NDC 71335-1263

Irbesartan

Irbesartan

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

Product ID71335-1263_40f595be-32bd-4d03-9067-bf674511dd98
NDC71335-1263
Product TypeHuman Prescription Drug
Proprietary NameIrbesartan
Generic NameIrbesartan
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2012-09-27
Marketing CategoryANDA / ANDA
Application NumberANDA202254
Labeler NameBryant Ranch Prepack
Substance NameIRBESARTAN
Active Ingredient Strength150 mg/1
Pharm ClassesAngiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 71335-1263-1

30 TABLET in 1 BOTTLE (71335-1263-1)
Marketing Start Date2015-05-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71335-1263-2 [71335126302]

Irbesartan TABLET
Marketing CategoryANDA
Application NumberANDA202254
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-05-18

NDC 71335-1263-1 [71335126301]

Irbesartan TABLET
Marketing CategoryANDA
Application NumberANDA202254
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-05-18

NDC 71335-1263-3 [71335126303]

Irbesartan TABLET
Marketing CategoryANDA
Application NumberANDA202254
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-05-18

Drug Details

Active Ingredients

IngredientStrength
IRBESARTAN150 mg/1

OpenFDA Data

SPL SET ID:bc07bbf5-b1c6-4854-b6af-e06520c20728
Manufacturer
UNII

Pharmacological Class

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