NDC 13668-383

Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide 40/10/12.5 mg

Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide Tablet 40/10/12.5 Mg

Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide 40/10/12.5 mg is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Torrent Pharmaceuticals Limited. The primary component is Olmesartan Medoxomil; Amlodipine; Hydrochlorothiazide.

Product ID13668-383_7b2f628e-b066-47f3-b5da-d6987ef76a29
NDC13668-383
Product TypeHuman Prescription Drug
Proprietary NameOlmesartan Medoxomil, Amlodipine and Hydrochlorothiazide 40/10/12.5 mg
Generic NameOlmesartan Medoxomil, Amlodipine And Hydrochlorothiazide Tablet 40/10/12.5 Mg
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2016-10-26
Marketing CategoryANDA / ANDA
Application NumberANDA203580
Labeler NameTORRENT PHARMACEUTICALS LIMITED
Substance NameOLMESARTAN MEDOXOMIL; AMLODIPINE; HYDROCHLOROTHIAZIDE
Active Ingredient Strength40 mg/1; mg/1; mg/1
Pharm ClassesAngiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 13668-383-05

500 TABLET in 1 BOTTLE (13668-383-05)
Marketing Start Date2016-10-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 13668-383-74 [13668038374]

Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide 40/10/12.5 mg TABLET
Marketing CategoryANDA
Application NumberANDA203580
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-10-26

NDC 13668-383-05 [13668038305]

Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide 40/10/12.5 mg TABLET
Marketing CategoryANDA
Application NumberANDA203580
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-10-26

NDC 13668-383-30 [13668038330]

Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide 40/10/12.5 mg TABLET
Marketing CategoryANDA
Application NumberANDA203580
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-10-26

NDC 13668-383-90 [13668038390]

Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide 40/10/12.5 mg TABLET
Marketing CategoryANDA
Application NumberANDA203580
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-10-26

Drug Details

Active Ingredients

IngredientStrength
OLMESARTAN MEDOXOMIL40 mg/1

OpenFDA Data

SPL SET ID:85b8f9c6-aa53-4aa1-85d6-19f823d0d252
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 999991
  • 999996
  • 999986
  • 1000001
  • 999967
    • UPC Code
  • 0313668382051
  • 0313668397055
  • 0313668386059
  • 0313668385052

    • Pharmacological Class

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