FDA.reportPublic FDA data

Chlorthalidone

Product NDC
57664-649
11-digit product format
576640649
Labeler code
57664
Product ID
57664-649_eca591c9-75f8-2cbb-e053-2a95a90a7cf4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Chlorthalidone
Dosage form
TABLET
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA089286
Marketing category
ANDA
Marketing start
2016-02-12
Substance
CHLORTHALIDONE
Active strength
50 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
CHLORTHALIDONE50 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
57664-649-18Chlorthalidone1000 in 1 BOTTLETABLET10006
57664-649-88Chlorthalidone100 in 1 BOTTLETABLET1006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57664-649-88EA - Each57664-6491cbb3086-9151-4999-a83c-d647a6d2783312016-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57664-649CHLORTHALIDONE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]6Current NDC, Legacy NDC, 2 package rows20221105_a304de67-cd2b-4933-937e-4eeecf6cda40.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197499chlorthalidone 25 MG Oral TabletPSN08b7ee65-53a5-ffbb-e063-6294a90ad4ee14
197500chlorthalidone 50 MG Oral TabletPSN08b7ee65-53a5-ffbb-e063-6294a90ad4ee14
197499chlorthalidone 25 MG Oral TabletSCD08b7ee65-53a5-ffbb-e063-6294a90ad4ee14
197500chlorthalidone 50 MG Oral TabletSCD08b7ee65-53a5-ffbb-e063-6294a90ad4ee14
197499chlorthalidone 25 MG Oral TabletPSNa304de67-cd2b-4933-937e-4eeecf6cda406
197500chlorthalidone 50 MG Oral TabletPSNa304de67-cd2b-4933-937e-4eeecf6cda406
197499chlorthalidone 25 MG Oral TabletSCDa304de67-cd2b-4933-937e-4eeecf6cda406
197500chlorthalidone 50 MG Oral TabletSCDa304de67-cd2b-4933-937e-4eeecf6cda406
197500chlorthalidone 50 MG Oral TabletPSN5c0e820b-90c3-47fb-8518-d53998f3c9f13
197500chlorthalidone 50 MG Oral TabletSCD5c0e820b-90c3-47fb-8518-d53998f3c9f13
197500chlorthalidone 50 MG Oral TabletPSN5ea42479-84f4-434d-b65b-de34a7a579261
197500chlorthalidone 50 MG Oral TabletSCD5ea42479-84f4-434d-b65b-de34a7a579261

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57664-649-18576640649181000 TABLET in 1 BOTTLE (57664-649-18) 1000 tablet2022-11-040000-00-00NoNoCurrent
57664-649-8857664064988100 TABLET in 1 BOTTLE (57664-649-88) 100 tablet2016-02-120000-00-00NoNoCurrent