FDA.reportPublic FDA data

Chlorthalidone

Product NDC
75834-109
11-digit product format
758340109
Labeler code
75834
Product ID
75834-109_4581106c-4e01-7df9-e063-6294a90ac29f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Chlorthalidone
Dosage form
TABLET
Route
ORAL
Labeler
Nivagen Pharmaceuticals, INC.
Application
ANDA207222
Marketing category
ANDA
Marketing start
2018-05-28
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
75834-109-01Chlorthalidone100 in 1 BOTTLETABLET10015
75834-109-10Chlorthalidone1000 in 1 BOTTLETABLET100015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
75834-109-01EA - Each75834-10973a33fff-34ac-458d-ae1a-9fa09b0ded9c12018-07-03
75834-109-10EA - Each75834-109c951be59-ccab-42b4-b72f-1a89b4b784b112018-07-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75834-109CHLORTHALIDONE TABLET [NIVAGEN PHARMACEUTICALS, INC.]14Current NDC, Legacy NDC, 2 package rows20241225_36ef8d83-45f2-4873-b7cb-1be096d14d18.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197499chlorthalidone 25 MG Oral TabletPSN36ef8d83-45f2-4873-b7cb-1be096d14d1815
197500chlorthalidone 50 MG Oral TabletPSN36ef8d83-45f2-4873-b7cb-1be096d14d1815
197499chlorthalidone 25 MG Oral TabletSCD36ef8d83-45f2-4873-b7cb-1be096d14d1815
197500chlorthalidone 50 MG Oral TabletSCD36ef8d83-45f2-4873-b7cb-1be096d14d1815
197499chlorthalidone 25 MG Oral TabletPSNda829c8c-ae13-510b-e053-2995a90a70b84
197499chlorthalidone 25 MG Oral TabletSCDda829c8c-ae13-510b-e053-2995a90a70b84
197499chlorthalidone 25 MG Oral TabletPSN01337f79-4b3d-4749-a82b-8d56c1aec1792
197499chlorthalidone 25 MG Oral TabletSCD01337f79-4b3d-4749-a82b-8d56c1aec1792

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
75834-109-0175834010901100 TABLET in 1 BOTTLE (75834-109-01) 100 tablet2018-05-280000-00-00NoNoCurrent
75834-109-10758340109101000 TABLET in 1 BOTTLE (75834-109-10) 1000 tablet2018-05-280000-00-00NoNoCurrent