FDA.reportPublic FDA data

Chlorthalidone

Product NDC
50090-6126
11-digit product format
500906126
Labeler code
50090
Product ID
50090-6126_06e4d0c5-a04c-42e0-aa03-3b072e679761
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Chlorthalidone
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA213412
Marketing category
ANDA
Marketing start
2020-02-13
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-6126-1Chlorthalidone30 in 1 BOTTLETABLET303
50090-6126-2Chlorthalidone90 in 1 BOTTLETABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6126-1EA - Each50090-6126eeedef0f-20c4-4ec8-9a29-63dd226850c712022-11-07
50090-6126-2EA - Each50090-6126dd6f8dd4-591a-4b08-bc6d-da44f806ee8c12022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6126CHLORTHALIDONE TABLET [A-S MEDICATION SOLUTIONS]3Current NDC, Legacy NDC, 2 package rows20231017_c5796482-ad1f-437a-ae80-c288880f4100.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197499chlorthalidone 25 MG Oral TabletPSNc5796482-ad1f-437a-ae80-c288880f41003
197499chlorthalidone 25 MG Oral TabletSCDc5796482-ad1f-437a-ae80-c288880f41003

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-6126-15009061260130 TABLET in 1 BOTTLE (50090-6126-1) 30 tablet2022-09-300000-00-00NoNoCurrent
50090-6126-25009061260290 TABLET in 1 BOTTLE (50090-6126-2) 90 tablet2022-09-300000-00-00NoNoCurrent