FDA.reportPublic FDA data

Prazosin Hydrochloride

Product NDC
76282-721
11-digit product format
762820721
Labeler code
76282
Product ID
76282-721_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
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
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PRAZOSIN HYDROCHLORIDE1 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
76282-721-01Prazosin Hydrochloride100 in 1 BOTTLECAPSULE1002
76282-721-10Prazosin Hydrochloride1000 in 1 BOTTLECAPSULE10002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76282-721-01EA - Each76282-7218b35a03c-03a1-4dff-9285-91944a81a69a12023-02-06
76282-721-10EA - Each76282-7218520eeb9-0814-4127-adde-e020dc24032412023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76282-721PRAZOSIN 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
312593prazosin HCl 1 MG Oral CapsulePSNd33bb132-1b5f-44a2-bc42-e9201cb6566a1
312594prazosin HCl 2 MG Oral CapsulePSNd33bb132-1b5f-44a2-bc42-e9201cb6566a1
312593prazosin 1 MG Oral CapsuleSCDd33bb132-1b5f-44a2-bc42-e9201cb6566a1
312594prazosin 2 MG Oral CapsuleSCDd33bb132-1b5f-44a2-bc42-e9201cb6566a1
312593prazosin (as prazosin HCl) 1 MG Oral CapsuleSYd33bb132-1b5f-44a2-bc42-e9201cb6566a1
312594prazosin (as prazosin HCl) 2 MG Oral CapsuleSYd33bb132-1b5f-44a2-bc42-e9201cb6566a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76282-721-0176282072101100 CAPSULE in 1 BOTTLE (76282-721-01) 100 capsule2023-01-17NoNoHistorical
76282-721-10762820721101000 CAPSULE in 1 BOTTLE (76282-721-10) 1000 capsule2023-01-17NoNoHistorical