FDA.reportPublic FDA data

CHLORTHALIDONE

Product NDC
70756-011
11-digit product format
707560011
Labeler code
70756
Product ID
70756-011_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
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
70756-011-11CHLORTHALIDONE100 in 1 BOTTLETABLET1004
70756-011-12CHLORTHALIDONE1000 in 1 BOTTLETABLET10004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70756-011-11EA - Each70756-01164ce5556-cbbe-4ecd-85b9-95248941fc0f12022-12-07
70756-011-12EA - Each70756-01133016203-31e5-4e0e-bfe2-fdae87376b4b12022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70756-011CHLORTHALIDONE 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 TabletPSNd867a784-54f0-4cce-9306-f92de095e855101
197499chlorthalidone 25 MG Oral TabletSCDd867a784-54f0-4cce-9306-f92de095e855101
197499chlorthalidone 25 MG Oral TabletPSN0baac2aa-06c4-489e-a3f9-fe9d20cf61a25
197499chlorthalidone 25 MG Oral TabletSCD0baac2aa-06c4-489e-a3f9-fe9d20cf61a25
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
197499chlorthalidone 25 MG Oral TabletPSNd07eea8b-361b-486a-a572-3bf4a257f4311
197499chlorthalidone 25 MG Oral TabletSCDd07eea8b-361b-486a-a572-3bf4a257f4311

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70756-011-1170756001111100 TABLET in 1 BOTTLE (70756-011-11) 100 tablet2022-08-050000-00-00NoNoCurrent
70756-011-12707560011121000 TABLET in 1 BOTTLE (70756-011-12) 1000 tablet2022-08-050000-00-00NoNoCurrent