NDC 68382-300

Irbesartan

Irbesartan

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

Product ID68382-300_3d8cb010-c629-4de6-9bb1-caaa7463e37c
NDC68382-300
Product TypeHuman Prescription Drug
Proprietary NameIrbesartan
Generic NameIrbesartan
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2017-12-08
Marketing CategoryANDA / ANDA
Application NumberANDA079213
Labeler NameZydus Pharmaceuticals USA Inc.
Substance NameIRBESARTAN
Active Ingredient Strength150 mg/1
Pharm ClassesAngiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 68382-300-05

500 TABLET in 1 BOTTLE (68382-300-05)
Marketing Start Date2017-12-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68382-300-30 [68382030030]

Irbesartan TABLET
Marketing CategoryANDA
Application NumberANDA079213
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-12-08

NDC 68382-300-77 [68382030077]

Irbesartan TABLET
Marketing CategoryANDA
Application NumberANDA079213
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-12-08

NDC 68382-300-10 [68382030010]

Irbesartan TABLET
Marketing CategoryANDA
Application NumberANDA079213
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-12-08

NDC 68382-300-06 [68382030006]

Irbesartan TABLET
Marketing CategoryANDA
Application NumberANDA079213
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-12-08

NDC 68382-300-16 [68382030016]

Irbesartan TABLET
Marketing CategoryANDA
Application NumberANDA079213
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-12-08

NDC 68382-300-05 [68382030005]

Irbesartan TABLET
Marketing CategoryANDA
Application NumberANDA079213
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-12-08

Drug Details

Active Ingredients

IngredientStrength
IRBESARTAN150 mg/1

OpenFDA Data

SPL SET ID:f0928804-040e-400b-ace6-cfe432cec547
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 200096
  • 200095
  • 200094
    • UPC Code
  • 0368382299109
  • 0368382300102
  • 0368382301109

    • 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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