FDA.reportPublic FDA data

Chlorthalidone

Product NDC
50090-5643
11-digit product format
500905643
Labeler code
50090
Product ID
50090-5643_4a932f66-fffd-4432-b47e-c3d1f5ad55db
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Chlorthalidone
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA214129
Marketing category
ANDA
Marketing start
2021-05-20
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

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-5643-12023-02-06C16284748780-1f386c649-cb40-0266-e053-dadaa90a7c1aChlorthalidone Tablets, USP 25 mg and 50 mg Rx Only
50090-5643-22023-02-06C16284748780-1f386c649-cb40-0266-e053-dadaa90a7c1aChlorthalidone Tablets, USP 25 mg and 50 mg Rx Only
50090-5643-12023-01-30C16284748780-1f386c649-cb40-0266-e053-dadaa90a7c1aChlorthalidone Tablets, USP 25 mg and 50 mg Rx Only
50090-5643-22023-01-30C16284748780-1f386c649-cb40-0266-e053-dadaa90a7c1aChlorthalidone Tablets, USP 25 mg and 50 mg Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5643-1Chlorthalidone30 in 1 BOTTLETABLET306
50090-5643-2Chlorthalidone90 in 1 BOTTLETABLET906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5643-1EA - Each50090-5643e8f061ef-e51c-4098-addf-d3c77205b4c412022-10-06
50090-5643-2EA - Each50090-5643f854d63b-99b7-418a-ad8a-9df4977e3b4912022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5643CHLORTHALIDONE TABLET [A-S MEDICATION SOLUTIONS]6Current NDC, Legacy NDC, 2 package rows20230918_b3f053cd-7118-4602-9b15-7f7fd143b8c2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197499chlorthalidone 25 MG Oral TabletPSNb3f053cd-7118-4602-9b15-7f7fd143b8c26
197499chlorthalidone 25 MG Oral TabletSCDb3f053cd-7118-4602-9b15-7f7fd143b8c26

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5643-15009056430130 TABLET in 1 BOTTLE (50090-5643-1) 30 tablet2021-09-100000-00-00NoNoCurrent
50090-5643-25009056430290 TABLET in 1 BOTTLE (50090-5643-2) 90 tablet2021-09-100000-00-00NoNoCurrent