FDA.reportPublic FDA data

Terazosin

Product NDC
71610-780
11-digit product format
716100780
Labeler code
71610
Product ID
71610-780_7bb69c4f-3502-457d-9929-2cb37372202b
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
2004-12-20
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
71610-780-60Terazosin90 in 1 BOTTLECAPSULE901
71610-780-80Terazosin180 in 1 BOTTLECAPSULE1801

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-780-60EA - Each71610-78048629cf2-808d-4503-a227-f2a37216b71e12024-03-12
71610-780-80EA - Each71610-78048d316e1-7542-4963-b66a-eaa65d2c851a12024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-780TERAZOSIN (TERAZOSIN HYDROCHLORIDE) CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Current NDC, 2 package rows20240202_85e450c2-1bc3-49f4-ac2b-5aeedc154bba.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
260376terazosin HCl 10 MG Oral CapsulePSN85e450c2-1bc3-49f4-ac2b-5aeedc154bba1
260376terazosin 10 MG Oral CapsuleSCD85e450c2-1bc3-49f4-ac2b-5aeedc154bba1
260376terazosin (as terazosin HCl) 10 MG Oral CapsuleSY85e450c2-1bc3-49f4-ac2b-5aeedc154bba1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71610-780-607161007806090 CAPSULE in 1 BOTTLE (71610-780-60) 90 capsule2024-02-01NoNoCurrent
71610-780-8071610078080180 CAPSULE in 1 BOTTLE (71610-780-80) 180 capsule2024-02-01NoNoCurrent