NDC 71205-452

Irbesartan

Irbesartan

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

Product ID71205-452_208cd661-160f-46e4-b9d1-6eaf7bd39ba0
NDC71205-452
Product TypeHuman Prescription Drug
Proprietary NameIrbesartan
Generic NameIrbesartan
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2012-09-27
Marketing CategoryANDA / ANDA
Application NumberANDA202910
Labeler NameProficient Rx LP
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 71205-452-30

30 TABLET in 1 BOTTLE (71205-452-30)
Marketing Start Date2020-04-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71205-452-60 [71205045260]

Irbesartan TABLET
Marketing CategoryANDA
Application NumberANDA202910
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-04-01

NDC 71205-452-30 [71205045230]

Irbesartan TABLET
Marketing CategoryANDA
Application NumberANDA202910
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-04-01

NDC 71205-452-90 [71205045290]

Irbesartan TABLET
Marketing CategoryANDA
Application NumberANDA202910
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-04-01

Drug Details

Active Ingredients

IngredientStrength
IRBESARTAN150 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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.