FDA.reportPublic FDA data

Terazosin

Product NDC
59746-386
11-digit product format
597460386
Labeler code
59746
Product ID
59746-386_cc58b113-b1c4-4147-a20b-473c30aa7041
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Terazosin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Jubilant Cadista Pharmaceuticals Inc.
Application
ANDA075317
Marketing category
ANDA
Marketing start
2004-12-20
Substance
TERAZOSIN HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TERAZOSIN HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiD32S14F082
Rxcui260376, 313215, 313217, 313219

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
975cd6e7-95ee-60f8-7c38-135ffbb09240Product name220260223
1bc6d1ac-ef0f-4fc6-8704-c443f03b274aProduct name120250311
8adc9826-3fee-6091-f1ee-af9fd6f9caf8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59746-386-06Terazosin100 in 1 BOTTLECAPSULE1008
59746-386-09Terazosin500 in 1 BOTTLECAPSULE5008
59746-386-10Terazosin1000 in 1 BOTTLECAPSULE10008
59746-386-90Terazosin90 in 1 BOTTLECAPSULE908

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59746-386-06EA - Each59746-386a95641be-d090-4277-8d64-4c187784c66512012-07-24
59746-386-09EA - Each59746-3863cd54982-a247-4c7e-bcc7-a9ecbeea158c12012-07-24
59746-386-10EA - Each59746-386992cc5ae-db3c-4a04-9928-53bced543e5612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TERAZOSIN HYDROCHLORIDEACTIVE INGREDIENTD32S14F082TERAZOSIN (TERAZOSIN HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]1000
TERAZOSINACTIVE MOIETY8L5014XET7TERAZOSIN (TERAZOSIN HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]1000
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GTERAZOSIN (TERAZOSIN HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]1000
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1STERAZOSIN (TERAZOSIN HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]1000
GELATININACTIVE INGREDIENT2G86QN327LTERAZOSIN (TERAZOSIN HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]1000
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTERAZOSIN (TERAZOSIN HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]1000
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TERAZOSIN (TERAZOSIN HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]1000
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TERAZOSIN (TERAZOSIN HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]1000
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JTERAZOSIN (TERAZOSIN HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]1000
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTERAZOSIN (TERAZOSIN HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]1000
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTERAZOSIN (TERAZOSIN HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]1000
