FDA.reportPublic FDA data

Terazosin

Product NDC
71610-510
11-digit product format
716100510
Labeler code
71610
Product ID
71610-510_b23a32b3-7e6b-4b58-be96-303ac3ef069a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Terazosin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA075317
Marketing category
ANDA
Marketing start
2020-03-30
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TERAZOSIN HYDROCHLORIDE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiD32S14F082
Rxcui313217, 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
71610-510-30Terazosin30 in 1 BOTTLECAPSULE301
71610-510-53Terazosin60 in 1 BOTTLECAPSULE601
71610-510-60Terazosin90 in 1 BOTTLECAPSULE901
71610-510-70Terazosin120 in 1 BOTTLECAPSULE1201
71610-510-80Terazosin180 in 1 BOTTLECAPSULE1801
71610-510-92Terazosin270 in 1 BOTTLECAPSULE2701
71610-510-94Terazosin360 in 1 BOTTLECAPSULE3601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-510-30EA - Each71610-5104281a5d5-de1d-4d3a-bcf2-88fc667d5c3012021-03-02
71610-510-53EA - Each71610-51028c31a73-423c-42a0-9620-46ff6b5a352012021-03-02
71610-510-60EA - Each71610-510916a6665-c824-4a67-a168-5c04a7e2998412021-03-02
71610-510-70EA - Each71610-51053d304fc-3184-47d5-bd51-add31cc3e41912021-03-02
71610-510-80EA - Each71610-5101c5b1990-4d0c-43be-a6df-95d7908fc26412021-03-02
71610-510-92EA - Each71610-5101b157a30-ea86-4f09-9cef-9b674f46bd1c12021-03-02
71610-510-94EA - Each71610-510a683e7ed-c4c6-4a10-b9e7-ad2d7c173cf912021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-510TERAZOSIN (TERAZOSIN HYDROCHLORIDE) CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Current NDC, Legacy NDC, 7 package rows20210124_81d5422c-ff57-4f6d-927c-5de4dd7e1169.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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
71610-510-307161005103030 CAPSULE in 1 BOTTLE (71610-510-30) 30 capsule2020-12-290000-00-00NoNoCurrent
71610-510-537161005105360 CAPSULE in 1 BOTTLE (71610-510-53) 60 capsule2020-12-290000-00-00NoNoCurrent
71610-510-607161005106090 CAPSULE in 1 BOTTLE (71610-510-60) 90 capsule2020-12-290000-00-00NoNoCurrent
71610-510-7071610051070120 CAPSULE in 1 BOTTLE (71610-510-70) 120 capsule2020-12-290000-00-00NoNoCurrent
71610-510-8071610051080180 CAPSULE in 1 BOTTLE (71610-510-80) 180 capsule2020-12-290000-00-00NoNoCurrent
71610-510-9271610051092270 CAPSULE in 1 BOTTLE (71610-510-92) 270 capsule2020-12-290000-00-00NoNoCurrent
71610-510-9471610051094360 CAPSULE in 1 BOTTLE (71610-510-94) 360 capsule2020-12-290000-00-00NoNoCurrent