FDA.reportPublic FDA data

Prazosin Hydrochloride

Product NDC
68788-8742
11-digit product format
687888742
Labeler code
68788
Product ID
68788-8742_caacb978-230c-4575-91d7-eb04ab26684f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prazosin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA210971
Marketing category
ANDA
Marketing start
2024-09-23
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
68788-8742-1Prazosin Hydrochloride100 in 1 BOTTLECAPSULE1002
68788-8742-3Prazosin Hydrochloride30 in 1 BOTTLECAPSULE302
68788-8742-6Prazosin Hydrochloride60 in 1 BOTTLECAPSULE602
68788-8742-9Prazosin Hydrochloride90 in 1 BOTTLECAPSULE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8742-1EA - Each68788-8742c0cf42b1-f18b-41a0-97f3-f7c3e75a729812024-12-10
68788-8742-3EA - Each68788-8742e8bc594e-678d-4633-839d-84d2d1939f6f12024-12-10
68788-8742-6EA - Each68788-874238a183fd-9e72-4e48-b2e6-c95e6e3114e812024-12-10
68788-8742-9EA - Each68788-8742e77dab31-3345-4526-98c2-7b3bd5bb8a0b12024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8742PRAZOSIN HYDROCHLORIDE CAPSULE [PREFERRED PHARMACEUTICALS INC.]1Current NDC, 4 package rows20240925_c4449fa8-a637-4780-8e19-51cb54e1ee68.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312594prazosin HCl 2 MG Oral CapsulePSNc4449fa8-a637-4780-8e19-51cb54e1ee682
312594prazosin 2 MG Oral CapsuleSCDc4449fa8-a637-4780-8e19-51cb54e1ee682
312594prazosin (as prazosin HCl) 2 MG Oral CapsuleSYc4449fa8-a637-4780-8e19-51cb54e1ee682

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8742-168788874201100 CAPSULE in 1 BOTTLE (68788-8742-1) 100 capsule2024-09-23NoNoCurrent
68788-8742-36878887420330 CAPSULE in 1 BOTTLE (68788-8742-3) 30 capsule2024-09-23NoNoCurrent
68788-8742-66878887420660 CAPSULE in 1 BOTTLE (68788-8742-6) 60 capsule2024-09-23NoNoCurrent
68788-8742-96878887420990 CAPSULE in 1 BOTTLE (68788-8742-9) 90 capsule2024-09-23NoNoCurrent