FDA.reportPublic FDA data

prazosin hydrochloride

Product NDC
72205-277
11-digit product format
722050277
Labeler code
72205
Product ID
72205-277_486d4f26-60ae-4e6c-aa36-0b298a7f9aed
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
prazosin hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Novadoz Pharmaceuticals LLC
Application
ANDA216727
Marketing category
ANDA
Marketing start
2024-09-17
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
72205-277-91prazosin hydrochloride100 in 1 BOTTLECAPSULE1001
72205-277-95prazosin hydrochloride250 in 1 BOTTLECAPSULE2501
72205-277-99prazosin hydrochloride1000 in 1 BOTTLECAPSULE10001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72205-277-91EA - Each72205-2776adf705a-4826-46b2-a83f-7a68598733ca12026-01-08
72205-277-95EA - Each72205-2772a36a0af-d4b3-43b3-8026-0a160cd1ceec12026-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72205-277PRAZOSIN HYDROCHLORIDE CAPSULE [NOVADOZ PHARMACEUTICALS LLC]1Current NDC, 3 package rows20250419_486d4f26-60ae-4e6c-aa36-0b298a7f9aed.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312593prazosin HCl 1 MG Oral CapsulePSN486d4f26-60ae-4e6c-aa36-0b298a7f9aed1
312594prazosin HCl 2 MG Oral CapsulePSN486d4f26-60ae-4e6c-aa36-0b298a7f9aed1
198141prazosin HCl 5 MG Oral CapsulePSN486d4f26-60ae-4e6c-aa36-0b298a7f9aed1
312593prazosin 1 MG Oral CapsuleSCD486d4f26-60ae-4e6c-aa36-0b298a7f9aed1
312594prazosin 2 MG Oral CapsuleSCD486d4f26-60ae-4e6c-aa36-0b298a7f9aed1
198141prazosin 5 MG Oral CapsuleSCD486d4f26-60ae-4e6c-aa36-0b298a7f9aed1
312593prazosin (as prazosin HCl) 1 MG Oral CapsuleSY486d4f26-60ae-4e6c-aa36-0b298a7f9aed1
312594prazosin (as prazosin HCl) 2 MG Oral CapsuleSY486d4f26-60ae-4e6c-aa36-0b298a7f9aed1
198141prazosin (as prazosin HCl) 5 MG Oral CapsuleSY486d4f26-60ae-4e6c-aa36-0b298a7f9aed1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72205-277-9172205027791100 CAPSULE in 1 BOTTLE (72205-277-91) 100 capsule2025-04-16NoNoCurrent
72205-277-9572205027795250 CAPSULE in 1 BOTTLE (72205-277-95) 250 capsule2025-04-16NoNoCurrent
72205-277-99722050277991000 CAPSULE in 1 BOTTLE (72205-277-99) 1000 capsule2025-04-16NoNoCurrent