Terazosin HydrochlorideACTIVE INGREDIENTD32S14F082TERAZOSIN (TERAZOSIN HYDROCHLORIDE) CAPSULE [JUBILANT CADISTA PHARMACEUTICALS INC.]3
TerazosinACTIVE MOIETY8L5014XET7TERAZOSIN (TERAZOSIN HYDROCHLORIDE) CAPSULE [JUBILANT CADISTA PHARMACEUTICALS INC.]3
D&c Red No. 28INACTIVE INGREDIENT767IP0Y5NHTERAZOSIN (TERAZOSIN HYDROCHLORIDE) CAPSULE [JUBILANT CADISTA PHARMACEUTICALS INC.]3
D&c Yellow No. 10INACTIVE INGREDIENT35SW5USQ3GTERAZOSIN (TERAZOSIN HYDROCHLORIDE) CAPSULE [JUBILANT CADISTA PHARMACEUTICALS INC.]3
Fd&c Green No. 3INACTIVE INGREDIENT3P3ONR6O1STERAZOSIN (TERAZOSIN HYDROCHLORIDE) CAPSULE [JUBILANT CADISTA PHARMACEUTICALS INC.]3
Fd&c Red No. 40INACTIVE INGREDIENTWZB9127XOATERAZOSIN (TERAZOSIN HYDROCHLORIDE) CAPSULE [JUBILANT CADISTA PHARMACEUTICALS INC.]3
Ferrosoferric OxideINACTIVE INGREDIENTXM0M87F357TERAZOSIN (TERAZOSIN HYDROCHLORIDE) CAPSULE [JUBILANT CADISTA PHARMACEUTICALS INC.]3
GelatinINACTIVE INGREDIENT2G86QN327LTERAZOSIN (TERAZOSIN HYDROCHLORIDE) CAPSULE [JUBILANT CADISTA PHARMACEUTICALS INC.]3
Lactose MonohydrateINACTIVE INGREDIENTEWQ57Q8I5XTERAZOSIN (TERAZOSIN HYDROCHLORIDE) CAPSULE [JUBILANT CADISTA PHARMACEUTICALS INC.]3
Magnesium StearateINACTIVE INGREDIENT70097M6I30TERAZOSIN (TERAZOSIN HYDROCHLORIDE) CAPSULE [JUBILANT CADISTA PHARMACEUTICALS INC.]3
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4TERAZOSIN (TERAZOSIN HYDROCHLORIDE) CAPSULE [JUBILANT CADISTA PHARMACEUTICALS INC.]3
Sodium Lauryl SulfateINACTIVE INGREDIENT368GB5141JTERAZOSIN (TERAZOSIN HYDROCHLORIDE) CAPSULE [JUBILANT CADISTA PHARMACEUTICALS INC.]3
Starch, CornINACTIVE INGREDIENTO8232NY3SJTERAZOSIN (TERAZOSIN HYDROCHLORIDE) CAPSULE [JUBILANT CADISTA PHARMACEUTICALS INC.]3
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JPTERAZOSIN (TERAZOSIN HYDROCHLORIDE) CAPSULE [JUBILANT CADISTA PHARMACEUTICALS INC.]3
Terazosin HydrochlorideACTIVE INGREDIENTD32S14F082TERAZOSIN HYDROCHLORIDE (TERAZOSIN HYDROCHLORIDE) CAPSULE TERAZOSIN HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
TerazosinACTIVE MOIETY8L5014XET7TERAZOSIN HYDROCHLORIDE (TERAZOSIN HYDROCHLORIDE) CAPSULE TERAZOSIN HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
D&c Red No. 28INACTIVE INGREDIENT767IP0Y5NHTERAZOSIN HYDROCHLORIDE (TERAZOSIN HYDROCHLORIDE) CAPSULE TERAZOSIN HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
D&c Yellow No. 10INACTIVE INGREDIENT35SW5USQ3GTERAZOSIN HYDROCHLORIDE (TERAZOSIN HYDROCHLORIDE) CAPSULE TERAZOSIN HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
Fd&c Green No. 3INACTIVE INGREDIENT3P3ONR6O1STERAZOSIN HYDROCHLORIDE (TERAZOSIN HYDROCHLORIDE) CAPSULE TERAZOSIN HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
Fd&c Red No. 40INACTIVE INGREDIENTWZB9127XOATERAZOSIN HYDROCHLORIDE (TERAZOSIN HYDROCHLORIDE) CAPSULE TERAZOSIN HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
