FDA.reportPublic FDA data

CHLORTHALIDONE

Product NDC
43598-720
11-digit product format
435980720
Labeler code
43598
Product ID
43598-720_46902081-6a2d-4489-b828-351a33d405b5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CHLORTHALIDONE
Dosage form
TABLET
Route
ORAL
Labeler
Dr. Reddy's Laboratories Inc.
Application
ANDA210742
Marketing category
ANDA
Marketing start
2018-10-23
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
43598-720-01CHLORTHALIDONE100 in 1 BOTTLETABLET1005
43598-720-10CHLORTHALIDONE1000 in 1 BOTTLETABLET10005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-720-01EA - Each43598-720551018a0-e47b-482d-b75f-d1baa654e6a112018-12-13
43598-720-10EA - Each43598-72090c3f1e8-9981-47c9-ae3a-a5ecaed881bd12022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-720CHLORTHALIDONE TABLET [DR. REDDY'S LABORATORIES INC.]5Current NDC, Legacy NDC, 2 package rows20220125_9e9e9ced-6960-4d2f-bb23-ef8b2435da75.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197499chlorthalidone 25 MG Oral TabletPSN9e9e9ced-6960-4d2f-bb23-ef8b2435da755
197500chlorthalidone 50 MG Oral TabletPSN9e9e9ced-6960-4d2f-bb23-ef8b2435da755
197499chlorthalidone 25 MG Oral TabletSCD9e9e9ced-6960-4d2f-bb23-ef8b2435da755
197500chlorthalidone 50 MG Oral TabletSCD9e9e9ced-6960-4d2f-bb23-ef8b2435da755
197500chlorthalidone 50 MG Oral TabletPSNf309b5df-ce39-0d55-e053-2995a90a78782
197500chlorthalidone 50 MG Oral TabletSCDf309b5df-ce39-0d55-e053-2995a90a78782

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43598-720-0143598072001100 TABLET in 1 BOTTLE (43598-720-01) 100 tablet2018-10-230000-00-00NoNoCurrent
43598-720-10435980720101000 TABLET in 1 BOTTLE (43598-720-10) 1000 tablet2021-12-090000-00-00NoNoCurrent