FDA.reportPublic FDA data

Chlorthalidone

Product NDC
65162-247
11-digit product format
651620247
Labeler code
65162
Product ID
65162-247_6489aee4-4593-4cc5-97dc-24a7a2eaab67
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Chlorthalidone
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA207204
Marketing category
ANDA
Marketing start
2019-07-01
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
65162-247-03Chlorthalidone30 in 1 BOTTLETABLET3012
65162-247-09Chlorthalidone90 in 1 BOTTLETABLET9012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65162-247-09EA - Each65162-247d090a100-196b-41df-a995-ffa72bcee9b512019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-247CHLORTHALIDONE TABLET [AMNEAL PHARMACEUTICALS LLC]12Current NDC, Legacy NDC, 2 package rows20241210_c4c1bfe5-b5c8-43c0-9428-62337095b2bd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197499chlorthalidone 25 MG Oral TabletPSNc4c1bfe5-b5c8-43c0-9428-62337095b2bd12
197500chlorthalidone 50 MG Oral TabletPSNc4c1bfe5-b5c8-43c0-9428-62337095b2bd12
197499chlorthalidone 25 MG Oral TabletSCDc4c1bfe5-b5c8-43c0-9428-62337095b2bd12
197500chlorthalidone 50 MG Oral TabletSCDc4c1bfe5-b5c8-43c0-9428-62337095b2bd12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65162-247-036516202470330 TABLET in 1 BOTTLE (65162-247-03) 30 tablet2019-07-010000-00-00NoNoCurrent
65162-247-096516202470990 TABLET in 1 BOTTLE (65162-247-09) 90 tablet2019-07-010000-00-00NoNoCurrent