NDC 57297-412

Irbesartan

Irbesartan

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

Product ID57297-412_d68faa18-807b-4fc0-808f-b00378a68a41
NDC57297-412
Product TypeHuman Prescription Drug
Proprietary NameIrbesartan
Generic NameIrbesartan
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2012-10-23
Marketing CategoryANDA / ANDA
Application NumberANDA201531
Labeler NameLUPIN LIMITED
Substance NameIRBESARTAN
Active Ingredient Strength300 mg/1
Pharm ClassesAngiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 57297-412-09

90 TABLET in 1 BOTTLE (57297-412-09)
Marketing Start Date2012-10-23
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 57297-412-09 [57297041209]

Irbesartan TABLET
Marketing CategoryANDA
Application NumberANDA201531
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-10-23
Inactivation Date2020-01-31

NDC 57297-412-06 [57297041206]

Irbesartan TABLET
Marketing CategoryANDA
Application NumberANDA201531
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-10-23
Inactivation Date2020-01-31

NDC 57297-412-02 [57297041202]

Irbesartan TABLET
Marketing CategoryANDA
Application NumberANDA201531
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-10-23
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
IRBESARTAN300 mg/1

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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