FDA.reportPublic FDA data

Terazosin Hydrochloride

Product NDC
71610-854
11-digit product format
716100854
Labeler code
71610
Product ID
71610-854_214d9180-c434-330d-e063-6394a90a795c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Terazosin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA074823
Marketing category
ANDA
Marketing start
2020-06-30
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
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 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71610-854-30Terazosin Hydrochloride30 in 1 BOTTLECAPSULE301
71610-854-53Terazosin Hydrochloride60 in 1 BOTTLECAPSULE601
71610-854-60Terazosin Hydrochloride90 in 1 BOTTLECAPSULE901
71610-854-80Terazosin Hydrochloride180 in 1 BOTTLECAPSULE1801

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-854-30EA - Each71610-854684c33f9-2e31-44a9-bfa8-9c0cf50d5e9412024-12-10
71610-854-53EA - Each71610-8541c0e24c6-7704-46b4-877e-83a298efdd5f12024-12-10
71610-854-60EA - Each71610-8542779f2b0-7f1a-43ac-9042-01d72e93523012024-12-10
71610-854-80EA - Each71610-85475c9f2eb-85dd-41bb-99f2-d9657a70147c12024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-854TERAZOSIN HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC ]1Current NDC, 4 package rows20240906_214d9b06-8d23-3ee8-e063-6394a90a1521.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313215terazosin HCl 1 MG Oral CapsulePSN214d9b06-8d23-3ee8-e063-6394a90a15211
313215terazosin 1 MG Oral CapsuleSCD214d9b06-8d23-3ee8-e063-6394a90a15211
313215terazosin (as terazosin HCl) 1 MG Oral CapsuleSY214d9b06-8d23-3ee8-e063-6394a90a15211

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71610-854-307161008543030 CAPSULE in 1 BOTTLE (71610-854-30) 30 capsule2024-09-03NoNoCurrent
71610-854-537161008545360 CAPSULE in 1 BOTTLE (71610-854-53) 60 capsule2024-09-03NoNoCurrent
71610-854-607161008546090 CAPSULE in 1 BOTTLE (71610-854-60) 90 capsule2024-09-03NoNoCurrent
71610-854-8071610085480180 CAPSULE in 1 BOTTLE (71610-854-80) 180 capsule2024-09-03NoNoCurrent