FDA.reportPublic FDA data

Chlorthalidone

Product NDC
21695-671
11-digit product format
216950671
Labeler code
21695
Product ID
21695-671_c10e3a16-d94f-442f-9303-4ded0adaecc1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
chlorthalidone
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA086831
Marketing category
ANDA
Marketing start
2009-11-18
Marketing end
0000-00-00
Substance
CHLORTHALIDONE
Active strength
25 mg/1
Pharmacologic classes
Thiazide-like Diuretic [EPC],Increased Diuresis [PE]
NDC exclude flag
E
Listing certified through
2017-12-31
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-671-302019-09-24C16284748780-1934fe258-499e-48b1-e053-8cdaa90a720aChlorthalidone

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-671-30Chlorthalidone30 in 1 BOTTLE, PLASTICTABLET301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-671-30EA - Each21695-6719baed88f-3c34-4d57-a510-8d6a2cf2b41d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CHLORTHALIDONEACTIVE INGREDIENTQ0MQD1073QCHLORTHALIDONE TABLET [REBEL DISTRIBUTORS CORP]1
CHLORTHALIDONEACTIVE MOIETYQ0MQD1073QCHLORTHALIDONE TABLET [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCHLORTHALIDONE TABLET [REBEL DISTRIBUTORS CORP]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCHLORTHALIDONE TABLET [REBEL DISTRIBUTORS CORP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CHLORTHALIDONE TABLET [REBEL DISTRIBUTORS CORP]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2CHLORTHALIDONE TABLET [REBEL DISTRIBUTORS CORP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCHLORTHALIDONE TABLET [REBEL DISTRIBUTORS CORP]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APCHLORTHALIDONE TABLET [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-671CHLORTHALIDONE TABLET [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20101220_c10e3a16-d94f-442f-9303-4ded0adaecc1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197499chlorthalidone 25 MG Oral TabletPSNc10e3a16-d94f-442f-9303-4ded0adaecc11
197499chlorthalidone 25 MG Oral TabletSCDc10e3a16-d94f-442f-9303-4ded0adaecc11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-671-302169506713030 in 1 BOTTLE, PLASTICHistorical