NDC 13668-385

Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide 40/5/25 mg

Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide Tablet 40/5/25 Mg

Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide 40/5/25 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 ID: 13668-385_7b2f628e-b066-47f3-b5da-d6987ef76a29
• NDC: 13668-385
• Product Type: Human Prescription Drug
• Proprietary Name: Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide 40/5/25 mg
• Generic Name: Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide Tablet 40/5/25 Mg
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2016-10-26
• Marketing Category: ANDA / ANDA
• Application Number: ANDA203580
• Labeler Name: TORRENT PHARMACEUTICALS LIMITED
• Substance Name: OLMESARTAN MEDOXOMIL; AMLODIPINE; HYDROCHLOROTHIAZIDE
• Active Ingredient Strength: 40 mg/1; mg/1; mg/1
• Pharm Classes: 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]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 13668-385-05

500 TABLET in 1 BOTTLE (13668-385-05)

• Marketing Start Date: 2016-10-26
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 13668-385-74 [13668038574]

Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide 40/5/25 mg TABLET

• Marketing Category: ANDA
• Application Number: ANDA203580
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2016-10-26

NDC 13668-385-30 [13668038530]

Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide 40/5/25 mg TABLET

• Marketing Category: ANDA
• Application Number: ANDA203580
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-10-26

NDC 13668-385-90 [13668038590]

Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide 40/5/25 mg TABLET

• Marketing Category: ANDA
• Application Number: ANDA203580
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-10-26

NDC 13668-385-05 [13668038505]

Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide 40/5/25 mg TABLET

• Marketing Category: ANDA
• Application Number: ANDA203580
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2016-10-26

Drug Details

Active Ingredients

Ingredient	Strength
OLMESARTAN MEDOXOMIL	40 mg/1

OpenFDA Data

• SPL SET ID: 85b8f9c6-aa53-4aa1-85d6-19f823d0d252
• Manufacturer:
  • TORRENT PHARMACEUTICALS LIMITED
• UNII:
  • 6M97XTV3HD
  • 1J444QC288
  • 0J48LPH2TH
• 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]

Medicade Reported Pricing

13668038530 OLMSRTN-AMLDPN-HYDROCHLOROTHIAZIDE 40-5-25 MG

Pricing Unit: EA | Drug Type:

NDC Crossover Matching brand name "Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide 40/5/25 mg" or generic name "Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide Tablet 40/5/25 Mg"

NDC	Brand Name	Generic Name
13668-385	Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide 40/5/25 mg	Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablet 40/5/25 mg
70518-2647	Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide 40/5/25 mg	Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablet 40/5/25 mg