Prazosin Hydrochloride

Product NDC
51079-630
11-digit product format
510790630
Labeler code
51079
Product ID
51079-630_3a874e40-912d-740d-e063-6394a90a4778
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
prazosin hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Mylan Institutional Inc.
Application
ANDA072575
Marketing category
ANDA
Marketing start
1998-10-05
Substance
PRAZOSIN 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
Prazosin Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PRAZOSIN HYDROCHLORIDE1 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX0Z7454B90
Rxcui198141, 312593, 312594

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d5a3de99-75de-4527-38ae-07b1328b93cbProduct name520250331

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51079-630-01Prazosin Hydrochloride1 in 1 BLISTER PACKCAPSULE112
51079-630-20Prazosin Hydrochloride100 in 1 CARTONCAPSULE10012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51079-630-01EA - Each51079-6304f069d24-6fef-4f16-8c57-31ddf1f9fa8d12013-02-13
51079-630-20EA - Each51079-6301179b279-47de-4131-bb03-d4de32244df012013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PRAZOSIN HYDROCHLORIDEACTIVE INGREDIENTX0Z7454B90PRAZOSIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
PRAZOSINACTIVE MOIETYXM03YJ541DPRAZOSIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
AMMONIAINACTIVE INGREDIENT5138Q19F1XPRAZOSIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPRAZOSIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHPRAZOSIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPRAZOSIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPRAZOSIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SPRAZOSIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAPRAZOSIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675PRAZOSIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTPRAZOSIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357PRAZOSIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
GELATININACTIVE INGREDIENT2G86QN327LPRAZOSIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPRAZOSIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PRAZOSIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PRAZOSIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
SHELLACINACTIVE INGREDIENT46N107B71OPRAZOSIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PRAZOSIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPRAZOSIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51079-630PRAZOSIN HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]11Current NDC, Legacy NDC, 2 package rows20241010_e6a029b2-802f-4cc5-8795-20e177e8d779.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312593prazosin HCl 1 MG Oral CapsulePSNe6a029b2-802f-4cc5-8795-20e177e8d77912
312594prazosin HCl 2 MG Oral CapsulePSNe6a029b2-802f-4cc5-8795-20e177e8d77912
198141prazosin HCl 5 MG Oral CapsulePSNe6a029b2-802f-4cc5-8795-20e177e8d77912
312593prazosin 1 MG Oral CapsuleSCDe6a029b2-802f-4cc5-8795-20e177e8d77912
312594prazosin 2 MG Oral CapsuleSCDe6a029b2-802f-4cc5-8795-20e177e8d77912
198141prazosin 5 MG Oral CapsuleSCDe6a029b2-802f-4cc5-8795-20e177e8d77912
312593prazosin (as prazosin HCl) 1 MG Oral CapsuleSYe6a029b2-802f-4cc5-8795-20e177e8d77912
312594prazosin (as prazosin HCl) 2 MG Oral CapsuleSYe6a029b2-802f-4cc5-8795-20e177e8d77912
198141prazosin (as prazosin HCl) 5 MG Oral CapsuleSYe6a029b2-802f-4cc5-8795-20e177e8d77912

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51079-630-01510790630011 in 1 BLISTER PACKHistorical
51079-630-2051079063020100 BLISTER PACK in 1 CARTON (51079-630-20) / 1 CAPSULE in 1 BLISTER PACK (51079-630-01) 100 blister pack1998-10-050000-00-00NoNoCurrent