cc3c7-6ab7-481b-b860-b20d3599e53f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197499chlorthalidone 25 MG Oral TabletPSN180cc3c7-6ab7-481b-b860-b20d3599e53f5
197499chlorthalidone 25 MG Oral TabletSCD180cc3c7-6ab7-481b-b860-b20d3599e53f5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-8294-36878882940330 TABLET in 1 BOTTLE (68788-8294-3) 30 tablet2023-04-20NoNoHistorical
68788-8294-96878882940990 TABLET in 1 BOTTLE (68788-8294-9) 90 tablet2022-11-290000-00-00NoNoCurrent