FDA.reportPublic FDA data

Prazosin Hydrochloride

Product NDC
0378-1101
11-digit product format
003781101
Labeler code
0378
Product ID
0378-1101_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
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
0378-1101-01Prazosin Hydrochloride100 in 1 BOTTLE, PLASTICCAPSULE10014
0378-1101-10Prazosin Hydrochloride1000 in 1 BOTTLE, PLASTICCAPSULE100014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-1101-01EA - Each0378-1101074767a6-88d1-455f-acee-a23fc84c9e7112012-07-24
0378-1101-10EA - Each0378-1101cf1b45c2-331b-4bc7-a3d9-1f1fd1e0ece312012-07-24

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 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
0378-1101PRAZOSIN 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 CapsulePSN1a92a503-cf5e-48ef-a6fd-79fe98fdd8a0102
312593prazosin 1 MG Oral CapsuleSCD1a92a503-cf5e-48ef-a6fd-79fe98fdd8a0102
312593prazosin (as prazosin HCl) 1 MG Oral CapsuleSY1a92a503-cf5e-48ef-a6fd-79fe98fdd8a0102
312593prazosin HCl 1 MG Oral CapsulePSNe5e129aa-2ee3-4c12-a327-5d5382cf231014
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 CapsuleSCDe5e129aa-2ee3-4c12-a327-5d5382cf231014
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
312593prazosin (as prazosin HCl) 1 MG Oral CapsuleSYe5e129aa-2ee3-4c12-a327-5d5382cf231014
312594prazosin (as prazosin HCl) 2 MG Oral CapsuleSY1ce90aaf-d075-4617-9a47-e8d922096d2314
198141prazosin (as prazosin HCl) 5 MG Oral CapsuleSY1ce90aaf-d075-4617-9a47-e8d922096d2314
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
312593prazosin HCl 1 MG Oral CapsulePSN55e74841-23f1-4cfb-97b2-8bd2d2329b0e9
312593prazosin 1 MG Oral CapsuleSCD55e74841-23f1-4cfb-97b2-8bd2d2329b0e9
312593prazosin (as prazosin HCl) 1 MG Oral CapsuleSY55e74841-23f1-4cfb-97b2-8bd2d2329b0e9
312593prazosin HCl 1 MG Oral CapsulePSN8ca758a6-df1a-4f93-8aa3-b4a36fc04bab2
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
312593prazosin 1 MG Oral CapsuleSCD8ca758a6-df1a-4f93-8aa3-b4a36fc04bab2
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 CapsuleSY8ca758a6-df1a-4f93-8aa3-b4a36fc04bab2
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
312593prazosin HCl 1 MG Oral CapsulePSN59b56b39-55f7-eb74-e053-2991aa0ae46a1
312594prazosin HCl 2 MG Oral CapsulePSN59b56b39-55f7-eb74-e053-2991aa0ae46a1
312593prazosin 1 MG Oral CapsuleSCD59b56b39-55f7-eb74-e053-2991aa0ae46a1
312594prazosin 2 MG Oral CapsuleSCD59b56b39-55f7-eb74-e053-2991aa0ae46a1
312593prazosin (as prazosin HCl) 1 MG Oral CapsuleSY59b56b39-55f7-eb74-e053-2991aa0ae46a1
312594prazosin (as prazosin HCl) 2 MG Oral CapsuleSY59b56b39-55f7-eb74-e053-2991aa0ae46a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0378-1101-0100378110101100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1101-01) 100 capsule1989-02-280000-00-00NoNoCurrent
0378-1101-10003781101101000 CAPSULE in 1 BOTTLE, PLASTIC (0378-1101-10) 1000 capsule1989-02-280000-00-00NoNoCurrent