FDA.reportPublic FDA data

Terazosin

Product NDC
50090-1559
11-digit product format
500901559
Labeler code
50090
Product ID
50090-1559_20c2b6cd-ed1d-4eb3-a143-5151902b9c30
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
5 mg/1
Pharmacologic classes
Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Terazosin
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TERAZOSIN HYDROCHLORIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiD32S14F082
Rxcui260376, 313217, 313219

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
50090-1559-02023-02-07C16284748780-1f386c649-cc03-0266-e053-dadaa90a7c1aTERAZOSIN CAPSULES, USP
50090-1559-12023-02-07C16284748780-1f386c649-cc03-0266-e053-dadaa90a7c1aTERAZOSIN CAPSULES, USP
50090-1559-02023-01-30C16284748780-1f386c649-cc03-0266-e053-dadaa90a7c1aTERAZOSIN CAPSULES, USP
50090-1559-12023-01-30C16284748780-1f386c649-cc03-0266-e053-dadaa90a7c1aTERAZOSIN CAPSULES, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-1559-0Terazosin30 in 1 BOTTLECAPSULE3031
50090-1559-1Terazosin90 in 1 BOTTLECAPSULE9031

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1559-0EA - Each50090-155954f02752-c2c3-4422-9fb5-74f091567ed012018-11-06
50090-1559-1EA - Each50090-1559ac24bea4-2081-4533-b349-fd607134e69d12018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1559TERAZOSIN (TERAZOSIN HYDROCHLORIDE) CAPSULE [A-S MEDICATION SOLUTIONS]28Current NDC, Legacy NDC, 2 package rows20240810_83bf40fa-6ae1-4811-8dc1-e8c0bcd63d78.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
260376terazosin HCl 10 MG Oral CapsulePSN83bf40fa-6ae1-4811-8dc1-e8c0bcd63d7831
313217terazosin HCl 2 MG Oral CapsulePSN83bf40fa-6ae1-4811-8dc1-e8c0bcd63d7831
313219terazosin HCl 5 MG Oral CapsulePSN83bf40fa-6ae1-4811-8dc1-e8c0bcd63d7831
260376terazosin 10 MG Oral CapsuleSCD83bf40fa-6ae1-4811-8dc1-e8c0bcd63d7831
313217terazosin 2 MG Oral CapsuleSCD83bf40fa-6ae1-4811-8dc1-e8c0bcd63d7831
313219terazosin 5 MG Oral CapsuleSCD83bf40fa-6ae1-4811-8dc1-e8c0bcd63d7831
260376terazosin (as terazosin HCl) 10 MG Oral CapsuleSY83bf40fa-6ae1-4811-8dc1-e8c0bcd63d7831
313217terazosin (as terazosin HCl) 2 MG Oral CapsuleSY83bf40fa-6ae1-4811-8dc1-e8c0bcd63d7831
313219terazosin (as terazosin hydrochloride) 5 MG Oral CapsuleSY83bf40fa-6ae1-4811-8dc1-e8c0bcd63d7831

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-1559-05009015590030 CAPSULE in 1 BOTTLE (50090-1559-0) 30 capsule2014-12-190000-00-00NoNoCurrent
50090-1559-15009015590190 CAPSULE in 1 BOTTLE (50090-1559-1) 90 capsule2014-12-190000-00-00NoNoCurrent