Prazosin Hydrochloride

Product NDC
0615-8519
11-digit product format
006158519
Labeler code
0615
Product ID
0615-8519_86d3c997-3449-46f4-8bc9-1805c5255e04
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prazosin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
NCS HealthCare of KY, LLC dba Vangard Labs
Application
ANDA210971
Marketing category
ANDA
Marketing start
2018-10-03
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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PRAZOSIN HYDROCHLORIDE1 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX0Z7454B90

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
0615-8519-39Prazosin Hydrochloride30 in 1 BLISTER PACKCAPSULE302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0615-8519PRAZOSIN HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS]2Current NDC, 1 package rows20241004_511b4409-7273-4b74-ae55-47c97f0c3ea4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312593prazosin HCl 1 MG Oral CapsulePSN511b4409-7273-4b74-ae55-47c97f0c3ea42
312594prazosin HCl 2 MG Oral CapsulePSN511b4409-7273-4b74-ae55-47c97f0c3ea42
312593prazosin 1 MG Oral CapsuleSCD511b4409-7273-4b74-ae55-47c97f0c3ea42
312594prazosin 2 MG Oral CapsuleSCD511b4409-7273-4b74-ae55-47c97f0c3ea42
312593prazosin (as prazosin HCl) 1 MG Oral CapsuleSY511b4409-7273-4b74-ae55-47c97f0c3ea42
312594prazosin (as prazosin HCl) 2 MG Oral CapsuleSY511b4409-7273-4b74-ae55-47c97f0c3ea42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0615-8519-390061585193930 CAPSULE in 1 BLISTER PACK (0615-8519-39) 30 capsule2024-08-13NoNoCurrent