Ferrosoferric OxideINACTIVE INGREDIENTXM0M87F357TERAZOSIN HYDROCHLORIDE (TERAZOSIN HYDROCHLORIDE) CAPSULE TERAZOSIN HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
GelatinINACTIVE INGREDIENT2G86QN327LTERAZOSIN HYDROCHLORIDE (TERAZOSIN HYDROCHLORIDE) CAPSULE TERAZOSIN HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
Lactose MonohydrateINACTIVE INGREDIENTEWQ57Q8I5XTERAZOSIN HYDROCHLORIDE (TERAZOSIN HYDROCHLORIDE) CAPSULE TERAZOSIN HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
Magnesium StearateINACTIVE INGREDIENT70097M6I30TERAZOSIN HYDROCHLORIDE (TERAZOSIN HYDROCHLORIDE) CAPSULE TERAZOSIN HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4TERAZOSIN HYDROCHLORIDE (TERAZOSIN HYDROCHLORIDE) CAPSULE TERAZOSIN HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
Sodium Lauryl SulfateINACTIVE INGREDIENT368GB5141JTERAZOSIN HYDROCHLORIDE (TERAZOSIN HYDROCHLORIDE) CAPSULE TERAZOSIN HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
Starch, CornINACTIVE INGREDIENTO8232NY3SJTERAZOSIN HYDROCHLORIDE (TERAZOSIN HYDROCHLORIDE) CAPSULE TERAZOSIN HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JPTERAZOSIN HYDROCHLORIDE (TERAZOSIN HYDROCHLORIDE) CAPSULE TERAZOSIN HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59746-386TERAZOSIN (TERAZOSIN HYDROCHLORIDE) CAPSULE [JUBILANT CADISTA PHARMACEUTICALS INC.]6Current NDC, Legacy NDC, 4 package rows20180502_43e92495-2cf2-46dd-a80c-f0c3c88c7b73.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
260376terazosin HCl 10 MG Oral CapsulePSN521e4aad-c6ec-4410-867f-dd9ecc08d5b21012
313217terazosin HCl 2 MG Oral CapsulePSN521e4aad-c6ec-4410-867f-dd9ecc08d5b21012
260376terazosin 10 MG Oral CapsuleSCD521e4aad-c6ec-4410-867f-dd9ecc08d5b21012
313217terazosin 2 MG Oral CapsuleSCD521e4aad-c6ec-4410-867f-dd9ecc08d5b21012
260376terazosin (as terazosin HCl) 10 MG Oral CapsuleSY521e4aad-c6ec-4410-867f-dd9ecc08d5b21012
313217terazosin (as terazosin HCl) 2 MG Oral CapsuleSY521e4aad-c6ec-4410-867f-dd9ecc08d5b21012
260376terazosin HCl 10 MG Oral CapsulePSN458b4a60-b2d6-445a-8638-7fcd07decf66103
260376terazosin HCl 10 MG Oral CapsulePSN33699a94-4561-455f-9e5d-48856369aa07103
260376terazosin 10 MG Oral CapsuleSCD33699a94-4561-455f-9e5d-48856369aa07103
260376terazosin 10 MG Oral CapsuleSCD458b4a60-b2d6-445a-8638-7fcd07decf66103
260376terazosin (as terazosin HCl) 10 MG Oral CapsuleSY458b4a60-b2d6-445a-8638-7fcd07decf66103
260376terazosin (as terazosin HCl) 10 MG Oral CapsuleSY33699a94-4561-455f-9e5d-48856369aa07103
260376terazosin HCl 10 MG Oral CapsulePSN83bf40fa-6ae1-4811-8dc1-e8c0bcd63d7831
313217terazosin HCl 2 MG Oral CapsulePSN83bf40fa-6ae1-4811-8dc1-e8c0bcd63d7831
313219terazosin HCl 5 MG Oral CapsulePSN83bf40fa-6ae1-4811-8dc1-e8c0bcd63d7831
260376terazosin 10 MG Oral CapsuleSCD83bf40fa-6ae1-4811-8dc1-e8c0bcd63d7831
313217terazosin 2 MG Oral CapsuleSCD83bf40fa-6ae1-4811-8dc1-e8c0bcd63d7831
