Terazosin

Product NDC
53217-212
11-digit product format
532170212
Labeler code
53217
Product ID
53217-212_9bce3e50-1bf2-4d35-8edf-00d5784a1622
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Terazosin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA075317
Marketing category
ANDA
Marketing start
2004-12-20
Marketing end
0000-00-00
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
2019-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53217-212-302020-01-31C16284748780-19d75b9d0-4cd8-f424-e053-dadaa90a57ceTERAZOSIN CAPSULES, USP
53217-212-602020-01-31C16284748780-19d75b9d0-4cd8-f424-e053-dadaa90a57ceTERAZOSIN CAPSULES, USP
53217-212-902020-01-31C16284748780-19d75b9d0-4cd8-f424-e053-dadaa90a57ceTERAZOSIN CAPSULES, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53217-212-30Terazosin30 in 1 BOTTLECAPSULE301
53217-212-60Terazosin60 in 1 BOTTLECAPSULE601
53217-212-90Terazosin90 in 1 BOTTLECAPSULE901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53217-212TERAZOSIN (TERAZOSIN HYDROCHLORIDE) CAPSULE [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 3 package rows20160727_dfcd267e-a965-4942-987a-766a7305f421.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313217terazosin HCl 2 MG Oral CapsulePSNdfcd267e-a965-4942-987a-766a7305f4211
313217terazosin 2 MG Oral CapsuleSCDdfcd267e-a965-4942-987a-766a7305f4211
313217terazosin (as terazosin HCl) 2 MG Oral CapsuleSYdfcd267e-a965-4942-987a-766a7305f4211

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53217-212-305321702123030 in 1 BOTTLEHistorical
53217-212-605321702126060 in 1 BOTTLEHistorical
53217-212-905321702129090 in 1 BOTTLEHistorical