FDA.reportPublic FDA data

Terazosin

Product NDC
42291-822
11-digit product format
422910822
Labeler code
42291
Product ID
42291-822_3a9ec205-cdb5-e131-e063-6294a90acb60
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Terazosin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
AvKARE
Application
ANDA075317
Marketing category
ANDA
Marketing start
2020-03-30
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
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 HYDROCHLORIDE5 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
42291-822-10Terazosin1000 in 1 BOTTLECAPSULE10004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-822-10EA - Each42291-82292dad156-9f2d-4362-981e-92bea33ac50212020-05-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42291-822TERAZOSIN (TERAZOSIN HYDROCHLORIDE) CAPSULE [AVKARE]3Current NDC, Legacy NDC, 1 package rows20241010_a2137488-8554-e84f-e053-2995a90a796c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313215terazosin HCl 1 MG Oral CapsulePSNa2137488-8554-e84f-e053-2995a90a796c4
260376terazosin HCl 10 MG Oral CapsulePSNa2137488-8554-e84f-e053-2995a90a796c4
313217terazosin HCl 2 MG Oral CapsulePSNa2137488-8554-e84f-e053-2995a90a796c4
313219terazosin HCl 5 MG Oral CapsulePSNa2137488-8554-e84f-e053-2995a90a796c4
313215terazosin 1 MG Oral CapsuleSCDa2137488-8554-e84f-e053-2995a90a796c4
260376terazosin 10 MG Oral CapsuleSCDa2137488-8554-e84f-e053-2995a90a796c4
313217terazosin 2 MG Oral CapsuleSCDa2137488-8554-e84f-e053-2995a90a796c4
313219terazosin 5 MG Oral CapsuleSCDa2137488-8554-e84f-e053-2995a90a796c4
313215terazosin (as terazosin HCl) 1 MG Oral CapsuleSYa2137488-8554-e84f-e053-2995a90a796c4
260376terazosin (as terazosin HCl) 10 MG Oral CapsuleSYa2137488-8554-e84f-e053-2995a90a796c4
313217terazosin (as terazosin HCl) 2 MG Oral CapsuleSYa2137488-8554-e84f-e053-2995a90a796c4
313219terazosin (as terazosin hydrochloride) 5 MG Oral CapsuleSYa2137488-8554-e84f-e053-2995a90a796c4
313217terazosin HCl 2 MG Oral CapsulePSN81d5422c-ff57-4f6d-927c-5de4dd7e11691
313219terazosin HCl 5 MG Oral CapsulePSN81d5422c-ff57-4f6d-927c-5de4dd7e11691
313217terazosin 2 MG Oral CapsuleSCD81d5422c-ff57-4f6d-927c-5de4dd7e11691
313219terazosin 5 MG Oral CapsuleSCD81d5422c-ff57-4f6d-927c-5de4dd7e11691
313217terazosin (as terazosin HCl) 2 MG Oral CapsuleSY81d5422c-ff57-4f6d-927c-5de4dd7e11691
313219terazosin (as terazosin hydrochloride) 5 MG Oral CapsuleSY81d5422c-ff57-4f6d-927c-5de4dd7e11691

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42291-822-10422910822101000 CAPSULE in 1 BOTTLE (42291-822-10) 1000 capsule2020-03-300000-00-00NoNoCurrent