Chlorthalidone

Product NDC
68788-4053
11-digit product format
687884053
Labeler code
68788
Product ID
68788-4053_d61367af-530b-4e5e-8e71-11c93f75ecf1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Chlorthalidone
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA213412
Marketing category
ANDA
Marketing start
2025-11-17
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

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
68788-4053-3Chlorthalidone30 in 1 BOTTLETABLET301
68788-4053-9Chlorthalidone90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-4053-3EA - Each68788-40533a524084-821c-40db-a328-ebd0821aaa8b12026-03-17
68788-4053-9EA - Each68788-4053eff74b67-7e66-4911-a417-b45bb81deeec12026-03-17

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197499chlorthalidone 25 MG Oral TabletPSNd61367af-530b-4e5e-8e71-11c93f75ecf11
197499chlorthalidone 25 MG Oral TabletSCDd61367af-530b-4e5e-8e71-11c93f75ecf11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-4053-36878840530330 TABLET in 1 BOTTLE (68788-4053-3) 30 tablet2025-11-17NoNoCurrent
68788-4053-96878840530990 TABLET in 1 BOTTLE (68788-4053-9) 90 tablet2025-11-17NoNoCurrent