FDA.reportPublic FDA data

Prazosin Hydrochloride

Product NDC
70518-3271
11-digit product format
705183271
Labeler code
70518
Product ID
70518-3271_4edfc77d-dec5-611b-e063-6294a90a47f8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
prazosin hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
NDA017442
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2021-11-17
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-3271-02023-03-23C16284748780-1f386c649-c010-0266-e053-dadaa90a7c1aPrazosin Hydrochloride Capsules
70518-3271-02023-01-30C16284748780-1f386c649-c010-0266-e053-dadaa90a7c1aPrazosin Hydrochloride Capsules

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-3271-0Prazosin Hydrochloride30 in 1 BOXCAPSULE307
70518-3271-1Prazosin Hydrochloride1 in 1 POUCHCAPSULE17
70518-3271-2Prazosin Hydrochloride30 in 1 BLISTER PACKCAPSULE307

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3271PRAZOSIN HYDROCHLORIDE CAPSULE [REMEDYREPACK INC.]5Current NDC, Legacy NDC, 3 package rows20240316_2f86fc8e-71c1-4749-b67e-86d86cf1d984.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312593prazosin HCl 1 MG Oral CapsulePSN2f86fc8e-71c1-4749-b67e-86d86cf1d9847
312593prazosin 1 MG Oral CapsuleSCD2f86fc8e-71c1-4749-b67e-86d86cf1d9847
312593prazosin (as prazosin HCl) 1 MG Oral CapsuleSY2f86fc8e-71c1-4749-b67e-86d86cf1d9847

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3271-07051832710030 POUCH in 1 BOX (70518-3271-0) / 1 CAPSULE in 1 POUCH (70518-3271-1) 30 pouch2021-11-170000-00-00NoNoCurrent
70518-3271-1705183271011 in 1 POUCHHistorical
70518-3271-27051832710230 in 1 BLISTER PACKHistorical