NDC 0955-1042

Irbesartan

Irbesartan

Irbesartan is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Winthrop U.s.. The primary component is Irbesartan.

Product ID0955-1042_2985ab87-9e47-4328-9bc4-cca1972fca8b
NDC0955-1042
Product TypeHuman Prescription Drug
Proprietary NameIrbesartan
Generic NameIrbesartan
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2019-09-30
Marketing CategoryNDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
Application NumberNDA020757
Labeler NameWinthrop U.S.
Substance NameIRBESARTAN
Active Ingredient Strength300 mg/1
Pharm ClassesAngiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0955-1042-90

90 TABLET, FILM COATED in 1 BOTTLE (0955-1042-90)
Marketing Start Date2019-09-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0955-1042-30 [00955104230]

Irbesartan TABLET, FILM COATED
Marketing CategoryNDA AUTHORIZED GENERIC
Application NumberNDA020757
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-09-30
Marketing End Date2019-08-08

NDC 0955-1042-05 [00955104205]

Irbesartan TABLET, FILM COATED
Marketing CategoryNDA AUTHORIZED GENERIC
Application NumberNDA020757
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-09-30
Marketing End Date2013-01-02

NDC 0955-1042-90 [00955104290]

Irbesartan TABLET, FILM COATED
Marketing CategoryNDA AUTHORIZED GENERIC
Application NumberNDA020757
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-09-30

Drug Details

Active Ingredients

IngredientStrength
IRBESARTAN300 mg/1

OpenFDA Data

SPL SET ID:8c5a4a2a-234e-4702-9ba0-844ea86ec8b9
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 200096
  • 200095
  • 200094
  • Pharmacological Class

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

    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.