FDA.reportPublic FDA data

Chlorthalidone

Product NDC
57664-648
11-digit product format
576640648
Labeler code
57664
Product ID
57664-648_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
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
57664-648-18Chlorthalidone1000 in 1 BOTTLETABLET10006
57664-648-88Chlorthalidone100 in 1 BOTTLETABLET1006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57664-648-88EA - Each57664-648e9d5a627-da12-4d3a-8cae-5ffdcc00047f12016-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57664-648CHLORTHALIDONE 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 TabletPSNb1ff748d-36e9-4327-aa8a-e8fb22a9d6377
197499chlorthalidone 25 MG Oral TabletSCDb1ff748d-36e9-4327-aa8a-e8fb22a9d6377
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
197499chlorthalidone 25 MG Oral TabletPSN2de92cea-8f03-4af0-9d91-d4578510cc535
197499chlorthalidone 25 MG Oral TabletPSNee0a3be8-1035-49fa-8a5d-b08cf31a16225
197499chlorthalidone 25 MG Oral TabletSCD2de92cea-8f03-4af0-9d91-d4578510cc535
197499chlorthalidone 25 MG Oral TabletSCDee0a3be8-1035-49fa-8a5d-b08cf31a16225
197499chlorthalidone 25 MG Oral TabletPSNacdd4b78-0d80-4e61-b706-a58eef64d56c2
197499chlorthalidone 25 MG Oral TabletSCDacdd4b78-0d80-4e61-b706-a58eef64d56c2
197499chlorthalidone 25 MG Oral TabletPSN6e5cc0d8-6575-4675-bd8b-9a21b206aae11
197499chlorthalidone 25 MG Oral TabletSCD6e5cc0d8-6575-4675-bd8b-9a21b206aae11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57664-648-18576640648181000 TABLET in 1 BOTTLE (57664-648-18) 1000 tablet2022-11-040000-00-00NoNoCurrent
57664-648-8857664064888100 TABLET in 1 BOTTLE (57664-648-88) 100 tablet2016-02-120000-00-00NoNoCurrent