Prazosin Hydrochloride

Product NDC
70518-4457
11-digit product format
705184457
Labeler code
70518
Product ID
70518-4457_4af0abd0-77a6-d9c5-e063-6294a90a5499
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prazosin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA210971
Marketing category
ANDA
Marketing start
2025-08-26
Substance
PRAZOSIN HYDROCHLORIDE
Active strength
1 mg/1
Pharmacologic classes
Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Prazosin Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PRAZOSIN HYDROCHLORIDE1 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX0Z7454B90
Rxcui312593

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
70518-4457-0Prazosin Hydrochloride30 in 1 BLISTER PACKCAPSULE303
70518-4457-1Prazosin Hydrochloride30 in 1 BLISTER PACKCAPSULE303

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312593prazosin HCl 1 MG Oral CapsulePSNfd860756-9b2e-4bfd-9063-bc4d26366fe63
312593prazosin 1 MG Oral CapsuleSCDfd860756-9b2e-4bfd-9063-bc4d26366fe63
312593prazosin (as prazosin HCl) 1 MG Oral CapsuleSYfd860756-9b2e-4bfd-9063-bc4d26366fe63

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-4457-07051844570030 CAPSULE in 1 BLISTER PACK (70518-4457-0) 30 capsule2025-08-26NoNoHistorical
70518-4457-17051844570130 CAPSULE in 1 BLISTER PACK (70518-4457-1) 30 capsule2026-02-15NoNoHistorical