FDA.reportPublic FDA data

Terazosin

Product NDC
63187-620
11-digit product format
631870620
Labeler code
63187
Product ID
63187-620_4b095509-2a35-488c-a8d5-f5834be0d31f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Terazosin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA075317
Marketing category
ANDA
Marketing start
2004-12-21
Substance
TERAZOSIN HYDROCHLORIDE
Active strength
10 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 HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiD32S14F082
Rxcui260376

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
63187-620-30Terazosin30 in 1 BOTTLECAPSULE304
63187-620-60Terazosin60 in 1 BOTTLECAPSULE604
63187-620-90Terazosin90 in 1 BOTTLECAPSULE904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-620TERAZOSIN (TERAZOSIN HYDROCHLORIDE) CAPSULE [PROFICIENT RX LP]4Current NDC, Legacy NDC, 3 package rows20221027_27f8952a-189d-4687-854e-c51da619bf3d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
260376terazosin HCl 10 MG Oral CapsulePSN27f8952a-189d-4687-854e-c51da619bf3d4
260376terazosin 10 MG Oral CapsuleSCD27f8952a-189d-4687-854e-c51da619bf3d4
260376terazosin (as terazosin HCl) 10 MG Oral CapsuleSY27f8952a-189d-4687-854e-c51da619bf3d4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-620-306318706203030 CAPSULE in 1 BOTTLE (63187-620-30) 30 capsule2018-12-010000-00-00NoNoCurrent
63187-620-606318706206060 CAPSULE in 1 BOTTLE (63187-620-60) 60 capsule2018-12-010000-00-00NoNoCurrent
63187-620-906318706209090 CAPSULE in 1 BOTTLE (63187-620-90) 90 capsule2018-12-010000-00-00NoNoCurrent