Chlorthalidone

Product NDC
68382-970
11-digit product format
683820970
Labeler code
68382
Product ID
68382-970_1db5deb3-2699-4c73-a11e-1e4aa12e97fb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Chlorthalidone
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA207813
Marketing category
ANDA
Marketing start
2019-05-15
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
68382-970-01Chlorthalidone100 in 1 BOTTLETABLET1003
68382-970-10Chlorthalidone1000 in 1 BOTTLETABLET10003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-970CHLORTHALIDONE TABLET [ZYDUS PHARMACEUTICALS USA INC.]3Current NDC, Legacy NDC, 2 package rows20221007_ef8023a3-b2be-436e-9085-576781950665.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197499chlorthalidone 25 MG Oral TabletPSNef8023a3-b2be-436e-9085-5767819506653
197500chlorthalidone 50 MG Oral TabletPSNef8023a3-b2be-436e-9085-5767819506653
197499chlorthalidone 25 MG Oral TabletSCDef8023a3-b2be-436e-9085-5767819506653
197500chlorthalidone 50 MG Oral TabletSCDef8023a3-b2be-436e-9085-5767819506653

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68382-970-0168382097001100 TABLET in 1 BOTTLE (68382-970-01) 100 tablet2019-05-150000-00-00NoNoCurrent
68382-970-10683820970101000 TABLET in 1 BOTTLE (68382-970-10) 1000 tablet2019-05-150000-00-00NoNoCurrent