FDA.reportPublic FDA data

Prazosin Hydrochloride

Product NDC
59651-273
11-digit product format
596510273
Labeler code
59651
Product ID
59651-273_08114092-fa12-4f58-b08e-03cadf9f726b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prazosin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA213052
Marketing category
ANDA
Marketing start
2023-03-31
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
59651-273-01Prazosin Hydrochloride100 in 1 BOTTLECAPSULE1001
59651-273-25Prazosin Hydrochloride250 in 1 BOTTLECAPSULE2501

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-273-01EA - Each59651-2736a9ad717-151c-4d25-aac6-d8ff671c6d7012024-02-14
59651-273-25EA - Each59651-273a54b1dd5-5d81-4cfe-86d4-8d0e27ff1ba112024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-273PRAZOSIN HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]1Current NDC, 2 package rows20230412_08114092-fa12-4f58-b08e-03cadf9f726b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312593prazosin HCl 1 MG Oral CapsulePSN08114092-fa12-4f58-b08e-03cadf9f726b1
312594prazosin HCl 2 MG Oral CapsulePSN08114092-fa12-4f58-b08e-03cadf9f726b1
198141prazosin HCl 5 MG Oral CapsulePSN08114092-fa12-4f58-b08e-03cadf9f726b1
198141prazosin HCl 5 MG Oral CapsulePSN52ce82b0-3cb5-b5b2-e063-6394a90a9f121
312593prazosin 1 MG Oral CapsuleSCD08114092-fa12-4f58-b08e-03cadf9f726b1
312594prazosin 2 MG Oral CapsuleSCD08114092-fa12-4f58-b08e-03cadf9f726b1
198141prazosin 5 MG Oral CapsuleSCD08114092-fa12-4f58-b08e-03cadf9f726b1
198141prazosin 5 MG Oral CapsuleSCD52ce82b0-3cb5-b5b2-e063-6394a90a9f121
312593prazosin (as prazosin HCl) 1 MG Oral CapsuleSY08114092-fa12-4f58-b08e-03cadf9f726b1
312594prazosin (as prazosin HCl) 2 MG Oral CapsuleSY08114092-fa12-4f58-b08e-03cadf9f726b1
198141prazosin (as prazosin HCl) 5 MG Oral CapsuleSY08114092-fa12-4f58-b08e-03cadf9f726b1
198141prazosin (as prazosin HCl) 5 MG Oral CapsuleSY52ce82b0-3cb5-b5b2-e063-6394a90a9f121

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59651-273-0159651027301100 CAPSULE in 1 BOTTLE (59651-273-01) 100 capsule2023-03-31NoNoCurrent
59651-273-2559651027325250 CAPSULE in 1 BOTTLE (59651-273-25) 250 capsule2023-03-31NoNoCurrent