FDA.reportPublic FDA data

CHLORTHALIDONE

Product NDC
71335-3124
11-digit product format
713353124
Labeler code
71335
Product ID
71335-3124_90b2f1b0-82e6-4313-b9dc-6b2036945c36
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Chlorthalidone
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA211320
Marketing category
ANDA
Marketing start
2024-10-23
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
71335-3124-1CHLORTHALIDONE30 in 1 BOTTLETABLET301
71335-3124-2CHLORTHALIDONE90 in 1 BOTTLETABLET901
71335-3124-3CHLORTHALIDONE60 in 1 BOTTLETABLET601
71335-3124-4CHLORTHALIDONE8 in 1 BOTTLETABLET81
71335-3124-5CHLORTHALIDONE100 in 1 BOTTLETABLET1001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197499chlorthalidone 25 MG Oral TabletPSNf46fd743-3661-41b7-b12d-30d96692f0ee1
197499chlorthalidone 25 MG Oral TabletSCDf46fd743-3661-41b7-b12d-30d96692f0ee1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-3124-17133531240130 TABLET in 1 BOTTLE (71335-3124-1) 30 tablet2026-04-20NoNoHistorical
71335-3124-27133531240290 TABLET in 1 BOTTLE (71335-3124-2) 90 tablet2026-04-20NoNoHistorical
71335-3124-37133531240360 TABLET in 1 BOTTLE (71335-3124-3) 60 tablet2026-04-20NoNoHistorical
71335-3124-4713353124048 TABLET in 1 BOTTLE (71335-3124-4) 8 tablet2026-04-20NoNoHistorical
71335-3124-571335312405100 TABLET in 1 BOTTLE (71335-3124-5) 100 tablet2026-04-20NoNoHistorical