NDC 57297-414

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 Lupin Limited. The primary component is Hydrochlorothiazide; Irbesartan.

Product ID57297-414_ac69bbca-81f4-4896-bb7e-df0a4428fe42
NDC57297-414
Product TypeHuman Prescription Drug
Proprietary NameIrbesartan and Hydrochlorothiazide
Generic NameIrbesartan And Hydrochlorothiazide
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2013-04-04
Marketing CategoryANDA / ANDA
Application NumberANDA201524
Labeler NameLUPIN LIMITED
Substance NameHYDROCHLOROTHIAZIDE; IRBESARTAN
Active Ingredient Strength13 mg/1; mg/1
Pharm ClassesIncreased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 57297-414-09

90 TABLET, FILM COATED in 1 BOTTLE (57297-414-09)
Marketing Start Date2013-04-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 57297-414-09 [57297041409]

Irbesartan and Hydrochlorothiazide TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA201524
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-04-04
Inactivation Date2020-01-31

NDC 57297-414-06 [57297041406]

Irbesartan and Hydrochlorothiazide TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA201524
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-04-04
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
HYDROCHLOROTHIAZIDE12.5 mg/1

Pharmacological Class

  • Increased Diuresis [PE]
  • Thiazide Diuretic [EPC]
  • Thiazides [CS]
  • Angiotensin 2 Receptor Antagonists [MoA]
  • Angiotensin 2 Receptor Blocker [EPC]

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
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