FDA.reportPublic FDA data

Terazosin Hydrochloride

Product NDC
53808-0311
11-digit product format
538080311
Labeler code
53808
Product ID
53808-0311_9e1fb9de-7a5e-4878-af41-2efe32d8f9ad
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Terazosin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
State of Florida DOH Central Pharmacy
Application
ANDA075317
Marketing category
ANDA
Marketing start
2009-07-01
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
E
Listing certified through
2018-12-31
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
53808-0311-12020-01-31C16284748780-19d75b9d1-0ca5-f424-e053-dadaa90a57ceTERAZOSIN HYDROCHLORIDE CAPSULES

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53808-0311-1Terazosin Hydrochloride30 in 1 BLISTER PACKCAPSULE301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-0311TERAZOSIN HYDROCHLORIDE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1Legacy NDC, 1 package rows20100804_66abc5e3-4a7c-447a-8daa-91b872b88094.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313215terazosin HCl 1 MG Oral CapsulePSN66abc5e3-4a7c-447a-8daa-91b872b880941
313217terazosin HCl 2 MG Oral CapsulePSN66abc5e3-4a7c-447a-8daa-91b872b880941
313219terazosin HCl 5 MG Oral CapsulePSN66abc5e3-4a7c-447a-8daa-91b872b880941
313215terazosin 1 MG Oral CapsuleSCD66abc5e3-4a7c-447a-8daa-91b872b880941
313217terazosin 2 MG Oral CapsuleSCD66abc5e3-4a7c-447a-8daa-91b872b880941
313219terazosin 5 MG Oral CapsuleSCD66abc5e3-4a7c-447a-8daa-91b872b880941
313215terazosin (as terazosin HCl) 1 MG Oral CapsuleSY66abc5e3-4a7c-447a-8daa-91b872b880941
313217terazosin (as terazosin HCl) 2 MG Oral CapsuleSY66abc5e3-4a7c-447a-8daa-91b872b880941
313219terazosin (as terazosin hydrochloride) 5 MG Oral CapsuleSY66abc5e3-4a7c-447a-8daa-91b872b880941

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53808-0311-15380803110130 in 1 BLISTER PACKHistorical