NDC 46708-441

IRBESARTAN

Irbesartan

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

Product ID46708-441_0898f423-0aa9-409c-8d4e-1349b59141d1
NDC46708-441
Product TypeHuman Prescription Drug
Proprietary NameIRBESARTAN
Generic NameIrbesartan
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2016-07-01
Marketing CategoryANDA / ANDA
Application NumberANDA091236
Labeler NameAlembic 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 Through2019-12-31

Packaging

NDC 46708-441-30

30 TABLET in 1 BOTTLE (46708-441-30)
Marketing Start Date2016-07-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 46708-441-91 [46708044191]

IRBESARTAN TABLET
Marketing CategoryANDA
Application NumberANDA091236
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-07-01

NDC 46708-441-30 [46708044130]

IRBESARTAN TABLET
Marketing CategoryANDA
Application NumberANDA091236
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-07-01

NDC 46708-441-71 [46708044171]

IRBESARTAN TABLET
Marketing CategoryANDA
Application NumberANDA091236
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-07-01

NDC 46708-441-31 [46708044131]

IRBESARTAN TABLET
Marketing CategoryANDA
Application NumberANDA091236
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-07-01

NDC 46708-441-90 [46708044190]

IRBESARTAN TABLET
Marketing CategoryANDA
Application NumberANDA091236
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-07-01

Drug Details

Active Ingredients

IngredientStrength
IRBESARTAN300 mg/1

OpenFDA Data

SPL SET ID:0898f423-0aa9-409c-8d4e-1349b59141d1
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 200096
  • 200095
  • 200094
    • UPC Code
  • 0346708441302
  • 0346708440305
  • 0346708439309

    • 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
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