FDA.reportPublic FDA data

PRAZOSIN HYDROCHLORIDE

Product NDC
62332-692
11-digit product format
623320692
Labeler code
62332
Product ID
62332-692_c8142eb6-b8f8-4db8-9f60-0197c908d85a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PRAZOSIN HYDROCHLORIDE
Dosage form
CAPSULE
Route
ORAL
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA217268
Marketing category
ANDA
Marketing start
2023-03-09
Substance
PRAZOSIN HYDROCHLORIDE
Active strength
2 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 HYDROCHLORIDE2 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
62332-692-31PRAZOSIN HYDROCHLORIDE100 in 1 BOTTLECAPSULE1005
62332-692-61PRAZOSIN HYDROCHLORIDE250 in 1 BOTTLECAPSULE2505
62332-692-91PRAZOSIN HYDROCHLORIDE1000 in 1 BOTTLECAPSULE10005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-692PRAZOSIN HYDROCHLORIDE CAPSULE [ALEMBIC PHARMACEUTICALS INC.]5Current NDC, 3 package rows20230517_d4af73d1-c97e-4418-9e24-007b10af0bd9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312593prazosin HCl 1 MG Oral CapsulePSNd4af73d1-c97e-4418-9e24-007b10af0bd95
312594prazosin HCl 2 MG Oral CapsulePSNd4af73d1-c97e-4418-9e24-007b10af0bd95
198141prazosin HCl 5 MG Oral CapsulePSNd4af73d1-c97e-4418-9e24-007b10af0bd95
312593prazosin 1 MG Oral CapsuleSCDd4af73d1-c97e-4418-9e24-007b10af0bd95
312594prazosin 2 MG Oral CapsuleSCDd4af73d1-c97e-4418-9e24-007b10af0bd95
198141prazosin 5 MG Oral CapsuleSCDd4af73d1-c97e-4418-9e24-007b10af0bd95
312593prazosin (as prazosin HCl) 1 MG Oral CapsuleSYd4af73d1-c97e-4418-9e24-007b10af0bd95
312594prazosin (as prazosin HCl) 2 MG Oral CapsuleSYd4af73d1-c97e-4418-9e24-007b10af0bd95
198141prazosin (as prazosin HCl) 5 MG Oral CapsuleSYd4af73d1-c97e-4418-9e24-007b10af0bd95

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62332-692-3162332069231100 CAPSULE in 1 BOTTLE (62332-692-31) 100 capsule2023-03-09NoNoCurrent
62332-692-6162332069261250 CAPSULE in 1 BOTTLE (62332-692-61) 250 capsule2023-03-09NoNoCurrent
62332-692-91623320692911000 CAPSULE in 1 BOTTLE (62332-692-91) 1000 capsule2023-03-09NoNoCurrent