Terazosin Hydrochloride

Product NDC
71610-594
11-digit product format
716100594
Labeler code
71610
Product ID
71610-594_2b26376c-c9c8-4d68-aec5-f3aa773fe7f9
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
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 Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TERAZOSIN HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiD32S14F082
Rxcui260376, 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
71610-594-60Terazosin Hydrochloride90 in 1 BOTTLECAPSULE901
71610-594-80Terazosin Hydrochloride180 in 1 BOTTLECAPSULE1801

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-594-60EA - Each71610-594e081cac5-4b69-4425-9a8d-3013b05c0cec12021-10-08
71610-594-80EA - Each71610-594445a72c4-d921-4189-a23d-1bcc9c050af312021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-594TERAZOSIN HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Current NDC, Legacy NDC, 2 package rows20210829_e5507ea6-bdb3-4363-a68b-0478cbb25f4a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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
71610-594-607161005946090 CAPSULE in 1 BOTTLE (71610-594-60) 90 capsule2021-08-260000-00-00NoNoCurrent
71610-594-8071610059480180 CAPSULE in 1 BOTTLE (71610-594-80) 180 capsule2021-08-260000-00-00NoNoCurrent