FDA.reportPublic FDA data

Terazosin

Product NDC
59746-383
11-digit product format
597460383
Labeler code
59746
Product ID
59746-383_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
1 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 HYDROCHLORIDE1 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
59746-383-06Terazosin100 in 1 BOTTLECAPSULE1008
59746-383-09Terazosin500 in 1 BOTTLECAPSULE5008
59746-383-10Terazosin1000 in 1 BOTTLECAPSULE10008
59746-383-90Terazosin90 in 1 BOTTLECAPSULE908

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59746-383TERAZOSIN (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
313215terazosin HCl 1 MG Oral CapsulePSN2c42171e-1b44-4d34-b6ca-5b6a94f0e6941014
313215terazosin 1 MG Oral CapsuleSCD2c42171e-1b44-4d34-b6ca-5b6a94f0e6941014
313215terazosin (as terazosin HCl) 1 MG Oral CapsuleSY2c42171e-1b44-4d34-b6ca-5b6a94f0e6941014
313215terazosin HCl 1 MG Oral CapsulePSN4b195327-10d4-477f-ada2-d62c7f835e6c14
313215terazosin HCl 1 MG Oral CapsulePSN242589f0-0c79-4ea1-b900-10bccfec2b8214
313215terazosin 1 MG Oral CapsuleSCD242589f0-0c79-4ea1-b900-10bccfec2b8214
313215terazosin 1 MG Oral CapsuleSCD4b195327-10d4-477f-ada2-d62c7f835e6c14
313215terazosin (as terazosin HCl) 1 MG Oral CapsuleSY4b195327-10d4-477f-ada2-d62c7f835e6c14
313215terazosin (as terazosin HCl) 1 MG Oral CapsuleSY242589f0-0c79-4ea1-b900-10bccfec2b8214
313215terazosin HCl 1 MG Oral CapsulePSN9d8fd052-b478-447e-a884-74fcd21275bb10
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 CapsulePSN9d8fd052-b478-447e-a884-74fcd21275bb10
313217terazosin HCl 2 MG Oral CapsulePSNec962052-7bea-4aeb-ac49-0072fdc7738510
313219terazosin HCl 5 MG Oral CapsulePSN9d8fd052-b478-447e-a884-74fcd21275bb10
313219terazosin HCl 5 MG Oral CapsulePSNec962052-7bea-4aeb-ac49-0072fdc7738510
313215terazosin 1 MG Oral CapsuleSCD9d8fd052-b478-447e-a884-74fcd21275bb10
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
313217terazosin 2 MG Oral CapsuleSCD9d8fd052-b478-447e-a884-74fcd21275bb10
313219terazosin 5 MG Oral CapsuleSCDec962052-7bea-4aeb-ac49-0072fdc7738510
313219terazosin 5 MG Oral CapsuleSCD9d8fd052-b478-447e-a884-74fcd21275bb10
313215terazosin (as terazosin HCl) 1 MG Oral CapsuleSYec962052-7bea-4aeb-ac49-0072fdc7738510
313215terazosin (as terazosin HCl) 1 MG Oral CapsuleSY9d8fd052-b478-447e-a884-74fcd21275bb10
260376terazosin (as terazosin HCl) 10 MG Oral CapsuleSYec962052-7bea-4aeb-ac49-0072fdc7738510
313217terazosin (as terazosin HCl) 2 MG Oral CapsuleSY9d8fd052-b478-447e-a884-74fcd21275bb10
313217terazosin (as terazosin HCl) 2 MG Oral CapsuleSYec962052-7bea-4aeb-ac49-0072fdc7738510
313219terazosin (as terazosin hydrochloride) 5 MG Oral CapsuleSY9d8fd052-b478-447e-a884-74fcd21275bb10
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 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 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 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 CapsulePSN4fa716c7-d6ef-2217-e054-00144ff8d46c3
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 CapsuleSCD4fa716c7-d6ef-2217-e054-00144ff8d46c3
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
313215terazosin (as terazosin HCl) 1 MG Oral CapsuleSY21c6bec7-4767-4113-8561-38497dae50d03
313215terazosin (as terazosin HCl) 1 MG Oral CapsuleSY4fa716c7-d6ef-2217-e054-00144ff8d46c3
260376terazosin (as terazosin HCl) 10 MG Oral CapsuleSY21c6bec7-4767-4113-8561-38497dae50d03
313217terazosin (as terazosin HCl) 2 MG Oral CapsuleSY21c6bec7-4767-4113-8561-38497dae50d03

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59746-383-0659746038306100 CAPSULE in 1 BOTTLE (59746-383-06) 100 capsule2004-12-200000-00-00NoNoCurrent
59746-383-0959746038309500 CAPSULE in 1 BOTTLE (59746-383-09) 500 capsule2004-12-200000-00-00NoNoCurrent
59746-383-10597460383101000 CAPSULE in 1 BOTTLE (59746-383-10) 1000 capsule2004-12-200000-00-00NoNoCurrent
59746-383-905974603839090 CAPSULE in 1 BOTTLE (59746-383-90) 90 capsule2004-12-200000-00-00NoNoCurrent