FDA.reportPublic FDA data

Terazosin

Product NDC
53002-1727
11-digit product format
530021727
Labeler code
53002
Product ID
53002-1727_3a583e1c-ea90-4b86-871e-b9ff5291b5db
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Terazosin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA075317
Marketing category
ANDA
Marketing start
2004-12-20
Marketing end
0000-00-00
Substance
TERAZOSIN HYDROCHLORIDE
Active strength
5 mg/1
Pharmacologic classes
Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53002-1727-02025-01-30C16284748780-19d75b9d0-3847-f424-e053-dadaa90a57ceTERAZOSIN CAPSULES, USP
53002-1727-32025-01-30C16284748780-19d75b9d0-3847-f424-e053-dadaa90a57ceTERAZOSIN CAPSULES, USP
53002-1727-02023-06-07C16284748780-19d75b9d0-3847-f424-e053-dadaa90a57ceTERAZOSIN CAPSULES, USP
53002-1727-32023-06-07C16284748780-19d75b9d0-3847-f424-e053-dadaa90a57ceTERAZOSIN CAPSULES, USP
53002-1727-02023-01-30C16284748780-19d75b9d0-3847-f424-e053-dadaa90a57ceTERAZOSIN CAPSULES, USP
53002-1727-32023-01-30C16284748780-19d75b9d0-3847-f424-e053-dadaa90a57ceTERAZOSIN CAPSULES, USP
53002-1727-02020-12-15C16284748780-19d75b9d0-3847-f424-e053-dadaa90a57ceTERAZOSIN CAPSULES, USP
53002-1727-32020-12-15C16284748780-19d75b9d0-3847-f424-e053-dadaa90a57ceTERAZOSIN CAPSULES, USP
53002-1727-02020-01-31C16284748780-19d75b9d0-3847-f424-e053-dadaa90a57ceTERAZOSIN CAPSULES, USP
53002-1727-32020-01-31C16284748780-19d75b9d0-3847-f424-e053-dadaa90a57ceTERAZOSIN CAPSULES, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-1727-0Terazosin100 in 1 BOTTLECAPSULE10010
53002-1727-3Terazosin30 in 1 BOTTLECAPSULE3010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-1727TERAZOSIN (TERAZOSIN HYDROCHLORIDE) CAPSULE [RPK PHARMACEUTICALS, INC.]10Legacy NDC, 2 package rows20230609_ec962052-7bea-4aeb-ac49-0072fdc77385.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-1727-053002172700100 CAPSULE in 1 BOTTLE (53002-1727-0) 100 capsule2018-10-010000-00-00NoNoCurrent
53002-1727-35300217270330 CAPSULE in 1 BOTTLE (53002-1727-3) 30 capsule2018-10-010000-00-00NoNoCurrent