FDA.reportPublic FDA data

Terazosin Hydrochloride

Product NDC
71610-698
11-digit product format
716100698
Labeler code
71610
Product ID
71610-698_c97f447e-0233-4a6c-9bed-7dec551aaa95
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
2 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 HYDROCHLORIDE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiD32S14F082
Rxcui313217

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
71610-698-30Terazosin Hydrochloride30 in 1 BOTTLECAPSULE301
71610-698-53Terazosin Hydrochloride60 in 1 BOTTLECAPSULE601
71610-698-60Terazosin Hydrochloride90 in 1 BOTTLECAPSULE901
71610-698-70Terazosin Hydrochloride120 in 1 BOTTLECAPSULE1201
71610-698-80Terazosin Hydrochloride180 in 1 BOTTLECAPSULE1801
71610-698-92Terazosin Hydrochloride270 in 1 BOTTLECAPSULE2701
71610-698-94Terazosin Hydrochloride360 in 1 BOTTLECAPSULE3601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-698-60EA - Each71610-698e57cf674-470f-4952-83fc-edb43425033412024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-698TERAZOSIN HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Current NDC, 7 package rows20230411_9199083d-403f-4c9e-90e1-713ed0a07903.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313217terazosin HCl 2 MG Oral CapsulePSN9199083d-403f-4c9e-90e1-713ed0a079031
313217terazosin 2 MG Oral CapsuleSCD9199083d-403f-4c9e-90e1-713ed0a079031
313217terazosin (as terazosin HCl) 2 MG Oral CapsuleSY9199083d-403f-4c9e-90e1-713ed0a079031

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71610-698-307161006983030 CAPSULE in 1 BOTTLE (71610-698-30) 30 capsule2023-04-04NoNoCurrent
71610-698-537161006985360 CAPSULE in 1 BOTTLE (71610-698-53) 60 capsule2023-04-04NoNoCurrent
71610-698-607161006986090 CAPSULE in 1 BOTTLE (71610-698-60) 90 capsule2023-04-04NoNoCurrent
71610-698-7071610069870120 CAPSULE in 1 BOTTLE (71610-698-70) 120 capsule2023-04-04NoNoCurrent
71610-698-8071610069880180 CAPSULE in 1 BOTTLE (71610-698-80) 180 capsule2023-04-04NoNoCurrent
71610-698-9271610069892270 CAPSULE in 1 BOTTLE (71610-698-92) 270 capsule2023-04-04NoNoCurrent
71610-698-9471610069894360 CAPSULE in 1 BOTTLE (71610-698-94) 360 capsule2023-04-04NoNoCurrent