FDA.reportPublic FDA data

prazosin hydrochloride

Product NDC
71335-2311
11-digit product format
713352311
Labeler code
71335
Product ID
71335-2311_35e8bed8-5ae3-4985-9691-e6861194c82d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
prazosin hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA215697
Marketing category
ANDA
Marketing start
2023-01-03
Substance
PRAZOSIN HYDROCHLORIDE
Active strength
2 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 HYDROCHLORIDE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX0Z7454B90
Rxcui312594

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
71335-2311-1prazosin hydrochloride30 in 1 BOTTLECAPSULE30100
71335-2311-2prazosin hydrochloride28 in 1 BOTTLECAPSULE28100
71335-2311-3prazosin hydrochloride60 in 1 BOTTLECAPSULE60100
71335-2311-4prazosin hydrochloride90 in 1 BOTTLECAPSULE90100
71335-2311-5prazosin hydrochloride18 in 1 BOTTLECAPSULE18100

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2311-1EA - Each71335-23116e2c2349-c583-4e8b-8366-cb1f053e057812025-05-14
71335-2311-4EA - Each71335-2311a1853198-6c84-4411-a9d3-360019e3fb8d12025-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2311PRAZOSIN HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]100Current NDC, 5 package rows20231222_f475c5e7-94df-40c8-b35f-ce6f866ed1b9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312594prazosin HCl 2 MG Oral CapsulePSNf475c5e7-94df-40c8-b35f-ce6f866ed1b9100
312594prazosin 2 MG Oral CapsuleSCDf475c5e7-94df-40c8-b35f-ce6f866ed1b9100
312594prazosin (as prazosin HCl) 2 MG Oral CapsuleSYf475c5e7-94df-40c8-b35f-ce6f866ed1b9100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2311-17133523110130 CAPSULE in 1 BOTTLE (71335-2311-1) 30 capsule2023-12-21NoNoHistorical
71335-2311-27133523110228 CAPSULE in 1 BOTTLE (71335-2311-2) 28 capsule2023-12-21NoNoHistorical
71335-2311-37133523110360 CAPSULE in 1 BOTTLE (71335-2311-3) 60 capsule2023-12-21NoNoHistorical
71335-2311-47133523110490 CAPSULE in 1 BOTTLE (71335-2311-4) 90 capsule2023-12-21NoNoHistorical
71335-2311-57133523110518 CAPSULE in 1 BOTTLE (71335-2311-5) 18 capsule2023-12-21NoNoHistorical