FDA.reportPublic FDA data

Terazosin

Product NDC
71610-720
11-digit product format
716100720
Labeler code
71610
Product ID
71610-720_36abefd8-65ef-4ad1-8454-2ac6570b85cd
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
2 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 HYDROCHLORIDE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiD32S14F082
Rxcui313217

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
71610-720-30Terazosin30 in 1 BOTTLECAPSULE302
71610-720-53Terazosin60 in 1 BOTTLECAPSULE602
71610-720-60Terazosin90 in 1 BOTTLECAPSULE902
71610-720-70Terazosin120 in 1 BOTTLECAPSULE1202
71610-720-80Terazosin180 in 1 BOTTLECAPSULE1802
71610-720-92Terazosin270 in 1 BOTTLECAPSULE2702
71610-720-94Terazosin360 in 1 BOTTLECAPSULE3602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-720-80EA - Each71610-7207024fa5f-d722-4686-acda-7d9a17eb24c812023-12-05
71610-720-92EA - Each71610-720e6f56581-21d1-47a4-b4e7-8891b6e1b87712024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-720TERAZOSIN (TERAZOSIN HYDROCHLORIDE) CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Current NDC, 7 package rows20230721_0574d9ae-04da-4cb2-b124-9d920012c411.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313217terazosin HCl 2 MG Oral CapsulePSN0574d9ae-04da-4cb2-b124-9d920012c4112
313217terazosin 2 MG Oral CapsuleSCD0574d9ae-04da-4cb2-b124-9d920012c4112
313217terazosin (as terazosin HCl) 2 MG Oral CapsuleSY0574d9ae-04da-4cb2-b124-9d920012c4112

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71610-720-307161007203030 CAPSULE in 1 BOTTLE (71610-720-30) 30 capsule2023-07-18NoNoCurrent
71610-720-537161007205360 CAPSULE in 1 BOTTLE (71610-720-53) 60 capsule2023-07-18NoNoCurrent
71610-720-607161007206090 CAPSULE in 1 BOTTLE (71610-720-60) 90 capsule2023-07-18NoNoCurrent
71610-720-7071610072070120 CAPSULE in 1 BOTTLE (71610-720-70) 120 capsule2023-07-18NoNoCurrent
71610-720-8071610072080180 CAPSULE in 1 BOTTLE (71610-720-80) 180 capsule2023-07-18NoNoCurrent
71610-720-9271610072092270 CAPSULE in 1 BOTTLE (71610-720-92) 270 capsule2023-07-18NoNoCurrent
71610-720-9471610072094360 CAPSULE in 1 BOTTLE (71610-720-94) 360 capsule2023-07-18NoNoCurrent