FDA.reportPublic FDA data

PRAZOSIN HYDROCHLORIDE

Product NDC
46708-692
11-digit product format
467080692
Labeler code
46708
Product ID
46708-692_fea187a3-ee8b-4463-8485-3b1de1504609
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PRAZOSIN HYDROCHLORIDE
Dosage form
CAPSULE
Route
ORAL
Labeler
Alembic Pharmaceuticals Limited
Application
ANDA217268
Marketing category
ANDA
Marketing start
2023-03-09
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
Rxcui198141, 312593, 312594

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
46708-692-31PRAZOSIN HYDROCHLORIDE100 in 1 BOTTLECAPSULE1001
46708-692-61PRAZOSIN HYDROCHLORIDE250 in 1 BOTTLECAPSULE2501
46708-692-91PRAZOSIN HYDROCHLORIDE1000 in 1 BOTTLECAPSULE10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46708-692PRAZOSIN HYDROCHLORIDE CAPSULE [ALEMBIC PHARMACEUTICALS LIMITED]1Current NDC, 3 package rows20230315_fea187a3-ee8b-4463-8485-3b1de1504609.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312593prazosin HCl 1 MG Oral CapsulePSNfea187a3-ee8b-4463-8485-3b1de15046091
312594prazosin HCl 2 MG Oral CapsulePSNfea187a3-ee8b-4463-8485-3b1de15046091
198141prazosin HCl 5 MG Oral CapsulePSNfea187a3-ee8b-4463-8485-3b1de15046091
312593prazosin 1 MG Oral CapsuleSCDfea187a3-ee8b-4463-8485-3b1de15046091
312594prazosin 2 MG Oral CapsuleSCDfea187a3-ee8b-4463-8485-3b1de15046091
198141prazosin 5 MG Oral CapsuleSCDfea187a3-ee8b-4463-8485-3b1de15046091
312593prazosin (as prazosin HCl) 1 MG Oral CapsuleSYfea187a3-ee8b-4463-8485-3b1de15046091
312594prazosin (as prazosin HCl) 2 MG Oral CapsuleSYfea187a3-ee8b-4463-8485-3b1de15046091
198141prazosin (as prazosin HCl) 5 MG Oral CapsuleSYfea187a3-ee8b-4463-8485-3b1de15046091

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
46708-692-3146708069231100 CAPSULE in 1 BOTTLE (46708-692-31) 100 capsule2023-03-09NoNoCurrent
46708-692-6146708069261250 CAPSULE in 1 BOTTLE (46708-692-61) 250 capsule2023-03-09NoNoCurrent
46708-692-91467080692911000 CAPSULE in 1 BOTTLE (46708-692-91) 1000 capsule2023-03-09NoNoCurrent