313219terazosin 5 MG Oral CapsuleSCD83bf40fa-6ae1-4811-8dc1-e8c0bcd63d7831
260376terazosin (as terazosin HCl) 10 MG Oral CapsuleSY83bf40fa-6ae1-4811-8dc1-e8c0bcd63d7831
313217terazosin (as terazosin HCl) 2 MG Oral CapsuleSY83bf40fa-6ae1-4811-8dc1-e8c0bcd63d7831
313219terazosin (as terazosin hydrochloride) 5 MG Oral CapsuleSY83bf40fa-6ae1-4811-8dc1-e8c0bcd63d7831
313215terazosin HCl 1 MG Oral CapsulePSNec962052-7bea-4aeb-ac49-0072fdc7738510
260376terazosin HCl 10 MG Oral CapsulePSNec962052-7bea-4aeb-ac49-0072fdc7738510
313217terazosin HCl 2 MG Oral CapsulePSNec962052-7bea-4aeb-ac49-0072fdc7738510
313219terazosin HCl 5 MG Oral CapsulePSNec962052-7bea-4aeb-ac49-0072fdc7738510
313215terazosin 1 MG Oral CapsuleSCDec962052-7bea-4aeb-ac49-0072fdc7738510
260376terazosin 10 MG Oral CapsuleSCDec962052-7bea-4aeb-ac49-0072fdc7738510
313217terazosin 2 MG Oral CapsuleSCDec962052-7bea-4aeb-ac49-0072fdc7738510
313219terazosin 5 MG Oral CapsuleSCDec962052-7bea-4aeb-ac49-0072fdc7738510
313215terazosin (as terazosin HCl) 1 MG Oral CapsuleSYec962052-7bea-4aeb-ac49-0072fdc7738510
260376terazosin (as terazosin HCl) 10 MG Oral CapsuleSYec962052-7bea-4aeb-ac49-0072fdc7738510
313217terazosin (as terazosin HCl) 2 MG Oral CapsuleSYec962052-7bea-4aeb-ac49-0072fdc7738510
313219terazosin (as terazosin hydrochloride) 5 MG Oral CapsuleSYec962052-7bea-4aeb-ac49-0072fdc7738510
313215terazosin HCl 1 MG Oral CapsulePSN43e92495-2cf2-46dd-a80c-f0c3c88c7b738
260376terazosin HCl 10 MG Oral CapsulePSN43e92495-2cf2-46dd-a80c-f0c3c88c7b738
313217terazosin HCl 2 MG Oral CapsulePSN43e92495-2cf2-46dd-a80c-f0c3c88c7b738
313219terazosin HCl 5 MG Oral CapsulePSN43e92495-2cf2-46dd-a80c-f0c3c88c7b738
313215terazosin 1 MG Oral CapsuleSCD43e92495-2cf2-46dd-a80c-f0c3c88c7b738
260376terazosin 10 MG Oral CapsuleSCD43e92495-2cf2-46dd-a80c-f0c3c88c7b738
313217terazosin 2 MG Oral CapsuleSCD43e92495-2cf2-46dd-a80c-f0c3c88c7b738
313219terazosin 5 MG Oral CapsuleSCD43e92495-2cf2-46dd-a80c-f0c3c88c7b738
313215terazosin (as terazosin HCl) 1 MG Oral CapsuleSY43e92495-2cf2-46dd-a80c-f0c3c88c7b738
260376terazosin (as terazosin HCl) 10 MG Oral CapsuleSY43e92495-2cf2-46dd-a80c-f0c3c88c7b738
313217terazosin (as terazosin HCl) 2 MG Oral CapsuleSY43e92495-2cf2-46dd-a80c-f0c3c88c7b738
313219terazosin (as terazosin hydrochloride) 5 MG Oral CapsuleSY43e92495-2cf2-46dd-a80c-f0c3c88c7b738
313215terazosin HCl 1 MG Oral CapsulePSN9e7b27a6-cc09-407e-e053-2a95a90a17b35
260376terazosin HCl 10 MG Oral CapsulePSN9e7b27a6-cc09-407e-e053-2a95a90a17b35
313217terazosin HCl 2 MG Oral CapsulePSN9e7b27a6-cc09-407e-e053-2a95a90a17b35
313219terazosin HCl 5 MG Oral CapsulePSN9e7b27a6-cc09-407e-e053-2a95a90a17b35
313215terazosin 1 MG Oral CapsuleSCD9e7b27a6-cc09-407e-e053-2a95a90a17b35
260376terazosin 10 MG Oral CapsuleSCD9e7b27a6-cc09-407e-e053-2a95a90a17b35
