FDA.reportPublic FDA data

Prazosin Hydrochloride

Product NDC
60687-572
11-digit product format
606870572
Labeler code
60687
Product ID
60687-572_2b330558-e654-74d6-e063-6394a90a9fd0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prazosin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
American Health Packaging
Application
ANDA071745
Marketing category
ANDA
Marketing start
2021-04-21
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

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
60687-572-32Prazosin Hydrochloride20 in 1 BOX, UNIT-DOSECAPSULE204
60687-572-33Prazosin Hydrochloride1 in 1 BLISTER PACKCAPSULE14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-572-32EA - Each60687-5726a8540b7-0a6d-4a00-baca-dbb3c4f22a0612021-04-08
60687-572-33EA - Each60687-57281830ae6-8aa1-4c21-b808-910deb936b9512021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-572PRAZOSIN HYDROCHLORIDE CAPSULE [AMERICAN HEALTH PACKAGING]4Current NDC, Legacy NDC, 2 package rows20250110_a2b84746-f780-4e21-adc9-62d09c9363cf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198141prazosin HCl 5 MG Oral CapsulePSNa2b84746-f780-4e21-adc9-62d09c9363cf4
198141prazosin 5 MG Oral CapsuleSCDa2b84746-f780-4e21-adc9-62d09c9363cf4
198141prazosin (as prazosin HCl) 5 MG Oral CapsuleSYa2b84746-f780-4e21-adc9-62d09c9363cf4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-572-326068705723220 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-572-32) / 1 CAPSULE in 1 BLISTER PACK (60687-572-33) 20 blister pack2021-04-210000-00-00NoNoCurrent
60687-572-33606870572331 in 1 BLISTER PACKHistorical