FDA.reportPublic FDA data

Terazosin

Product NDC
71610-503
11-digit product format
716100503
Labeler code
71610
Product ID
71610-503_b23a32b3-7e6b-4b58-be96-303ac3ef069a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Terazosin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA075317
Marketing category
ANDA
Marketing start
2020-03-30
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Terazosin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TERAZOSIN HYDROCHLORIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiD32S14F082
Rxcui313217, 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
71610-503-60Terazosin90 in 1 BOTTLECAPSULE901
71610-503-80Terazosin180 in 1 BOTTLECAPSULE1801

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-503-60EA - Each71610-50300f23167-3565-449b-8059-2bf1dce7324212021-03-02
71610-503-80EA - Each71610-503ae20a0df-1855-4ff3-8aa2-778cf34ab46912021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-503TERAZOSIN (TERAZOSIN HYDROCHLORIDE) CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Current NDC, Legacy NDC, 2 package rows20210124_81d5422c-ff57-4f6d-927c-5de4dd7e1169.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313217terazosin HCl 2 MG Oral CapsulePSN81d5422c-ff57-4f6d-927c-5de4dd7e11691
313219terazosin HCl 5 MG Oral CapsulePSN81d5422c-ff57-4f6d-927c-5de4dd7e11691
313217terazosin 2 MG Oral CapsuleSCD81d5422c-ff57-4f6d-927c-5de4dd7e11691
313219terazosin 5 MG Oral CapsuleSCD81d5422c-ff57-4f6d-927c-5de4dd7e11691
313217terazosin (as terazosin HCl) 2 MG Oral CapsuleSY81d5422c-ff57-4f6d-927c-5de4dd7e11691
313219terazosin (as terazosin hydrochloride) 5 MG Oral CapsuleSY81d5422c-ff57-4f6d-927c-5de4dd7e11691

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71610-503-607161005036090 CAPSULE in 1 BOTTLE (71610-503-60) 90 capsule2020-12-080000-00-00NoNoCurrent
71610-503-8071610050380180 CAPSULE in 1 BOTTLE (71610-503-80) 180 capsule2020-12-080000-00-00NoNoCurrent