FDA.reportPublic FDA data

Terazosin

Product NDC
50268-764
11-digit product format
502680764
Labeler code
50268
Product ID
50268-764_38f32e51-5ff7-7191-e063-6294a90ae02b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Terazosin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
AvPAK
Application
ANDA075317
Marketing category
ANDA
Marketing start
2020-02-13
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TERAZOSIN HYDROCHLORIDE1 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
50268-764-11Terazosin1 in 1 BLISTER PACKCAPSULE15
50268-764-15Terazosin50 in 1 BOXCAPSULE505

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-764-11EA - Each50268-76406b46837-8d22-4398-917e-bb2486dceed012020-03-10
50268-764-15EA - Each50268-764e2c91ac8-6a87-4956-ac12-635c2f1633de12020-03-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-764TERAZOSIN (TERAZOSIN HYDROCHLORIDE) CAPSULE [AVPAK]4Current NDC, Legacy NDC, 2 package rows20220507_9e7b27a6-cc09-407e-e053-2a95a90a17b3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313215terazosin HCl 1 MG Oral CapsulePSN9e7b27a6-cc09-407e-e053-2a95a90a17b35
260376terazosin HCl 10 MG Oral CapsulePSN9e7b27a6-cc09-407e-e053-2a95a90a17b35
313217terazosin HCl 2 MG Oral CapsulePSN9e7b27a6-cc09-407e-e053-2a95a90a17b35
313219terazosin HCl 5 MG Oral CapsulePSN9e7b27a6-cc09-407e-e053-2a95a90a17b35
313215terazosin 1 MG Oral CapsuleSCD9e7b27a6-cc09-407e-e053-2a95a90a17b35
260376terazosin 10 MG Oral CapsuleSCD9e7b27a6-cc09-407e-e053-2a95a90a17b35
313217terazosin 2 MG Oral CapsuleSCD9e7b27a6-cc09-407e-e053-2a95a90a17b35
313219terazosin 5 MG Oral CapsuleSCD9e7b27a6-cc09-407e-e053-2a95a90a17b35
313215terazosin (as terazosin HCl) 1 MG Oral CapsuleSY9e7b27a6-cc09-407e-e053-2a95a90a17b35
260376terazosin (as terazosin HCl) 10 MG Oral CapsuleSY9e7b27a6-cc09-407e-e053-2a95a90a17b35
313217terazosin (as terazosin HCl) 2 MG Oral CapsuleSY9e7b27a6-cc09-407e-e053-2a95a90a17b35
313219terazosin (as terazosin hydrochloride) 5 MG Oral CapsuleSY9e7b27a6-cc09-407e-e053-2a95a90a17b35

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-764-11502680764111 in 1 BLISTER PACKHistorical
50268-764-155026807641550 BLISTER PACK in 1 BOX (50268-764-15) / 1 CAPSULE in 1 BLISTER PACK (50268-764-11) 50 blister pack2020-02-130000-00-00NoNoCurrent