NDC 65862-629

Irbesartan and Hydrochlorothiazide

Irbesartan And Hydrochlorothiazide

Irbesartan and Hydrochlorothiazide is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Aurobindo Pharma Limited. The primary component is Irbesartan; Hydrochlorothiazide.

Product ID65862-629_6107622c-d425-41a3-b748-4e8e1914a205
NDC65862-629
Product TypeHuman Prescription Drug
Proprietary NameIrbesartan and Hydrochlorothiazide
Generic NameIrbesartan And Hydrochlorothiazide
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2013-02-22
Marketing CategoryANDA / DRUG FOR FURTHER PROCESSING
Application NumberANDA203630
Labeler NameAurobindo Pharma Limited
Substance NameIRBESARTAN; HYDROCHLOROTHIAZIDE
Active Ingredient Strength150 mg/1; mg/1
Pharm ClassesAngiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 65862-629-05

500 TABLET, FILM COATED in 1 BOTTLE (65862-629-05)
Marketing Start Date2013-02-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65862-629-90 [65862062990]

Irbesartan and Hydrochlorothiazide TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA203630
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-02-22

NDC 65862-629-30 [65862062930]

Irbesartan and Hydrochlorothiazide TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA203630
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-02-22

NDC 65862-629-99 [65862062999]

Irbesartan and Hydrochlorothiazide TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA203630
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-02-22

NDC 65862-629-05 [65862062905]

Irbesartan and Hydrochlorothiazide TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA203630
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-02-22

Drug Details

Active Ingredients

IngredientStrength
IRBESARTAN150 mg/1

NDC Crossover Matching brand name "Irbesartan and Hydrochlorothiazide" or generic name "Irbesartan And Hydrochlorothiazide"

NDCBrand NameGeneric Name
0054-0254Irbesartan and HydrochlorothiazideIrbesartan and Hydrochlorothiazide
0054-0255Irbesartan and HydrochlorothiazideIrbesartan and Hydrochlorothiazide
0093-8232Irbesartan and HydrochlorothiazideIrbesartan and Hydrochlorothiazide
0093-8238Irbesartan and HydrochlorothiazideIrbesartan and Hydrochlorothiazide
0955-1045Irbesartan and Hydrochlorothiazideirbesartan and hydrochlorothiazide
0955-1046Irbesartan and Hydrochlorothiazideirbesartan and hydrochlorothiazide
68071-2123Irbesartan and HydrochlorothiazideIrbesartan and Hydrochlorothiazide
68180-413Irbesartan and HydrochlorothiazideIrbesartan and Hydrochlorothiazide
68180-414Irbesartan and HydrochlorothiazideIrbesartan and Hydrochlorothiazide
68645-405Irbesartan and HydrochlorothiazideIrbesartan and Hydrochlorothiazide
70518-1386Irbesartan and HydrochlorothiazideIrbesartan and Hydrochlorothiazide
70518-1331Irbesartan and HydrochlorothiazideIrbesartan and Hydrochlorothiazide
70518-1330Irbesartan and HydrochlorothiazideIrbesartan and Hydrochlorothiazide
70518-1550Irbesartan and HydrochlorothiazideIrbesartan and Hydrochlorothiazide
70518-1780Irbesartan and HydrochlorothiazideIrbesartan and Hydrochlorothiazide
71205-063Irbesartan and HydrochlorothiazideIrbesartan and Hydrochlorothiazide
29300-215Irbesartan and HydrochlorothiazideIrbesartan and Hydrochlorothiazide
29300-216Irbesartan and HydrochlorothiazideIrbesartan and Hydrochlorothiazide
33342-058Irbesartan and HydrochlorothiazideIrbesartan and Hydrochlorothiazide
33342-057Irbesartan and HydrochlorothiazideIrbesartan and Hydrochlorothiazide
42291-342Irbesartan and HydrochlorothiazideIrbesartan and Hydrochlorothiazide
42291-343Irbesartan and HydrochlorothiazideIrbesartan and Hydrochlorothiazide
42658-141IRBESARTAN AND HYDROCHLOROTHIAZIDEIRBESARTAN AND HYDROCHLOROTHIAZIDE
42658-142IRBESARTAN AND HYDROCHLOROTHIAZIDEIRBESARTAN AND HYDROCHLOROTHIAZIDE
43547-331Irbesartan and HydrochlorothiazideIrbesartan and Hydrochlorothiazide
43547-330Irbesartan and HydrochlorothiazideIrbesartan and Hydrochlorothiazide
46708-442Irbesartan and HydrochlorothiazideIrbesartan and Hydrochlorothiazide
46708-444Irbesartan and HydrochlorothiazideIrbesartan and Hydrochlorothiazide
46708-443Irbesartan and HydrochlorothiazideIrbesartan and Hydrochlorothiazide
57297-414Irbesartan and HydrochlorothiazideIrbesartan and Hydrochlorothiazide
57297-413Irbesartan and HydrochlorothiazideIrbesartan and Hydrochlorothiazide
62332-053Irbesartan and HydrochlorothiazideIrbesartan and Hydrochlorothiazide
62332-051Irbesartan and HydrochlorothiazideIrbesartan and Hydrochlorothiazide
62332-052Irbesartan and HydrochlorothiazideIrbesartan and Hydrochlorothiazide
63187-981Irbesartan and HydrochlorothiazideIrbesartan and Hydrochlorothiazide
63187-653Irbesartan and HydrochlorothiazideIrbesartan and Hydrochlorothiazide
63629-7468Irbesartan and HydrochlorothiazideIrbesartan and Hydrochlorothiazide
64980-383Irbesartan and HydrochlorothiazideIrbesartan and Hydrochlorothiazide
64980-384Irbesartan and HydrochlorothiazideIrbesartan and Hydrochlorothiazide
64980-382Irbesartan and HydrochlorothiazideIrbesartan and Hydrochlorothiazide
65862-631Irbesartan and HydrochlorothiazideIrbesartan and Hydrochlorothiazide
65862-629Irbesartan and HydrochlorothiazideIrbesartan and Hydrochlorothiazide
65862-630Irbesartan and HydrochlorothiazideIrbesartan and Hydrochlorothiazide
70518-2013Irbesartan and HydrochlorothiazideIrbesartan and Hydrochlorothiazide
71335-1097Irbesartan and HydrochlorothiazideIrbesartan and Hydrochlorothiazide
70518-2247Irbesartan and HydrochlorothiazideIrbesartan and Hydrochlorothiazide
0024-5855Avalideirbesartan and hydrochlorothiazide
0024-5856Avalideirbesartan and hydrochlorothiazide

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