FDA.reportPublic FDA data

prazosin hydrochloride

Product NDC
68788-8660
11-digit product format
687888660
Labeler code
68788
Product ID
68788-8660_d1a352ae-3540-4e47-aba3-4507dd872b6b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
prazosin hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA215697
Marketing category
ANDA
Marketing start
2024-05-13
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
68788-8660-1prazosin hydrochloride100 in 1 BOTTLECAPSULE1002
68788-8660-3prazosin hydrochloride30 in 1 BOTTLECAPSULE302
68788-8660-6prazosin hydrochloride60 in 1 BOTTLECAPSULE602
68788-8660-9prazosin hydrochloride90 in 1 BOTTLECAPSULE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8660-1EA - Each68788-866030671997-39fb-4f3b-a25c-45bbdb1d614012024-07-12
68788-8660-3EA - Each68788-8660651a86ca-9feb-4be6-ba38-22780414717c12024-07-12
68788-8660-6EA - Each68788-866072048968-4a8e-4ca9-a82b-3469a2f31d9212024-07-12
68788-8660-9EA - Each68788-866003229a45-935b-4477-9c86-6519852db23e12024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8660PRAZOSIN HYDROCHLORIDE CAPSULE [PREFERRED PHARMACEUTICALS INC.]1Current NDC, 4 package rows20240531_e5bd5728-ea7c-4f16-832b-8d58fe14b994.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198141prazosin HCl 5 MG Oral CapsulePSNe5bd5728-ea7c-4f16-832b-8d58fe14b9942
198141prazosin 5 MG Oral CapsuleSCDe5bd5728-ea7c-4f16-832b-8d58fe14b9942
198141prazosin (as prazosin HCl) 5 MG Oral CapsuleSYe5bd5728-ea7c-4f16-832b-8d58fe14b9942

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8660-168788866001100 CAPSULE in 1 BOTTLE (68788-8660-1) 100 capsule2024-05-13NoNoCurrent
68788-8660-36878886600330 CAPSULE in 1 BOTTLE (68788-8660-3) 30 capsule2024-05-13NoNoCurrent
68788-8660-66878886600660 CAPSULE in 1 BOTTLE (68788-8660-6) 60 capsule2024-05-13NoNoCurrent
68788-8660-96878886600990 CAPSULE in 1 BOTTLE (68788-8660-9) 90 capsule2024-05-13NoNoCurrent