Terazosin

Product NDC
71610-478
11-digit product format
716100478
Labeler code
71610
Product ID
71610-478_0ff03065-5d3c-4a3e-9a04-207236b7d6f5
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
1 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 HYDROCHLORIDE1 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiD32S14F082
Rxcui313215

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
71610-478-60Terazosin90 in 1 BOTTLECAPSULE901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-478TERAZOSIN (TERAZOSIN HYDROCHLORIDE) CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Current NDC, Legacy NDC, 1 package rows20201113_0d7779b3-02c5-4a74-a749-82ed6ae2c9bc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313215terazosin HCl 1 MG Oral CapsulePSN0d7779b3-02c5-4a74-a749-82ed6ae2c9bc1
313215terazosin 1 MG Oral CapsuleSCD0d7779b3-02c5-4a74-a749-82ed6ae2c9bc1
313215terazosin (as terazosin HCl) 1 MG Oral CapsuleSY0d7779b3-02c5-4a74-a749-82ed6ae2c9bc1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71610-478-607161004786090 CAPSULE in 1 BOTTLE (71610-478-60) 90 capsule2020-10-230000-00-00NoNoCurrent