CHLORTHALIDONE

Product NDC
53002-1623
11-digit product format
530021623
Labeler code
53002
Product ID
53002-1623_449028a8-d660-4e80-8498-c0778f87d513
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CHLORTHALIDONE
Dosage form
TABLET
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA206904
Marketing category
ANDA
Marketing start
2017-05-17
Marketing end
0000-00-00
Substance
CHLORTHALIDONE
Active strength
25 mg/1
Pharmacologic classes
Thiazide-like Diuretic [EPC],Increased Diuresis [PE]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-1623-0CHLORTHALIDONE100 in 1 BOTTLETABLET1005
53002-1623-3CHLORTHALIDONE30 in 1 BOTTLETABLET305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-1623CHLORTHALIDONE TABLET [RPK PHARMACEUTICALS, INC.]5Legacy NDC, 2 package rows20230609_9b5c2ff4-d427-4f37-826a-7bac6abad735.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197499chlorthalidone 25 MG Oral TabletPSN9b5c2ff4-d427-4f37-826a-7bac6abad7355
197499chlorthalidone 25 MG Oral TabletSCD9b5c2ff4-d427-4f37-826a-7bac6abad7355

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-1623-053002162300100 TABLET in 1 BOTTLE (53002-1623-0) 100 tablet2017-09-010000-00-00NoNoCurrent
53002-1623-35300216230330 TABLET in 1 BOTTLE (53002-1623-3) 30 tablet2017-09-010000-00-00NoNoCurrent