313217terazosin 2 MG Oral CapsuleSCD9e7b27a6-cc09-407e-e053-2a95a90a17b35
313219terazosin 5 MG Oral CapsuleSCD9e7b27a6-cc09-407e-e053-2a95a90a17b35
313215terazosin (as terazosin HCl) 1 MG Oral CapsuleSY9e7b27a6-cc09-407e-e053-2a95a90a17b35
260376terazosin (as terazosin HCl) 10 MG Oral CapsuleSY9e7b27a6-cc09-407e-e053-2a95a90a17b35
313217terazosin (as terazosin HCl) 2 MG Oral CapsuleSY9e7b27a6-cc09-407e-e053-2a95a90a17b35
313219terazosin (as terazosin hydrochloride) 5 MG Oral CapsuleSY9e7b27a6-cc09-407e-e053-2a95a90a17b35
313215terazosin HCl 1 MG Oral CapsulePSNa2137488-8554-e84f-e053-2995a90a796c4
260376terazosin HCl 10 MG Oral CapsulePSN27f8952a-189d-4687-854e-c51da619bf3d4
260376terazosin HCl 10 MG Oral CapsulePSNa2137488-8554-e84f-e053-2995a90a796c4
313217terazosin HCl 2 MG Oral CapsulePSNa2137488-8554-e84f-e053-2995a90a796c4
313219terazosin HCl 5 MG Oral CapsulePSNa2137488-8554-e84f-e053-2995a90a796c4
313215terazosin 1 MG Oral CapsuleSCDa2137488-8554-e84f-e053-2995a90a796c4
260376terazosin 10 MG Oral CapsuleSCD27f8952a-189d-4687-854e-c51da619bf3d4
260376terazosin 10 MG Oral CapsuleSCDa2137488-8554-e84f-e053-2995a90a796c4
313217terazosin 2 MG Oral CapsuleSCDa2137488-8554-e84f-e053-2995a90a796c4
313219terazosin 5 MG Oral CapsuleSCDa2137488-8554-e84f-e053-2995a90a796c4
313215terazosin (as terazosin HCl) 1 MG Oral CapsuleSYa2137488-8554-e84f-e053-2995a90a796c4
260376terazosin (as terazosin HCl) 10 MG Oral CapsuleSY27f8952a-189d-4687-854e-c51da619bf3d4
260376terazosin (as terazosin HCl) 10 MG Oral CapsuleSYa2137488-8554-e84f-e053-2995a90a796c4
313217terazosin (as terazosin HCl) 2 MG Oral CapsuleSYa2137488-8554-e84f-e053-2995a90a796c4
313219terazosin (as terazosin hydrochloride) 5 MG Oral CapsuleSYa2137488-8554-e84f-e053-2995a90a796c4
313215terazosin HCl 1 MG Oral CapsulePSN21c6bec7-4767-4113-8561-38497dae50d03
260376terazosin HCl 10 MG Oral CapsulePSN21c6bec7-4767-4113-8561-38497dae50d03
313217terazosin HCl 2 MG Oral CapsulePSN21c6bec7-4767-4113-8561-38497dae50d03
313219terazosin HCl 5 MG Oral CapsulePSN21c6bec7-4767-4113-8561-38497dae50d03
313215terazosin 1 MG Oral CapsuleSCD21c6bec7-4767-4113-8561-38497dae50d03
260376terazosin 10 MG Oral CapsuleSCD21c6bec7-4767-4113-8561-38497dae50d03
313217terazosin 2 MG Oral CapsuleSCD21c6bec7-4767-4113-8561-38497dae50d03
313219terazosin 5 MG Oral CapsuleSCD21c6bec7-4767-4113-8561-38497dae50d03

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59746-386-0659746038606100 CAPSULE in 1 BOTTLE (59746-386-06) 100 capsule2004-12-200000-00-00NoNoCurrent
59746-386-0959746038609500 CAPSULE in 1 BOTTLE (59746-386-09) 500 capsule2004-12-200000-00-00NoNoCurrent
59746-386-10597460386101000 CAPSULE in 1 BOTTLE (59746-386-10) 1000 capsule2004-12-200000-00-00NoNoCurrent
59746-386-905974603869090 CAPSULE in 1 BOTTLE (59746-386-90) 90 capsule2006-12-200000-00-00NoNoCurrent