FDA.reportPublic FDA data

Terazosin

Product NDC
72162-1702
11-digit product format
721621702
Labeler code
72162
Product ID
72162-1702_a55a5e8b-d486-40ea-9d43-d296e6fc2a9f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Terazosin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
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
72162-1702-0Terazosin1000 in 1 BOTTLECAPSULE1000103
72162-1702-1Terazosin100 in 1 BOTTLECAPSULE100103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1702-0EA - Each72162-170221fcd070-637f-4d9b-9314-15edd186273312024-02-14
72162-1702-1EA - Each72162-170211a67300-9319-424b-8529-75fb03bb83e912024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1702TERAZOSIN (TERAZOSIN HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]102Current NDC, 2 package rows20240209_458b4a60-b2d6-445a-8638-7fcd07decf66.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
260376terazosin HCl 10 MG Oral CapsulePSN458b4a60-b2d6-445a-8638-7fcd07decf66103
260376terazosin 10 MG Oral CapsuleSCD458b4a60-b2d6-445a-8638-7fcd07decf66103
260376terazosin (as terazosin HCl) 10 MG Oral CapsuleSY458b4a60-b2d6-445a-8638-7fcd07decf66103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-1702-0721621702001000 CAPSULE in 1 BOTTLE (72162-1702-0) 1000 capsule2023-12-07NoNoCurrent
72162-1702-172162170201100 CAPSULE in 1 BOTTLE (72162-1702-1) 100 capsule2023-12-07NoNoCurrent