Doxazosin Mesylate

Product NDC
53747-352
11-digit product format
537470352
Labeler code
53747
Product ID
53747-352_761d3af7-ac26-462c-a5a0-0435f782bd62
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxazosin Mesylate
Dosage form
TABLET
Route
ORAL
Labeler
Unichem Laboratories Limited, India
Application
ANDA212329
Marketing category
ANDA
Marketing start
2024-01-10
Substance
DOXAZOSIN MESYLATE
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

openFDA Listing Details

Product ID
53747-352_761d3af7-ac26-462c-a5a0-0435f782bd62
SPL ID
761d3af7-ac26-462c-a5a0-0435f782bd62
Product type
HUMAN PRESCRIPTION DRUG
Finished product
Yes
Brand name base
Doxazosin Mesylate
Generic name
Doxazosin Mesylate
Dosage form
TABLET
Route
ORAL
Marketing start
2024-01-10
Marketing category
ANDA
Application number
ANDA212329
Pharmacologic classes
Adrenergic alpha-Antagonists [MoA]; alpha-Adrenergic Blocker [EPC]
Listing expiration
2026-12-31

openFDA Active Ingredients

IngredientStrength
DOXAZOSIN MESYLATE2 mg/1

openFDA Package Details

Package NDCDescriptionMarketing startSample
53747-352-01100 TABLET in 1 BOTTLE (53747-352-01)2024-03-15No
53747-352-101000 TABLET in 1 BOTTLE (53747-352-10)2024-03-15No
53747-352-1330 TABLET in 1 BOTTLE (53747-352-13)2024-03-15No

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
86P6PQK0MUDOXAZOSIN MESYLATE77883-43-3DOXAZOSIN MESYLATE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
53747-352-0153747035201100 TABLET in 1 BOTTLE (53747-352-01) 100 tablet2024-03-15NoNoHistorical
53747-352-10537470352101000 TABLET in 1 BOTTLE (53747-352-10) 1000 tablet2024-03-15NoNoHistorical
53747-352-135374703521330 TABLET in 1 BOTTLE (53747-352-13) 30 tablet2024-03-15NoNoHistorical