FDA.reportPublic FDA data

CHLORTHALIDONE

Product NDC
43598-170
11-digit product format
435980170
Labeler code
43598
Product ID
43598-170_bd2e4486-0720-4d09-b4f5-472c4478af0e
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
2022-10-20
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
43598-170-01CHLORTHALIDONE100 in 1 BOTTLETABLET1001
43598-170-10CHLORTHALIDONE1000 in 1 BOTTLETABLET10001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-170-01EA - Each43598-170312d860d-eea6-49f7-b199-c1a0920da7d512023-01-09
43598-170-10EA - Each43598-170ba3379ef-a633-4767-84f3-363aad745bfd12023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-170CHLORTHALIDONE TABLET [DR. REDDY'S LABORATORIES INC.]1Current NDC, Legacy NDC, 2 package rows20221208_bd2e4486-0720-4d09-b4f5-472c4478af0e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197499chlorthalidone 25 MG Oral TabletPSNe3ff03fd-bbab-4c8d-b24d-40c611db3bb32
197499chlorthalidone 25 MG Oral TabletSCDe3ff03fd-bbab-4c8d-b24d-40c611db3bb32
197499chlorthalidone 25 MG Oral TabletPSNbd2e4486-0720-4d09-b4f5-472c4478af0e1
197500chlorthalidone 50 MG Oral TabletPSNbd2e4486-0720-4d09-b4f5-472c4478af0e1
197499chlorthalidone 25 MG Oral TabletSCDbd2e4486-0720-4d09-b4f5-472c4478af0e1
197500chlorthalidone 50 MG Oral TabletSCDbd2e4486-0720-4d09-b4f5-472c4478af0e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43598-170-0143598017001100 TABLET in 1 BOTTLE (43598-170-01) 100 tablet2022-10-200000-00-00NoNoCurrent
43598-170-10435980170101000 TABLET in 1 BOTTLE (43598-170-10) 1000 tablet2022-10-200000-00-00NoNoCurrent