NDC 0093-5004

Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide

Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide

Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Teva Pharmaceuticals Usa, Inc.. The primary component is Olmesartan Medoxomil; Amlodipine Besylate; Hydrochlorothiazide.

• Product ID: 0093-5004_020adeeb-c840-4eab-91ab-781fa292fb0f
• NDC: 0093-5004
• Product Type: Human Prescription Drug
• Proprietary Name: Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide
• Generic Name: Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2016-11-14
• Marketing Category: ANDA / ANDA
• Application Number: ANDA202491
• Labeler Name: Teva Pharmaceuticals USA, Inc.
• Substance Name: OLMESARTAN MEDOXOMIL; AMLODIPINE BESYLATE; 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: 2020-12-31

Packaging

NDC 0093-5004-56

30 TABLET, FILM COATED in 1 BOTTLE (0093-5004-56)

• Marketing Start Date: 2016-11-14
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0093-5004-98 [00093500498]

Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA202491
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-11-14
• Marketing End Date: 2018-09-30

NDC 0093-5004-56 [00093500456]

Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA202491
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-11-14

Drug Details

Active Ingredients

Ingredient	Strength
OLMESARTAN MEDOXOMIL	40 mg/1

OpenFDA Data

• SPL SET ID: 5c128ef2-60a6-40f3-b37f-ee139fe27987
• Manufacturer:
  • Teva Pharmaceuticals USA, Inc.
• UNII:
  • 6M97XTV3HD
  • 864V2Q084H
  • 0J48LPH2TH
• RxNorm Concept Unique ID - RxCUI:
  • 999991
  • 999996
  • 999986
  • 1000001
  • 999967
• UPC Code:
  • 0300935006987
  • 0300935004983

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]

NDC Crossover Matching brand name "Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide" or generic name "Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide"

NDC	Brand Name	Generic Name
0093-5002	Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide	Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide
0093-5003	Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide	Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide
0093-5004	Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide	Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide
0093-5005	Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide	Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide
0093-5006	Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide	Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide
53808-1120	Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide	olmesartan medoxomil, amlodipine besylate and hydrochlorothiazide
57664-796	Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide	olmesartan medoxomil, amlodipine besylate and hydrochlorothiazide
57664-797	Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide	olmesartan medoxomil, amlodipine besylate and hydrochlorothiazide
70518-1648	Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide	Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide
57664-800	Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide	Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide
57664-798	Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide	Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide
57664-799	Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide	Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide