FDA.reportPublic FDA data

Terazosin

Product NDC
63629-5237
11-digit product format
636295237
Labeler code
63629
Product ID
63629-5237_1b04f70e-e8d8-4005-82f5-53b9cf3c4e99
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, 313217

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
63629-5237-1Terazosin30 in 1 BOTTLECAPSULE301012
63629-5237-2Terazosin28 in 1 BOTTLECAPSULE281012
63629-5237-3Terazosin90 in 1 BOTTLECAPSULE901012

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-5237TERAZOSIN (TERAZOSIN HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]1011Current NDC, Legacy NDC, 3 package rows20200903_521e4aad-c6ec-4410-867f-dd9ecc08d5b2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
260376terazosin HCl 10 MG Oral CapsulePSN521e4aad-c6ec-4410-867f-dd9ecc08d5b21012
313217terazosin HCl 2 MG Oral CapsulePSN521e4aad-c6ec-4410-867f-dd9ecc08d5b21012
260376terazosin 10 MG Oral CapsuleSCD521e4aad-c6ec-4410-867f-dd9ecc08d5b21012
313217terazosin 2 MG Oral CapsuleSCD521e4aad-c6ec-4410-867f-dd9ecc08d5b21012
260376terazosin (as terazosin HCl) 10 MG Oral CapsuleSY521e4aad-c6ec-4410-867f-dd9ecc08d5b21012
313217terazosin (as terazosin HCl) 2 MG Oral CapsuleSY521e4aad-c6ec-4410-867f-dd9ecc08d5b21012

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-5237-16362952370130 CAPSULE in 1 BOTTLE (63629-5237-1) 30 capsule2014-02-130000-00-00NoNoCurrent
63629-5237-26362952370228 CAPSULE in 1 BOTTLE (63629-5237-2) 28 capsule2014-02-130000-00-00NoNoCurrent
63629-5237-36362952370390 CAPSULE in 1 BOTTLE (63629-5237-3) 90 capsule2014-02-130000-00-00NoNoCurrent