Terazosin

Product NDC
10544-289
11-digit product format
105440289
Labeler code
10544
Product ID
10544-289_0f547137-d43b-15f6-e054-00144ff8d46c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Terazosin
Dosage form
CAPSULE
Route
ORAL
Labeler
Blenheim Pharmacal, Inc.
Application
ANDA075498
Marketing category
ANDA
Marketing start
2013-11-18
Marketing end
0000-00-00
Substance
TERAZOSIN HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
8adc9826-3fee-6091-f1ee-af9fd6f9caf8Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10544-289-302020-01-31C16284748780-19d75b9d0-ddb3-f424-e053-dadaa90a57ceTerazosin Capsules, 1mg, 2mg, 5mg and 10 mg
10544-289-902020-01-31C16284748780-19d75b9d0-ddb3-f424-e053-dadaa90a57ceTerazosin Capsules, 1mg, 2mg, 5mg and 10 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10544-289-30Terazosin30 in 1 BOTTLECAPSULE301
10544-289-90Terazosin90 in 1 BOTTLECAPSULE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10544-289-30EA - Each10544-2890ae342df-272b-4a71-ad15-411fc0efd11612015-06-09
10544-289-90EA - Each10544-289a4af623b-4308-482c-84a3-62190172951512015-06-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TERAZOSIN HYDROCHLORIDEACTIVE INGREDIENTD32S14F082TERAZOSIN CAPSULE [BLENHEIM PHARMACAL, INC.]1
TERAZOSINACTIVE MOIETY8L5014XET7TERAZOSIN CAPSULE [BLENHEIM PHARMACAL, INC.]1
AMMONIAINACTIVE INGREDIENT5138Q19F1XTERAZOSIN CAPSULE [BLENHEIM PHARMACAL, INC.]1
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHTERAZOSIN CAPSULE [BLENHEIM PHARMACAL, INC.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GTERAZOSIN CAPSULE [BLENHEIM PHARMACAL, INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDTERAZOSIN CAPSULE [BLENHEIM PHARMACAL, INC.]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357TERAZOSIN CAPSULE [BLENHEIM PHARMACAL, INC.]1
GELATININACTIVE INGREDIENT2G86QN327LTERAZOSIN CAPSULE [BLENHEIM PHARMACAL, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTERAZOSIN CAPSULE [BLENHEIM PHARMACAL, INC.]1
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TTERAZOSIN CAPSULE [BLENHEIM PHARMACAL, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3TERAZOSIN CAPSULE [BLENHEIM PHARMACAL, INC.]1
SHELLACINACTIVE INGREDIENT46N107B71OTERAZOSIN CAPSULE [BLENHEIM PHARMACAL, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTERAZOSIN CAPSULE [BLENHEIM PHARMACAL, INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APTERAZOSIN CAPSULE [BLENHEIM PHARMACAL, INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UTERAZOSIN CAPSULE [BLENHEIM PHARMACAL, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTERAZOSIN CAPSULE [BLENHEIM PHARMACAL, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10544-289TERAZOSIN CAPSULE [BLENHEIM PHARMACAL, INC.]1Legacy NDC, 2 package rows20150218_0f547137-d43a-15f6-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
260376terazosin HCl 10 MG Oral CapsulePSN0f547137-d43a-15f6-e054-00144ff8d46c1
260376terazosin 10 MG Oral CapsuleSCD0f547137-d43a-15f6-e054-00144ff8d46c1
260376terazosin (as terazosin HCl) 10 MG Oral CapsuleSY0f547137-d43a-15f6-e054-00144ff8d46c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10544-289-301054402893030 in 1 BOTTLEHistorical
10544-289-901054402899090 in 1 BOTTLEHistorical