FDA.reportPublic FDA data

Terazosin

Product NDC
62135-458
11-digit product format
621350458
Labeler code
62135
Product ID
62135-458_45adc1ec-ddd8-7c36-e063-6294a90a46a8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Terazosin
Dosage form
CAPSULE
Route
ORAL
Labeler
Chartwell RX, LLC
Application
ANDA075614
Marketing category
ANDA
Marketing start
2021-04-30
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
62135-458-90Terazosin90 in 1 BOTTLECAPSULE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-458-90EA - Each62135-458796142a5-2ada-4fe8-b0b4-934e3dd57b0b12023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-458TERAZOSIN CAPSULE [CHARTWELL RX, LLC]1Current NDC, 1 package rows20230211_da4ca0f8-6888-447e-9948-d37196c5a19a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313215terazosin HCl 1 MG Oral CapsulePSNda4ca0f8-6888-447e-9948-d37196c5a19a2
260376terazosin HCl 10 MG Oral CapsulePSNda4ca0f8-6888-447e-9948-d37196c5a19a2
313217terazosin HCl 2 MG Oral CapsulePSNda4ca0f8-6888-447e-9948-d37196c5a19a2
313219terazosin HCl 5 MG Oral CapsulePSNda4ca0f8-6888-447e-9948-d37196c5a19a2
313215terazosin 1 MG Oral CapsuleSCDda4ca0f8-6888-447e-9948-d37196c5a19a2
260376terazosin 10 MG Oral CapsuleSCDda4ca0f8-6888-447e-9948-d37196c5a19a2
313217terazosin 2 MG Oral CapsuleSCDda4ca0f8-6888-447e-9948-d37196c5a19a2
313219terazosin 5 MG Oral CapsuleSCDda4ca0f8-6888-447e-9948-d37196c5a19a2
313215terazosin (as terazosin HCl) 1 MG Oral CapsuleSYda4ca0f8-6888-447e-9948-d37196c5a19a2
260376terazosin (as terazosin HCl) 10 MG Oral CapsuleSYda4ca0f8-6888-447e-9948-d37196c5a19a2
313217terazosin (as terazosin HCl) 2 MG Oral CapsuleSYda4ca0f8-6888-447e-9948-d37196c5a19a2
313219terazosin (as terazosin hydrochloride) 5 MG Oral CapsuleSYda4ca0f8-6888-447e-9948-d37196c5a19a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62135-458-906213504589090 CAPSULE in 1 BOTTLE (62135-458-90) 90 capsule2023-02-01NoNoCurrent