prazosin hydrochloride

Product NDC
70518-3679
11-digit product format
705183679
Labeler code
70518
Product ID
70518-3679_507271b4-f9cc-7cbb-e063-6294a90af1ba
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
prazosin hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA215697
Marketing category
ANDA
Marketing start
2023-03-12
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
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 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
70518-3679-0prazosin hydrochloride30 in 1 BLISTER PACKCAPSULE308
70518-3679-1prazosin hydrochloride30 in 1 BLISTER PACKCAPSULE308

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3679PRAZOSIN HYDROCHLORIDE CAPSULE [REMEDYREPACK INC.]4Current NDC, 2 package rows20241013_8606d9b8-4529-4689-8c93-7114c84c2e54.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312594prazosin HCl 2 MG Oral CapsulePSN8606d9b8-4529-4689-8c93-7114c84c2e548
312594prazosin 2 MG Oral CapsuleSCD8606d9b8-4529-4689-8c93-7114c84c2e548
312594prazosin (as prazosin HCl) 2 MG Oral CapsuleSY8606d9b8-4529-4689-8c93-7114c84c2e548

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-3679-07051836790030 CAPSULE in 1 BLISTER PACK (70518-3679-0) 30 capsule2023-03-12NoNoHistorical
70518-3679-17051836790130 in 1 BLISTER PACKHistorical