FDA.reportPublic FDA data

Terazosin

Product NDC
50090-0657
11-digit product format
500900657
Labeler code
50090
Product ID
50090-0657_d0073283-4e97-4e24-a94c-0240ff908c55
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Terazosin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA075317
Marketing category
ANDA
Marketing start
2004-12-20
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-0657-02023-02-02C16284748780-1f386c649-ee72-0266-e053-dadaa90a7c1aTERAZOSIN CAPSULES, USP
50090-0657-12023-02-02C16284748780-1f386c649-ee72-0266-e053-dadaa90a7c1aTERAZOSIN CAPSULES, USP
50090-0657-02023-01-30C16284748780-1f386c649-ee72-0266-e053-dadaa90a7c1aTERAZOSIN CAPSULES, USP
50090-0657-12023-01-30C16284748780-1f386c649-ee72-0266-e053-dadaa90a7c1aTERAZOSIN CAPSULES, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0657-0Terazosin30 in 1 BOTTLECAPSULE3014
50090-0657-1Terazosin90 in 1 BOTTLECAPSULE9014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0657-0EA - Each50090-0657ddfc6b88-b3da-42d5-aa23-ad274108091c12018-10-11
50090-0657-1EA - Each50090-0657a11f8c2e-093b-46cb-ae4d-95460a1da17812018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0657TERAZOSIN (TERAZOSIN HYDROCHLORIDE) CAPSULE [A-S MEDICATION SOLUTIONS]14Current NDC, Legacy NDC, 2 package rows20241108_4b195327-10d4-477f-ada2-d62c7f835e6c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313215terazosin HCl 1 MG Oral CapsulePSN4b195327-10d4-477f-ada2-d62c7f835e6c14
313215terazosin 1 MG Oral CapsuleSCD4b195327-10d4-477f-ada2-d62c7f835e6c14
313215terazosin (as terazosin HCl) 1 MG Oral CapsuleSY4b195327-10d4-477f-ada2-d62c7f835e6c14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-0657-05009006570030 CAPSULE in 1 BOTTLE (50090-0657-0) 30 capsule2014-11-280000-00-00NoNoCurrent
50090-0657-15009006570190 CAPSULE in 1 BOTTLE (50090-0657-1) 90 capsule2014-11-280000-00-00NoNoCurrent