FDA.reportPublic FDA data

Terazosin

Product NDC
71335-3131
11-digit product format
713353131
Labeler code
71335
Product ID
71335-3131_12aa9f2d-da1f-43cf-a446-65c90c0503df
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Terazosin
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA075667
Marketing category
ANDA
Marketing start
2024-03-11
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
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 HYDROCHLORIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiD32S14F082
Rxcui313219

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
71335-3131-1Terazosin100 in 1 BOTTLECAPSULE1001
71335-3131-2Terazosin30 in 1 BOTTLECAPSULE301
71335-3131-3Terazosin90 in 1 BOTTLECAPSULE901
71335-3131-4Terazosin60 in 1 BOTTLECAPSULE601

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313219terazosin HCl 5 MG Oral CapsulePSNb77a4a38-edb1-412e-97af-d49e862b32c11
313219terazosin 5 MG Oral CapsuleSCDb77a4a38-edb1-412e-97af-d49e862b32c11
313219terazosin (as terazosin hydrochloride) 5 MG Oral CapsuleSYb77a4a38-edb1-412e-97af-d49e862b32c11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-3131-171335313101100 CAPSULE in 1 BOTTLE (71335-3131-1) 100 capsule2026-05-21NoNoHistorical
71335-3131-27133531310230 CAPSULE in 1 BOTTLE (71335-3131-2) 30 capsule2026-05-21NoNoHistorical
71335-3131-37133531310390 CAPSULE in 1 BOTTLE (71335-3131-3) 90 capsule2026-05-21NoNoHistorical
71335-3131-47133531310460 CAPSULE in 1 BOTTLE (71335-3131-4) 60 capsule2026-05-21NoNoHistorical