FDA.reportPublic FDA data

terazosin

Product NDC
23155-738
11-digit product format
231550738
Labeler code
23155
Product ID
23155-738_daad3537-a1d2-451d-ab24-3d8649ff9487
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
terazosin
Dosage form
CAPSULE
Route
ORAL
Labeler
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application
ANDA075614
Marketing category
ANDA
Marketing start
2021-04-30
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, 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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
8adc9826-3fee-6091-f1ee-af9fd6f9caf8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
23155-738-01terazosin100 in 1 BOTTLECAPSULE1002
23155-738-10terazosin1000 in 1 BOTTLECAPSULE10002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-738-01EA - Each23155-738e86aedb9-5d5a-4bfb-8111-29ff33e961c512021-06-02
23155-738-10EA - Each23155-7383ed616e3-c111-4d66-abb1-a36e15b4304112021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23155-738TERAZOSIN CAPSULE [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]2Current NDC, Legacy NDC, 2 package rows20211111_1dabd4d6-3023-460a-8577-08b3690e7c93.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
260376terazosin HCl 10 MG Oral CapsulePSN2cdbb03d-0ac9-477b-88f6-5d9492277048101
260376terazosin 10 MG Oral CapsuleSCD2cdbb03d-0ac9-477b-88f6-5d9492277048101
260376terazosin (as terazosin HCl) 10 MG Oral CapsuleSY2cdbb03d-0ac9-477b-88f6-5d9492277048101
313215terazosin HCl 1 MG Oral CapsulePSN1dabd4d6-3023-460a-8577-08b3690e7c932
260376terazosin HCl 10 MG Oral CapsulePSN1dabd4d6-3023-460a-8577-08b3690e7c932
313217terazosin HCl 2 MG Oral CapsulePSN1dabd4d6-3023-460a-8577-08b3690e7c932
313219terazosin HCl 5 MG Oral CapsulePSN1dabd4d6-3023-460a-8577-08b3690e7c932
313215terazosin 1 MG Oral CapsuleSCD1dabd4d6-3023-460a-8577-08b3690e7c932
260376terazosin 10 MG Oral CapsuleSCD1dabd4d6-3023-460a-8577-08b3690e7c932
313217terazosin 2 MG Oral CapsuleSCD1dabd4d6-3023-460a-8577-08b3690e7c932
313219terazosin 5 MG Oral CapsuleSCD1dabd4d6-3023-460a-8577-08b3690e7c932
313215terazosin (as terazosin HCl) 1 MG Oral CapsuleSY1dabd4d6-3023-460a-8577-08b3690e7c932
260376terazosin (as terazosin HCl) 10 MG Oral CapsuleSY1dabd4d6-3023-460a-8577-08b3690e7c932
313217terazosin (as terazosin HCl) 2 MG Oral CapsuleSY1dabd4d6-3023-460a-8577-08b3690e7c932
313219terazosin (as terazosin hydrochloride) 5 MG Oral CapsuleSY1dabd4d6-3023-460a-8577-08b3690e7c932

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
23155-738-0123155073801100 CAPSULE in 1 BOTTLE (23155-738-01) 100 capsule2021-04-300000-00-00NoNoCurrent
23155-738-10231550738101000 CAPSULE in 1 BOTTLE (23155-738-10) 1000 capsule2021-04-300000-00-00NoNoCurrent