Prazosin hydrochloride

Product NDC
70518-3928
11-digit product format
705183928
Labeler code
70518
Product ID
70518-3928_3bb15529-98fe-fc88-e063-6294a90a4a30
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prazosin hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA213406
Marketing category
ANDA
Marketing start
2023-11-29
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
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 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
70518-3928-0Prazosin hydrochloride30 in 1 BLISTER PACKCAPSULE305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3928PRAZOSIN HYDROCHLORIDE CAPSULE [REMEDYREPACK INC.]4Current NDC, 1 package rows20250124_960f4d8d-6683-44ff-a3a7-e0f922e621b9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312593prazosin HCl 1 MG Oral CapsulePSN960f4d8d-6683-44ff-a3a7-e0f922e621b95
312593prazosin 1 MG Oral CapsuleSCD960f4d8d-6683-44ff-a3a7-e0f922e621b95
312593prazosin (as prazosin HCl) 1 MG Oral CapsuleSY960f4d8d-6683-44ff-a3a7-e0f922e621b95

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-3928-07051839280030 CAPSULE in 1 BLISTER PACK (70518-3928-0) 30 capsule2023-11-29NoNoCurrent