Terazosin Hydrochloride

Product NDC
63629-1414
11-digit product format
636291414
Labeler code
63629
Product ID
63629-1414_73f4a6d7-345b-48da-b77c-b4c90d2ae8cc
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
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 Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TERAZOSIN HYDROCHLORIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiD32S14F082
Rxcui313219

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-1414-1Terazosin Hydrochloride100 in 1 BOTTLECAPSULE1006
63629-1414-2Terazosin Hydrochloride30 in 1 BOTTLECAPSULE306
63629-1414-3Terazosin Hydrochloride90 in 1 BOTTLECAPSULE906
63629-1414-4Terazosin Hydrochloride60 in 1 BOTTLECAPSULE606

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-1414-1EA - Each63629-14145397861d-05cf-40f3-9014-8e313bf7aa1912012-07-24
63629-1414-2EA - Each63629-1414a3cfb71c-77a5-417a-be0b-27c0500d458912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TERAZOSIN HYDROCHLORIDEACTIVE INGREDIENTD32S14F082TERAZOSIN HYDROCHLORIDE (TERAZOSIN HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]1
TERAZOSINACTIVE MOIETY8L5014XET7TERAZOSIN HYDROCHLORIDE (TERAZOSIN HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTERAZOSIN HYDROCHLORIDE (TERAZOSIN HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TERAZOSIN HYDROCHLORIDE (TERAZOSIN HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKTERAZOSIN HYDROCHLORIDE (TERAZOSIN HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]1
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHTERAZOSIN HYDROCHLORIDE (TERAZOSIN HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GTERAZOSIN HYDROCHLORIDE (TERAZOSIN HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDTERAZOSIN HYDROCHLORIDE (TERAZOSIN HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKTERAZOSIN HYDROCHLORIDE (TERAZOSIN HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOATERAZOSIN HYDROCHLORIDE (TERAZOSIN HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357TERAZOSIN HYDROCHLORIDE (TERAZOSIN HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]1
GELATININACTIVE INGREDIENT2G86QN327LTERAZOSIN HYDROCHLORIDE (TERAZOSIN HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTERAZOSIN HYDROCHLORIDE (TERAZOSIN HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TERAZOSIN HYDROCHLORIDE (TERAZOSIN HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3TERAZOSIN HYDROCHLORIDE (TERAZOSIN HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]1
SHELLACINACTIVE INGREDIENT46N107B71OTERAZOSIN HYDROCHLORIDE (TERAZOSIN HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TERAZOSIN HYDROCHLORIDE (TERAZOSIN HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JTERAZOSIN HYDROCHLORIDE (TERAZOSIN HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTERAZOSIN HYDROCHLORIDE (TERAZOSIN HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313219terazosin HCl 5 MG Oral CapsulePSNd971811c-d327-4e63-808c-8d553ee471e76
313219terazosin 5 MG Oral CapsuleSCDd971811c-d327-4e63-808c-8d553ee471e76
313219terazosin (as terazosin hydrochloride) 5 MG Oral CapsuleSYd971811c-d327-4e63-808c-8d553ee471e76

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-1414-163629141401100 CAPSULE in 1 BOTTLE (63629-1414-1) 100 capsule2009-09-100000-00-00NoNoCurrent
63629-1414-26362914140230 CAPSULE in 1 BOTTLE (63629-1414-2) 30 capsule2009-09-100000-00-00NoNoCurrent
63629-1414-36362914140390 CAPSULE in 1 BOTTLE (63629-1414-3) 90 capsule2009-09-100000-00-00NoNoCurrent
63629-1414-46362914140460 CAPSULE in 1 BOTTLE (63629-1414-4) 60 capsule2009-09-100000-00-00NoNoCurrent