Hydrochlorothiazide

Product NDC
51079-776
11-digit product format
510790776
Labeler code
51079
Product ID
51079-776_a59f8988-f146-7db2-e053-2995a90aa70f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hydrochlorothiazide
Dosage form
CAPSULE
Route
ORAL
Labeler
Mylan Institutional Inc.
Application
ANDA075640
Marketing category
ANDA
Marketing start
2005-11-01
Marketing end
2021-06-30
Substance
HYDROCHLOROTHIAZIDE
Active strength
13 mg/1
Pharmacologic classes
Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct51079-776DDiscontinued by firm2026-07-31
excluded packagepackage51079-77651079-776-20DDiscontinued by firm2026-07-31

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075640-001HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORAL2000-01-28

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51079-776-01EA - Each51079-7764a3bd6d0-1261-47f4-b048-9837889c334212012-07-24
51079-776-20EA - Each51079-77624cecdf7-0352-4c90-9f4f-19f65796d0dc12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THHYDROCHLOROTHIAZIDE CAPSULE [CARDINAL HEALTH]5
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THHYDROCHLOROTHIAZIDE CAPSULE [CARDINAL HEALTH]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDROCHLOROTHIAZIDE CAPSULE [CARDINAL HEALTH]5
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GHYDROCHLOROTHIAZIDE CAPSULE [CARDINAL HEALTH]5
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDHYDROCHLOROTHIAZIDE CAPSULE [CARDINAL HEALTH]5
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKHYDROCHLOROTHIAZIDE CAPSULE [CARDINAL HEALTH]5
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAHYDROCHLOROTHIAZIDE CAPSULE [CARDINAL HEALTH]5
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357HYDROCHLOROTHIAZIDE CAPSULE [CARDINAL HEALTH]5
GELATININACTIVE INGREDIENT2G86QN327LHYDROCHLOROTHIAZIDE CAPSULE [CARDINAL HEALTH]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROCHLOROTHIAZIDE CAPSULE [CARDINAL HEALTH]5
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3HYDROCHLOROTHIAZIDE CAPSULE [CARDINAL HEALTH]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYDROCHLOROTHIAZIDE CAPSULE [CARDINAL HEALTH]5
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JHYDROCHLOROTHIAZIDE CAPSULE [CARDINAL HEALTH]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHYDROCHLOROTHIAZIDE CAPSULE [CARDINAL HEALTH]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHYDROCHLOROTHIAZIDE CAPSULE [CARDINAL HEALTH]5
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THHYDROCHLOROTHIAZIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THHYDROCHLOROTHIAZIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDROCHLOROTHIAZIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GHYDROCHLOROTHIAZIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDHYDROCHLOROTHIAZIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKHYDROCHLOROTHIAZIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAHYDROCHLOROTHIAZIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357HYDROCHLOROTHIAZIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
GELATININACTIVE INGREDIENT2G86QN327LHYDROCHLOROTHIAZIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROCHLOROTHIAZIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3HYDROCHLOROTHIAZIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
SHELLACINACTIVE INGREDIENT46N107B71OHYDROCHLOROTHIAZIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYDROCHLOROTHIAZIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JHYDROCHLOROTHIAZIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHYDROCHLOROTHIAZIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHYDROCHLOROTHIAZIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51079-776-2051079077620100 BLISTER PACK in 1 CARTON (51079-776-20) > 1 CAPSULE in 1 BLISTER PACK (51079-776-01) 100 blister pack2005-11-012021-06-30NoNoCurrent