FDA.reportPublic FDA data

Prazosin Hydrochloride

Product NDC
0378-3205
11-digit product format
003783205
Labeler code
0378
Product ID
0378-3205_96e4be0d-95bb-44e6-bbfd-55d6694a2e02
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
prazosin hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA072575
Marketing category
ANDA
Marketing start
1989-02-28
Substance
PRAZOSIN HYDROCHLORIDE
Active strength
5 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 HYDROCHLORIDE5 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
0378-3205-01Prazosin Hydrochloride100 in 1 BOTTLE, PLASTICCAPSULE10014
0378-3205-25Prazosin Hydrochloride250 in 1 BOTTLE, PLASTICCAPSULE25014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-3205-01EA - Each0378-32053109566f-1f35-4d86-977d-29d7d36d567412012-07-24
0378-3205-25EA - Each0378-3205d29a032d-bddd-4c4d-af4e-272d21f0968612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PRAZOSIN HYDROCHLORIDEACTIVE INGREDIENTX0Z7454B90PRAZOSIN HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]5
PRAZOSINACTIVE MOIETYXM03YJ541DPRAZOSIN HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]5
AMMONIAINACTIVE INGREDIENT5138Q19F1XPRAZOSIN HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPRAZOSIN HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]5
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHPRAZOSIN HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]5
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPRAZOSIN HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]5
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPRAZOSIN HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]5
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SPRAZOSIN HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]5
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAPRAZOSIN HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]5
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675PRAZOSIN HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]5
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTPRAZOSIN HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]5
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357PRAZOSIN HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]5
GELATININACTIVE INGREDIENT2G86QN327LPRAZOSIN HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPRAZOSIN HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PRAZOSIN HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]5
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PRAZOSIN HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]5
SHELLACINACTIVE INGREDIENT46N107B71OPRAZOSIN HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PRAZOSIN HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPRAZOSIN HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]5
PRAZOSIN HYDROCHLORIDEACTIVE INGREDIENTX0Z7454B90PRAZOSIN HYDROCHLORIDE (PRAZOSIN HYDROCHLORIDE) CAPSULE [PD-RX PHARMACEUTICALS, INC.]3
PRAZOSINACTIVE MOIETYXM03YJ541DPRAZOSIN HYDROCHLORIDE (PRAZOSIN HYDROCHLORIDE) CAPSULE [PD-RX PHARMACEUTICALS, INC.]3
AMMONIAINACTIVE INGREDIENT5138Q19F1XPRAZOSIN HYDROCHLORIDE (PRAZOSIN HYDROCHLORIDE) CAPSULE [PD-RX PHARMACEUTICALS, INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPRAZOSIN HYDROCHLORIDE (PRAZOSIN HYDROCHLORIDE) CAPSULE [PD-RX PHARMACEUTICALS, INC.]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPRAZOSIN HYDROCHLORIDE (PRAZOSIN HYDROCHLORIDE) CAPSULE [PD-RX PHARMACEUTICALS, INC.]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675PRAZOSIN HYDROCHLORIDE (PRAZOSIN HYDROCHLORIDE) CAPSULE [PD-RX PHARMACEUTICALS, INC.]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTPRAZOSIN HYDROCHLORIDE (PRAZOSIN HYDROCHLORIDE) CAPSULE [PD-RX PHARMACEUTICALS, INC.]3
