FDA.reportPublic FDA data

Terazosin Hydrochloride

Product NDC
24689-882
11-digit product format
246890882
Labeler code
24689
Product ID
24689-882_2d125642-5083-4147-e063-6394a90a329c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Terazosin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Apnar Pharma LP
Application
ANDA074823
Marketing category
ANDA
Marketing start
2020-06-30
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 Hydrochloride
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
24689-882-01Terazosin Hydrochloride100 in 1 BOTTLECAPSULE10012
24689-882-03Terazosin Hydrochloride90 in 1 BOTTLECAPSULE9012
24689-882-10Terazosin Hydrochloride1000 in 1 BOTTLECAPSULE100012

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24689-882TERAZOSIN HYDROCHLORIDE CAPSULE [APNAR PHARMA LP]12Current NDC, Legacy NDC, 3 package rows20250210_a9176551-3da9-34c1-e053-2995a90a3aee.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313215terazosin HCl 1 MG Oral CapsulePSNa9176551-3da9-34c1-e053-2995a90a3aee12
260376terazosin HCl 10 MG Oral CapsulePSNa9176551-3da9-34c1-e053-2995a90a3aee12
313217terazosin HCl 2 MG Oral CapsulePSNa9176551-3da9-34c1-e053-2995a90a3aee12
313219terazosin HCl 5 MG Oral CapsulePSNa9176551-3da9-34c1-e053-2995a90a3aee12
313215terazosin 1 MG Oral CapsuleSCDa9176551-3da9-34c1-e053-2995a90a3aee12
260376terazosin 10 MG Oral CapsuleSCDa9176551-3da9-34c1-e053-2995a90a3aee12
313217terazosin 2 MG Oral CapsuleSCDa9176551-3da9-34c1-e053-2995a90a3aee12
313219terazosin 5 MG Oral CapsuleSCDa9176551-3da9-34c1-e053-2995a90a3aee12
313215terazosin (as terazosin HCl) 1 MG Oral CapsuleSYa9176551-3da9-34c1-e053-2995a90a3aee12
260376terazosin (as terazosin HCl) 10 MG Oral CapsuleSYa9176551-3da9-34c1-e053-2995a90a3aee12
313217terazosin (as terazosin HCl) 2 MG Oral CapsuleSYa9176551-3da9-34c1-e053-2995a90a3aee12
313219terazosin (as terazosin hydrochloride) 5 MG Oral CapsuleSYa9176551-3da9-34c1-e053-2995a90a3aee12
260376terazosin HCl 10 MG Oral CapsulePSNe5507ea6-bdb3-4363-a68b-0478cbb25f4a1
313219terazosin HCl 5 MG Oral CapsulePSNe5507ea6-bdb3-4363-a68b-0478cbb25f4a1
260376terazosin 10 MG Oral CapsuleSCDe5507ea6-bdb3-4363-a68b-0478cbb25f4a1
313219terazosin 5 MG Oral CapsuleSCDe5507ea6-bdb3-4363-a68b-0478cbb25f4a1
260376terazosin (as terazosin HCl) 10 MG Oral CapsuleSYe5507ea6-bdb3-4363-a68b-0478cbb25f4a1
313219terazosin (as terazosin hydrochloride) 5 MG Oral CapsuleSYe5507ea6-bdb3-4363-a68b-0478cbb25f4a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
24689-882-0124689088201100 CAPSULE in 1 BOTTLE (24689-882-01) 100 capsule2020-06-300000-00-00NoNoCurrent
24689-882-032468908820390 CAPSULE in 1 BOTTLE (24689-882-03) 90 capsule2025-02-15NoNoCurrent
24689-882-10246890882101000 CAPSULE in 1 BOTTLE (24689-882-10) 1000 capsule2020-06-300000-00-00NoNoCurrent