FDA.reportPublic FDA data

Chlorthalidone

Product NDC
51079-058
11-digit product format
510790058
Labeler code
51079
Product ID
51079-058_48d2cfb7-9e20-e6da-e063-6294a90a9254
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
chlorthalidone
Dosage form
TABLET
Route
ORAL
Labeler
Mylan Institutional Inc.
Application
ANDA086831
Marketing category
ANDA
Marketing start
1998-06-12
Substance
CHLORTHALIDONE
Active strength
25 mg/1
Pharmacologic classes
Increased Diuresis [PE], Thiazide-like Diuretic [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Chlorthalidone
Listing expiration
2027-12-31

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
51079-058-01Chlorthalidone1 in 1 BLISTER PACKTABLET18
51079-058-20Chlorthalidone100 in 1 CARTONTABLET1008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51079-058-01EA - Each51079-0580717148a-35e4-46bf-ba3d-6d5d06cea46012012-07-24
51079-058-20EA - Each51079-058e9b50fd7-ca7c-49ba-b9ff-2e5125477a9312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CHLORTHALIDONEACTIVE INGREDIENTQ0MQD1073QCHLORTHALIDONE TABLET [MYLAN INSTITUTIONAL INC.]2
CHLORTHALIDONEACTIVE MOIETYQ0MQD1073QCHLORTHALIDONE TABLET [MYLAN INSTITUTIONAL INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCHLORTHALIDONE TABLET [MYLAN INSTITUTIONAL INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCHLORTHALIDONE TABLET [MYLAN INSTITUTIONAL INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CHLORTHALIDONE TABLET [MYLAN INSTITUTIONAL INC.]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2CHLORTHALIDONE TABLET [MYLAN INSTITUTIONAL INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCHLORTHALIDONE TABLET [MYLAN INSTITUTIONAL INC.]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APCHLORTHALIDONE TABLET [MYLAN INSTITUTIONAL INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51079-058CHLORTHALIDONE TABLET [MYLAN INSTITUTIONAL INC.]6Current NDC, Legacy NDC, 2 package rows20211223_193c85ba-43c2-4be2-82cf-7b394a83390e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197499chlorthalidone 25 MG Oral TabletPSN193c85ba-43c2-4be2-82cf-7b394a83390e8
197499chlorthalidone 25 MG Oral TabletSCD193c85ba-43c2-4be2-82cf-7b394a83390e8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51079-058-01510790058011 in 1 BLISTER PACKHistorical
51079-058-2051079005820100 BLISTER PACK in 1 CARTON (51079-058-20) / 1 TABLET in 1 BLISTER PACK (51079-058-01) 100 blister pack1998-06-120000-00-00NoNoCurrent