FDA.reportPublic FDA data

Prazosin Hydrochloride

Product NDC
76282-723
11-digit product format
762820723
Labeler code
76282
Product ID
76282-723_f3388e9a-2c36-de8d-e053-2a95a90aa213
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prazosin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Exelan Pharmaceuticals
Application
ANDA214608
Marketing category
ANDA
Marketing start
2023-01-17
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
76282-723-01Prazosin Hydrochloride100 in 1 BOTTLECAPSULE1002
76282-723-25Prazosin Hydrochloride250 in 1 BOTTLECAPSULE2502

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76282-723-01EA - Each76282-7236c6208a9-a420-4558-ae7f-af7a0be4ebc912023-02-06
76282-723-25EA - Each76282-72386d1c157-32ef-4522-aec5-77b94682f3fb12023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76282-723PRAZOSIN HYDROCHLORIDE CAPSULE [EXELAN PHARMACEUTICALS]2Current NDC, 2 package rows20230129_cdde7b22-6b29-4cac-8bd6-f613dab6eef1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312593prazosin HCl 1 MG Oral CapsulePSNcdde7b22-6b29-4cac-8bd6-f613dab6eef12
312594prazosin HCl 2 MG Oral CapsulePSNcdde7b22-6b29-4cac-8bd6-f613dab6eef12
198141prazosin HCl 5 MG Oral CapsulePSNcdde7b22-6b29-4cac-8bd6-f613dab6eef12
312593prazosin 1 MG Oral CapsuleSCDcdde7b22-6b29-4cac-8bd6-f613dab6eef12
312594prazosin 2 MG Oral CapsuleSCDcdde7b22-6b29-4cac-8bd6-f613dab6eef12
198141prazosin 5 MG Oral CapsuleSCDcdde7b22-6b29-4cac-8bd6-f613dab6eef12
312593prazosin (as prazosin HCl) 1 MG Oral CapsuleSYcdde7b22-6b29-4cac-8bd6-f613dab6eef12
312594prazosin (as prazosin HCl) 2 MG Oral CapsuleSYcdde7b22-6b29-4cac-8bd6-f613dab6eef12
198141prazosin (as prazosin HCl) 5 MG Oral CapsuleSYcdde7b22-6b29-4cac-8bd6-f613dab6eef12
198141prazosin HCl 5 MG Oral CapsulePSN18680157-a123-1072-e063-6394a90ad5ef1
198141prazosin 5 MG Oral CapsuleSCD18680157-a123-1072-e063-6394a90ad5ef1
198141prazosin (as prazosin HCl) 5 MG Oral CapsuleSY18680157-a123-1072-e063-6394a90ad5ef1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76282-723-0176282072301100 CAPSULE in 1 BOTTLE (76282-723-01) 100 capsule2023-01-17NoNoCurrent
76282-723-2576282072325250 CAPSULE in 1 BOTTLE (76282-723-25) 250 capsule2023-01-17NoNoCurrent