FDA.reportPublic FDA data

Terazosin

Product NDC
71610-786
11-digit product format
716100786
Labeler code
71610
Product ID
71610-786_fe1153e9-3889-495c-980c-b72d35bb75c0
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
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
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
71610-786-60Terazosin90 in 1 BOTTLECAPSULE902
71610-786-80Terazosin180 in 1 BOTTLECAPSULE1802

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-786-60EA - Each71610-786d27d62a5-9614-411c-bed0-1dbaf66c1f7512024-03-12
71610-786-80EA - Each71610-786c8688354-1063-4210-a401-6d34b9d0394512024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-786TERAZOSIN (TERAZOSIN HYDROCHLORIDE) CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Current NDC, 2 package rows20240207_363a6c85-e5e9-4521-9065-37a7c45bb525.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313219terazosin HCl 5 MG Oral CapsulePSN363a6c85-e5e9-4521-9065-37a7c45bb5252
313219terazosin 5 MG Oral CapsuleSCD363a6c85-e5e9-4521-9065-37a7c45bb5252
313219terazosin (as terazosin hydrochloride) 5 MG Oral CapsuleSY363a6c85-e5e9-4521-9065-37a7c45bb5252

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71610-786-607161007866090 CAPSULE in 1 BOTTLE (71610-786-60) 90 capsule2024-01-25NoNoHistorical
71610-786-8071610078680180 CAPSULE in 1 BOTTLE (71610-786-80) 180 capsule2024-01-25NoNoHistorical