NDC 70518-2013

Irbesartan and Hydrochlorothiazide

Irbesartan And Hydrochlorothiazide

Irbesartan and Hydrochlorothiazide is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Remedyrepack Inc.. The primary component is Irbesartan; Hydrochlorothiazide.

Product ID70518-2013_865b49cd-1cf9-8176-e053-2a91aa0a5275
NDC70518-2013
Product TypeHuman Prescription Drug
Proprietary NameIrbesartan and Hydrochlorothiazide
Generic NameIrbesartan And Hydrochlorothiazide
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2019-04-12
Marketing CategoryANDA / ANDA
Application NumberANDA090351
Labeler NameREMEDYREPACK INC.
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 Through2020-12-31

Packaging

NDC 70518-2013-0

90 TABLET in 1 BOTTLE, PLASTIC (70518-2013-0)
Marketing Start Date2019-04-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70518-2013-0 [70518201300]

Irbesartan and Hydrochlorothiazide TABLET
Marketing CategoryANDA
Application NumberANDA090351
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-04-12

Drug Details

Active Ingredients

IngredientStrength
IRBESARTAN150 mg/1

OpenFDA Data

SPL SET ID:3233569a-23c6-469e-8d13-5af9ca38e310
Manufacturer
UNII

Pharmacological Class

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

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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