FDA.reportPublic FDA data

TERAZOSIN HYDROCHLORIDE

Product NDC
63629-4525
11-digit product format
636294525
Labeler code
63629
Product ID
63629-4525_4d6ed7d8-ea11-48da-990b-4f604a847ecb
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
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 HYDROCHLORIDE
Listing expiration
2027-12-31

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
63629-4525-12020-07-21C16284748780-19d75b9d0-638b-f424-e053-dadaa90a57ceTERAZOSIN HYDROCHLORIDE
63629-4525-22020-07-21C16284748780-19d75b9d0-638b-f424-e053-dadaa90a57ceTERAZOSIN HYDROCHLORIDE
63629-4525-32020-07-21C16284748780-19d75b9d0-638b-f424-e053-dadaa90a57ceTERAZOSIN HYDROCHLORIDE
63629-4525-42020-07-21C16284748780-19d75b9d0-638b-f424-e053-dadaa90a57ceTERAZOSIN HYDROCHLORIDE
63629-4525-52020-07-21C16284748780-19d75b9d0-638b-f424-e053-dadaa90a57ceTERAZOSIN HYDROCHLORIDE
63629-4525-62020-07-21C16284748780-19d75b9d0-638b-f424-e053-dadaa90a57ceTERAZOSIN HYDROCHLORIDE
63629-4525-12020-01-31C16284748780-19d75b9d0-638b-f424-e053-dadaa90a57ceTERAZOSIN HYDROCHLORIDE
63629-4525-22020-01-31C16284748780-19d75b9d0-638b-f424-e053-dadaa90a57ceTERAZOSIN HYDROCHLORIDE
63629-4525-32020-01-31C16284748780-19d75b9d0-638b-f424-e053-dadaa90a57ceTERAZOSIN HYDROCHLORIDE
63629-4525-42020-01-31C16284748780-19d75b9d0-638b-f424-e053-dadaa90a57ceTERAZOSIN HYDROCHLORIDE
63629-4525-52020-01-31C16284748780-19d75b9d0-638b-f424-e053-dadaa90a57ceTERAZOSIN HYDROCHLORIDE
63629-4525-62020-01-31C16284748780-19d75b9d0-638b-f424-e053-dadaa90a57ceTERAZOSIN HYDROCHLORIDE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-4525-1TERAZOSIN HYDROCHLORIDE150 in 1 BOTTLECAPSULE1501014
63629-4525-2TERAZOSIN HYDROCHLORIDE30 in 1 BOTTLECAPSULE301014
63629-4525-3TERAZOSIN HYDROCHLORIDE90 in 1 BOTTLECAPSULE901014
63629-4525-4TERAZOSIN HYDROCHLORIDE100 in 1 BOTTLECAPSULE1001014
63629-4525-5TERAZOSIN HYDROCHLORIDE28 in 1 BOTTLECAPSULE281014
63629-4525-6TERAZOSIN HYDROCHLORIDE60 in 1 BOTTLECAPSULE601014

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TERAZOSIN HYDROCHLORIDEACTIVE INGREDIENTD32S14F082TERAZOSIN HYDROCHLORIDE (TERAZOSIN HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]1000
TERAZOSINACTIVE MOIETY8L5014XET7TERAZOSIN HYDROCHLORIDE (TERAZOSIN HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]1000
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357TERAZOSIN HYDROCHLORIDE (TERAZOSIN HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]1000
GELATININACTIVE INGREDIENT2G86QN327LTERAZOSIN HYDROCHLORIDE (TERAZOSIN HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]1000
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTERAZOSIN HYDROCHLORIDE (TERAZOSIN HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]1000
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TERAZOSIN HYDROCHLORIDE (TERAZOSIN HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]1000
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TERAZOSIN HYDROCHLORIDE (TERAZOSIN HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]1000
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JTERAZOSIN HYDROCHLORIDE (TERAZOSIN HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]1000
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTERAZOSIN HYDROCHLORIDE (TERAZOSIN HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]1000

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313215terazosin HCl 1 MG Oral CapsulePSN2c42171e-1b44-4d34-b6ca-5b6a94f0e6941014
313215terazosin 1 MG Oral CapsuleSCD2c42171e-1b44-4d34-b6ca-5b6a94f0e6941014
313215terazosin (as terazosin HCl) 1 MG Oral CapsuleSY2c42171e-1b44-4d34-b6ca-5b6a94f0e6941014

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-4525-163629452501150 CAPSULE in 1 BOTTLE (63629-4525-1) 150 capsule2011-07-060000-00-00NoNoCurrent
63629-4525-26362945250230 CAPSULE in 1 BOTTLE (63629-4525-2) 30 capsule2011-07-060000-00-00NoNoCurrent
63629-4525-36362945250390 CAPSULE in 1 BOTTLE (63629-4525-3) 90 capsule2011-07-060000-00-00NoNoCurrent
63629-4525-463629452504100 CAPSULE in 1 BOTTLE (63629-4525-4) 100 capsule2011-07-060000-00-00NoNoCurrent
63629-4525-56362945250528 CAPSULE in 1 BOTTLE (63629-4525-5) 28 capsule2011-07-060000-00-00NoNoCurrent
63629-4525-66362945250660 CAPSULE in 1 BOTTLE (63629-4525-6) 60 capsule2011-07-060000-00-00NoNoCurrent