prazosin hydrochloride

Product NDC
70518-4288
11-digit product format
705184288
Labeler code
70518
Product ID
70518-4288_401bc402-25db-befa-e063-6394a90a5424
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
prazosin hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA215697
Marketing category
ANDA
Marketing start
2025-02-13
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
70518-4288-0prazosin hydrochloride30 in 1 BLISTER PACKCAPSULE302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-4288PRAZOSIN HYDROCHLORIDE (PRAZOSIN HYDROCHLORIDE) CAPSULE [REMEDYREPACK INC.]1Current NDC, 1 package rows20250215_e4852fc2-b763-40e2-b8bb-a3f6da5c72fe.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198141prazosin HCl 5 MG Oral CapsulePSNe4852fc2-b763-40e2-b8bb-a3f6da5c72fe2
198141prazosin 5 MG Oral CapsuleSCDe4852fc2-b763-40e2-b8bb-a3f6da5c72fe2
198141prazosin (as prazosin HCl) 5 MG Oral CapsuleSYe4852fc2-b763-40e2-b8bb-a3f6da5c72fe2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-4288-07051842880030 CAPSULE in 1 BLISTER PACK (70518-4288-0) 30 capsule2025-02-13NoNoHistorical