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357PRAZOSIN HYDROCHLORIDE (PRAZOSIN HYDROCHLORIDE) CAPSULE [PD-RX PHARMACEUTICALS, INC.]3
GELATININACTIVE INGREDIENT2G86QN327LPRAZOSIN HYDROCHLORIDE (PRAZOSIN HYDROCHLORIDE) CAPSULE [PD-RX PHARMACEUTICALS, INC.]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPRAZOSIN HYDROCHLORIDE (PRAZOSIN HYDROCHLORIDE) CAPSULE [PD-RX PHARMACEUTICALS, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PRAZOSIN HYDROCHLORIDE (PRAZOSIN HYDROCHLORIDE) CAPSULE [PD-RX PHARMACEUTICALS, INC.]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PRAZOSIN HYDROCHLORIDE (PRAZOSIN HYDROCHLORIDE) CAPSULE [PD-RX PHARMACEUTICALS, INC.]3
SHELLACINACTIVE INGREDIENT46N107B71OPRAZOSIN HYDROCHLORIDE (PRAZOSIN HYDROCHLORIDE) CAPSULE [PD-RX PHARMACEUTICALS, INC.]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PRAZOSIN HYDROCHLORIDE (PRAZOSIN HYDROCHLORIDE) CAPSULE [PD-RX PHARMACEUTICALS, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPRAZOSIN HYDROCHLORIDE (PRAZOSIN HYDROCHLORIDE) CAPSULE [PD-RX PHARMACEUTICALS, INC.]3
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
0378-3205PRAZOSIN HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.]14Current NDC, Legacy NDC, 2 package rows20250119_1ce90aaf-d075-4617-9a47-e8d922096d23.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312593prazosin HCl 1 MG Oral CapsulePSN1ce90aaf-d075-4617-9a47-e8d922096d2314
312594prazosin HCl 2 MG Oral CapsulePSN1ce90aaf-d075-4617-9a47-e8d922096d2314
198141prazosin HCl 5 MG Oral CapsulePSN1ce90aaf-d075-4617-9a47-e8d922096d2314
312593prazosin 1 MG Oral CapsuleSCD1ce90aaf-d075-4617-9a47-e8d922096d2314
312594prazosin 2 MG Oral CapsuleSCD1ce90aaf-d075-4617-9a47-e8d922096d2314
198141prazosin 5 MG Oral CapsuleSCD1ce90aaf-d075-4617-9a47-e8d922096d2314
312593prazosin (as prazosin HCl) 1 MG Oral CapsuleSY1ce90aaf-d075-4617-9a47-e8d922096d2314
312594prazosin (as prazosin HCl) 2 MG Oral CapsuleSY1ce90aaf-d075-4617-9a47-e8d922096d2314
198141prazosin (as prazosin HCl) 5 MG Oral CapsuleSY1ce90aaf-d075-4617-9a47-e8d922096d2314
198141prazosin HCl 5 MG Oral CapsulePSN5d7dff44-84b1-4044-bc5a-c76ea11dd5a313
198141prazosin 5 MG Oral CapsuleSCD5d7dff44-84b1-4044-bc5a-c76ea11dd5a313
198141prazosin (as prazosin HCl) 5 MG Oral CapsuleSY5d7dff44-84b1-4044-bc5a-c76ea11dd5a313
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
198141prazosin HCl 5 MG Oral CapsulePSN39e3fa5d-ea48-4b02-80f6-44591f5e013f10
198141prazosin 5 MG Oral CapsuleSCD39e3fa5d-ea48-4b02-80f6-44591f5e013f10
198141prazosin (as prazosin HCl) 5 MG Oral CapsuleSY39e3fa5d-ea48-4b02-80f6-44591f5e013f10
312593prazosin HCl 1 MG Oral CapsulePSN12cdde5b-173c-4f31-a326-3128d521930c2
312594prazosin HCl 2 MG Oral CapsulePSN12cdde5b-173c-4f31-a326-3128d521930c2
198141prazosin HCl 5 MG Oral CapsulePSN12cdde5b-173c-4f31-a326-3128d521930c2
312593prazosin 1 MG Oral CapsuleSCD12cdde5b-173c-4f31-a326-3128d521930c2
312594prazosin 2 MG Oral CapsuleSCD12cdde5b-173c-4f31-a326-3128d521930c2
198141prazosin 5 MG Oral CapsuleSCD12cdde5b-173c-4f31-a326-3128d521930c2
312593prazosin (as prazosin HCl) 1 MG Oral CapsuleSY12cdde5b-173c-4f31-a326-3128d521930c2
312594prazosin (as prazosin HCl) 2 MG Oral CapsuleSY12cdde5b-173c-4f31-a326-3128d521930c2
198141prazosin (as prazosin HCl) 5 MG Oral CapsuleSY12cdde5b-173c-4f31-a326-3128d521930c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0378-3205-0100378320501100 CAPSULE in 1 BOTTLE, PLASTIC (0378-3205-01) 100 capsule1989-02-280000-00-00NoNoCurrent
0378-3205-2500378320525250 CAPSULE in 1 BOTTLE, PLASTIC (0378-3205-25) 250 capsule1989-02-280000-00-00NoNoCurrent