NDC 61919-516

OLMESARTAN MEDOXOMIL/HCTZ

Olmesartan Medoxomil/hctz

OLMESARTAN MEDOXOMIL/HCTZ is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Directrx. The primary component is Olmesartan Medoxomil; Hydrochlorothiazide.

• Product ID: 61919-516_86e20f02-2592-9a32-e053-2991aa0a3936
• NDC: 61919-516
• Product Type: Human Prescription Drug
• Proprietary Name: OLMESARTAN MEDOXOMIL/HCTZ
• Generic Name: Olmesartan Medoxomil/hctz
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2019-04-19
• Marketing Category: ANDA / ANDA
• Application Number: ANDA205391
• Labeler Name: DirectRX
• Substance Name: OLMESARTAN MEDOXOMIL; HYDROCHLOROTHIAZIDE
• Active Ingredient Strength: 20 mg/1; mg/1
• Pharm Classes: Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 61919-516-90

90 TABLET, FILM COATED in 1 BOTTLE (61919-516-90)

• Marketing Start Date: 2019-04-19
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 61919-516-90 [61919051690]

OLMESARTAN MEDOXOMIL/HCTZ TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA205391
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-04-19

Drug Details

Active Ingredients

Ingredient	Strength
OLMESARTAN MEDOXOMIL	20 mg/1

OpenFDA Data

• SPL SET ID: 86e20f02-2591-9a32-e053-2991aa0a3936
• Manufacturer:
  • DirectRX
• UNII:
  • 6M97XTV3HD
  • 0J48LPH2TH

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]