Prazosin hydrochloride

Product NDC
70518-4263
11-digit product format
705184263
Labeler code
70518
Product ID
70518-4263_4009c02d-01f9-3a17-e063-6294a90aece1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prazosin hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA213406
Marketing category
ANDA
Marketing start
2025-01-23
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
70518-4263-0Prazosin hydrochloride30 in 1 BLISTER PACKCAPSULE302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-4263PRAZOSIN HYDROCHLORIDE CAPSULE [REMEDYREPACK INC.]1Current NDC, 1 package rows20250125_b55790fa-2413-4243-83ec-0391b2effe11.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312594prazosin HCl 2 MG Oral CapsulePSNb55790fa-2413-4243-83ec-0391b2effe112
312594prazosin 2 MG Oral CapsuleSCDb55790fa-2413-4243-83ec-0391b2effe112
312594prazosin (as prazosin HCl) 2 MG Oral CapsuleSYb55790fa-2413-4243-83ec-0391b2effe112

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-4263-07051842630030 CAPSULE in 1 BLISTER PACK (70518-4263-0) 30 capsule2025-01-23NoNoHistorical