prazosin hydrochloride

Product NDC
71335-2348
11-digit product format
713352348
Labeler code
71335
Product ID
71335-2348_154dc8f2-d0aa-40ed-9209-10428725aaa4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
prazosin hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA215697
Marketing category
ANDA
Marketing start
2023-01-03
Substance
PRAZOSIN HYDROCHLORIDE
Active strength
5 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

openFDA Listing Details

Product ID
71335-2348_154dc8f2-d0aa-40ed-9209-10428725aaa4
SPL ID
154dc8f2-d0aa-40ed-9209-10428725aaa4
Product type
HUMAN PRESCRIPTION DRUG
Finished product
Yes
Brand name base
prazosin hydrochloride
Generic name
prazosin hydrochloride
Dosage form
CAPSULE
Route
ORAL
Marketing start
2023-01-03
Marketing category
ANDA
Application number
ANDA215697
Pharmacologic classes
Adrenergic alpha-Antagonists [MoA]; alpha-Adrenergic Blocker [EPC]
Listing expiration
2026-12-31

openFDA Active Ingredients

IngredientStrength
PRAZOSIN HYDROCHLORIDE5 mg/1

openFDA Harmonized Identifiers

FieldValues
UniiX0Z7454B90
Rxcui198141
Spl Set Id61e5108a-70eb-4d48-a742-defb2e918b63
Manufacturer NameBryant Ranch Prepack

openFDA Package Details

Package NDCDescriptionMarketing startSample
71335-2348-160 CAPSULE in 1 BOTTLE (71335-2348-1)2024-02-21No
71335-2348-230 CAPSULE in 1 BOTTLE (71335-2348-2)2024-02-21No

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
X0Z7454B90PRAZOSIN HYDROCHLORIDE19237-84-4PRAZOSIN HYDROCHLORIDE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2348-17133523480160 CAPSULE in 1 BOTTLE (71335-2348-1) 60 capsule2024-02-21NoNoHistorical
71335-2348-27133523480230 CAPSULE in 1 BOTTLE (71335-2348-2) 30 capsule2024-02-21NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Prazosin Hydrochloride Capsules, USPBryant Ranch Prepack2024-02-21HUMAN PRESCRIPTION DRUG LABEL100