FDA.reportPublic FDA data

Terazosin

Product NDC
69452-331
11-digit product format
694520331
Labeler code
69452
Product ID
69452-331_29b9921b-6884-e5bb-e063-6394a90aecf6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Terazosin
Dosage form
CAPSULE
Route
ORAL
Labeler
Bionpharma Inc.
Application
ANDA075667
Marketing category
ANDA
Marketing start
2024-03-11
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
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
69452-331-20Terazosin100 in 1 BOTTLECAPSULE1002
69452-331-32Terazosin1000 in 1 BOTTLECAPSULE10002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69452-331-20EA - Each69452-3319c21ebb8-823e-4ab2-b0bd-774e239e7e1c12024-05-16
69452-331-32EA - Each69452-331d903fe58-c8d3-4dc0-920c-e3f31ca2f94d12025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69452-331TERAZOSIN CAPSULE [BIONPHARMA INC.]2Current NDC, 2 package rows20241222_130c84dc-b598-660f-e063-6294a90a8e46.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313215terazosin HCl 1 MG Oral CapsulePSN130c84dc-b598-660f-e063-6294a90a8e462
260376terazosin HCl 10 MG Oral CapsulePSN130c84dc-b598-660f-e063-6294a90a8e462
313217terazosin HCl 2 MG Oral CapsulePSN130c84dc-b598-660f-e063-6294a90a8e462
313219terazosin HCl 5 MG Oral CapsulePSN130c84dc-b598-660f-e063-6294a90a8e462
313215terazosin 1 MG Oral CapsuleSCD130c84dc-b598-660f-e063-6294a90a8e462
260376terazosin 10 MG Oral CapsuleSCD130c84dc-b598-660f-e063-6294a90a8e462
313217terazosin 2 MG Oral CapsuleSCD130c84dc-b598-660f-e063-6294a90a8e462
313219terazosin 5 MG Oral CapsuleSCD130c84dc-b598-660f-e063-6294a90a8e462
313215terazosin (as terazosin HCl) 1 MG Oral CapsuleSY130c84dc-b598-660f-e063-6294a90a8e462
260376terazosin (as terazosin HCl) 10 MG Oral CapsuleSY130c84dc-b598-660f-e063-6294a90a8e462
313217terazosin (as terazosin HCl) 2 MG Oral CapsuleSY130c84dc-b598-660f-e063-6294a90a8e462
313219terazosin (as terazosin hydrochloride) 5 MG Oral CapsuleSY130c84dc-b598-660f-e063-6294a90a8e462
313217terazosin HCl 2 MG Oral CapsulePSN5c55d942-35c1-46f6-af89-2a0f68f3ea991
313217terazosin HCl 2 MG Oral CapsulePSNa16abe41-98e7-4e60-8c1b-911c6a29f0a21
313217terazosin HCl 2 MG Oral CapsulePSNd1718217-ddab-4a3a-a862-8c952fd5a2741
313217terazosin 2 MG Oral CapsuleSCD5c55d942-35c1-46f6-af89-2a0f68f3ea991
313217terazosin 2 MG Oral CapsuleSCDa16abe41-98e7-4e60-8c1b-911c6a29f0a21
313217terazosin 2 MG Oral CapsuleSCDd1718217-ddab-4a3a-a862-8c952fd5a2741
313217terazosin (as terazosin HCl) 2 MG Oral CapsuleSY5c55d942-35c1-46f6-af89-2a0f68f3ea991
313217terazosin (as terazosin HCl) 2 MG Oral CapsuleSYa16abe41-98e7-4e60-8c1b-911c6a29f0a21
313217terazosin (as terazosin HCl) 2 MG Oral CapsuleSYd1718217-ddab-4a3a-a862-8c952fd5a2741

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69452-331-2069452033120100 CAPSULE in 1 BOTTLE (69452-331-20) 100 capsule2024-03-11NoNoCurrent
69452-331-32694520331321000 CAPSULE in 1 BOTTLE (69452-331-32) 1000 capsule2024-12-20NoNoCurrent