NDC 33342-049

Irbesartan

Irbesartan

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

Product ID33342-049_03835f24-83b5-40ce-bd54-3b16fb2a8794
NDC33342-049
Product TypeHuman Prescription Drug
Proprietary NameIrbesartan
Generic NameIrbesartan
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2012-09-27
Marketing CategoryANDA / ANDA
Application NumberANDA202254
Labeler NameMacleods Pharmaceuticals Limited
Substance NameIRBESARTAN
Active Ingredient Strength300 mg/1
Pharm ClassesAngiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 33342-049-07

30 TABLET in 1 BOTTLE (33342-049-07)
Marketing Start Date2012-09-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 33342-049-07 [33342004907]

Irbesartan TABLET
Marketing CategoryANDA
Application NumberANDA202254
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-09-27

NDC 33342-049-10 [33342004910]

Irbesartan TABLET
Marketing CategoryANDA
Application NumberANDA202254
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-03-11

NDC 33342-049-15 [33342004915]

Irbesartan TABLET
Marketing CategoryANDA
Application NumberANDA202254
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-09-27

NDC 33342-049-39 [33342004939]

Irbesartan TABLET
Marketing CategoryANDA
Application NumberANDA202254
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-09-27

NDC 33342-049-76 [33342004976]

Irbesartan TABLET
Marketing CategoryANDA
Application NumberANDA202254
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-02-26

Drug Details

Active Ingredients

IngredientStrength
IRBESARTAN300 mg/1

OpenFDA Data

SPL SET ID:e8635a1c-ae06-4e23-99f7-e704f91d6f43
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 200096
  • 200095
  • 200094
    • UPC Code
  • 0333342048653
  • 0333342049100
  • 0333342048103
  • 0333342047151
  • 0333342047687
  • 0333342049766
  • 0333342048073
  • 0333342048158
  • 0333342049070
  • 0333342047106

    • Pharmacological Class

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

    Medicade Reported Pricing

    33342004910 IRBESARTAN 300 MG TABLET

    Pricing Unit: EA | Drug Type:

    33342004907 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.