FDA.reportPublic FDA data

CHLORTHALIDONE

Product NDC
70756-020
11-digit product format
707560020
Labeler code
70756
Product ID
70756-020_2a4e8dca-dfb5-4baf-889e-9ae0237ef081
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
chlorthalidone
Dosage form
TABLET
Route
ORAL
Labeler
Lifestar Pharma LLC
Application
ANDA215587
Marketing category
ANDA
Marketing start
2022-08-05
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
70756-020-11CHLORTHALIDONE100 in 1 BOTTLETABLET1004
70756-020-12CHLORTHALIDONE1000 in 1 BOTTLETABLET10004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70756-020-11EA - Each70756-020e9def57b-6594-4982-93d1-b1efaf1e155e12022-12-07
70756-020-12EA - Each70756-020089eac27-ab5d-4c67-ab98-d73b36623da812022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70756-020CHLORTHALIDONE TABLET [LIFESTAR PHARMA LLC]4Current NDC, Legacy NDC, 2 package rows20250309_c8e2b475-a8e9-4aa9-b4e9-66d746bbdc70.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197499chlorthalidone 25 MG Oral TabletPSNc8e2b475-a8e9-4aa9-b4e9-66d746bbdc704
197500chlorthalidone 50 MG Oral TabletPSNc8e2b475-a8e9-4aa9-b4e9-66d746bbdc704
197499chlorthalidone 25 MG Oral TabletSCDc8e2b475-a8e9-4aa9-b4e9-66d746bbdc704
197500chlorthalidone 50 MG Oral TabletSCDc8e2b475-a8e9-4aa9-b4e9-66d746bbdc704
197500chlorthalidone 50 MG Oral TabletPSN3c76c7a6-abfb-4dc1-ad5a-d7d00cb832cb1
197500chlorthalidone 50 MG Oral TabletSCD3c76c7a6-abfb-4dc1-ad5a-d7d00cb832cb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70756-020-1170756002011100 TABLET in 1 BOTTLE (70756-020-11) 100 tablet2022-08-050000-00-00NoNoCurrent
70756-020-12707560020121000 TABLET in 1 BOTTLE (70756-020-12) 1000 tablet2022-08-050000-00-00NoNoCurrent