FDA.reportPublic FDA data

Terazosin

Product NDC
27241-288
11-digit product format
272410288
Labeler code
27241
Product ID
27241-288_ec1b00c3-3d59-420a-a71c-e9bd9a8d02fd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Terazosin
Dosage form
CAPSULE
Route
ORAL
Labeler
Ajanta Pharma USA Inc.
Application
ANDA219482
Marketing category
ANDA
Marketing start
2025-05-12
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
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 HYDROCHLORIDE1 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiD32S14F082
Rxcui260376, 313215, 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
27241-288-01Terazosin100 in 1 BOTTLECAPSULE1003
27241-288-10Terazosin1000 in 1 BOTTLECAPSULE10003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
27241-288-01EA - Each27241-2882b6d76cc-7ea5-45af-801a-b45fb36ed12312025-12-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
27241-288TERAZOSIN CAPSULE [AJANTA PHARMA USA INC.]2Current NDC, 2 package rows20250516_bed99c2a-4266-4a2c-bb0f-7643fdafff78.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313215terazosin HCl 1 MG Oral CapsulePSNbed99c2a-4266-4a2c-bb0f-7643fdafff783
260376terazosin HCl 10 MG Oral CapsulePSNbed99c2a-4266-4a2c-bb0f-7643fdafff783
313217terazosin HCl 2 MG Oral CapsulePSNbed99c2a-4266-4a2c-bb0f-7643fdafff783
313219terazosin HCl 5 MG Oral CapsulePSNbed99c2a-4266-4a2c-bb0f-7643fdafff783
313215terazosin 1 MG Oral CapsuleSCDbed99c2a-4266-4a2c-bb0f-7643fdafff783
260376terazosin 10 MG Oral CapsuleSCDbed99c2a-4266-4a2c-bb0f-7643fdafff783
313217terazosin 2 MG Oral CapsuleSCDbed99c2a-4266-4a2c-bb0f-7643fdafff783
313219terazosin 5 MG Oral CapsuleSCDbed99c2a-4266-4a2c-bb0f-7643fdafff783
313215terazosin (as terazosin HCl) 1 MG Oral CapsuleSYbed99c2a-4266-4a2c-bb0f-7643fdafff783
260376terazosin (as terazosin HCl) 10 MG Oral CapsuleSYbed99c2a-4266-4a2c-bb0f-7643fdafff783
313217terazosin (as terazosin HCl) 2 MG Oral CapsuleSYbed99c2a-4266-4a2c-bb0f-7643fdafff783
313219terazosin (as terazosin hydrochloride) 5 MG Oral CapsuleSYbed99c2a-4266-4a2c-bb0f-7643fdafff783

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
27241-288-0127241028801100 CAPSULE in 1 BOTTLE (27241-288-01) 100 capsule2025-05-12NoNoCurrent
27241-288-10272410288101000 CAPSULE in 1 BOTTLE (27241-288-10) 1000 capsule2025-05-12NoNoCurrent