NDC 69367-121

Irbesartan

Irbesartan

Irbesartan is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Westminster Pharmaceuticals, Llc. The primary component is Irbesartan.

Product ID69367-121_2aba2a7a-306f-3711-e054-00144ff88e88
NDC69367-121
Product TypeHuman Prescription Drug
Proprietary NameIrbesartan
Generic NameIrbesartan
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2016-02-01
Marketing CategoryANDA / ANDA
Application NumberANDA204774
Labeler NameWestminster Pharmaceuticals, LLC
Substance NameIRBESARTAN
Active Ingredient Strength300 mg/300mg
Pharm ClassesAngiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 69367-121-01

30 mg in 1 BOTTLE (69367-121-01)
Marketing Start Date2016-02-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69367-121-03 [69367012103]

Irbesartan TABLET
Marketing CategoryANDA
Application NumberANDA204774
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-02-01

NDC 69367-121-01 [69367012101]

Irbesartan TABLET
Marketing CategoryANDA
Application NumberANDA204774
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-02-01

Drug Details

Active Ingredients

IngredientStrength
IRBESARTAN300 mg/300mg

OpenFDA Data

SPL SET ID:2a7cc4e3-bf9e-6d21-e054-00144ff8d46c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 200096
  • 200095
  • 200094
  • UPC Code
  • 0369367119030
  • 0369367121033
  • 0369367121019
  • 0369367119016
  • 0369367120036
  • 0369367120012
  • Pharmacological Class

    • Angiotensin 2 Receptor Antagonists [MoA]
    • Angiotensin 2 Receptor Blocker [EPC]

    Medicade Reported Pricing

    69367012103 IRBESARTAN 300 MG TABLET

    Pricing Unit: EA | Drug Type:

    69367012101 IRBESARTAN 300 MG TABLET

    Pricing Unit: EA | Drug Type:

    NDC Crossover Matching brand name "Irbesartan" or generic name "Irbesartan"

    NDCBrand NameGeneric Name
    0054-0250IrbesartanIrbesartan
    0054-0251IrbesartanIrbesartan
    0054-0252IrbesartanIrbesartan
    0955-1040Irbesartanirbesartan
    0955-1041Irbesartanirbesartan
    0955-1042Irbesartanirbesartan
    68084-217IrbesartanIrbesartan
    68180-410IrbesartanIrbesartan
    68180-412IrbesartanIrbesartan
    68180-411IrbesartanIrbesartan
    68382-300IrbesartanIrbesartan
    68382-299IrbesartanIrbesartan
    68382-301IrbesartanIrbesartan
    69367-120IrbesartanIrbesartan
    69367-121IrbesartanIrbesartan
    69367-119IrbesartanIrbesartan
    70518-1543IrbesartanIrbesartan
    70518-1328IrbesartanIrbesartan
    70518-1329IrbesartanIrbesartan
    70518-1974IRBESARTANIRBESARTAN
    70518-1798IrbesartanIrbesartan
    70518-1690IrbesartanIrbesartan
    70771-1161IrbesartanIrbesartan
    70771-1160IrbesartanIrbesartan
    70771-1159IrbesartanIrbesartan
    71335-0071IrbesartanIrbesartan
    71205-082IrbesartanIrbesartan
    71335-0423IRBESARTANIRBESARTAN
    29300-214IrbesartanIrbesartan
    29300-213IrbesartanIrbesartan
    27241-035IrbesartanIrbesartan
    29300-212IrbesartanIrbesartan
    27241-033IrbesartanIrbesartan
    27241-036IrbesartanIrbesartan
    31722-162IrbesartanIrbesartan
    31722-160IrbesartanIrbesartan
    31722-729IrbesartanIrbesartan
    31722-730IrbesartanIrbesartan
    33342-049IrbesartanIrbesartan
    33342-047IrbesartanIrbesartan
    33342-048IrbesartanIrbesartan
    31722-161IrbesartanIrbesartan
    31722-731IrbesartanIrbesartan
    42658-122IRBESARTANIRBESARTAN
    42658-121IRBESARTANIRBESARTAN
    42658-123IRBESARTANIRBESARTAN
    43547-374IrbesartanIrbesartan
    43547-375IrbesartanIrbesartan
    43547-279IrbesartanIrbesartan
    43547-277IrbesartanIrbesartan

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.