NDC 55289-443

Benicar HCT

Olmesartan Medoxomil-hydrochlorothiazide

Benicar HCT is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Pd-rx Pharmaceuticals, Inc.. The primary component is Olmesartan Medoxomil; Hydrochlorothiazide.

• Product ID: 55289-443_7c4889dd-2a20-f1ec-e053-2991aa0a0e0c
• NDC: 55289-443
• Product Type: Human Prescription Drug
• Proprietary Name: Benicar HCT
• Generic Name: Olmesartan Medoxomil-hydrochlorothiazide
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2003-06-05
• Marketing Category: NDA / NDA
• Application Number: NDA021532
• Labeler Name: PD-Rx Pharmaceuticals, Inc.
• Substance Name: OLMESARTAN MEDOXOMIL; HYDROCHLOROTHIAZIDE
• Active Ingredient Strength: 40 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: 2019-12-31

Packaging

NDC 55289-443-30

30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-443-30)

• Marketing Start Date: 2012-05-04
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 55289-443-30 [55289044330]

Benicar HCT TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA021532
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2012-05-04
• Marketing End Date: 2019-09-12

Drug Details

Active Ingredients

Ingredient	Strength
OLMESARTAN MEDOXOMIL	40 mg/1

OpenFDA Data

• SPL SET ID: 91d45442-4232-4111-9dd8-0d787085af6d
• Manufacturer:
  • PD-Rx Pharmaceuticals, Inc.
• UNII:
  • 6M97XTV3HD
  • 0J48LPH2TH
• RxNorm Concept Unique ID - RxCUI:
  • 847042
  • 403855
• UPC Code:
  • 0355289443308

Pharmacological Class

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

NDC Crossover Matching brand name "Benicar HCT" or generic name "Olmesartan Medoxomil-hydrochlorothiazide"

NDC	Brand Name	Generic Name
0713-0863	Benicar HCT	olmesartan medoxomil-hydrochlorothiazide
0713-0864	Benicar HCT	olmesartan medoxomil-hydrochlorothiazide
0713-0865	Benicar HCT	olmesartan medoxomil-hydrochlorothiazide
50090-1083	Benicar HCT	olmesartan medoxomil-hydrochlorothiazide
55289-443	Benicar HCT	olmesartan medoxomil-hydrochlorothiazide
65597-105	Benicar HCT	olmesartan medoxomil-hydrochlorothiazide
65597-106	Benicar HCT	olmesartan medoxomil-hydrochlorothiazide
65597-107	Benicar HCT	olmesartan medoxomil-hydrochlorothiazide
50090-4329	Olmesartan Medoxomil and Hydrochlorothiazide	olmesartan medoxomil-hydrochlorothiazide
57664-758	Olmesartan Medoxomil and Hydrochlorothiazide	olmesartan medoxomil-hydrochlorothiazide
57664-759	Olmesartan Medoxomil and Hydrochlorothiazide	olmesartan medoxomil-hydrochlorothiazide
57664-760	Olmesartan Medoxomil and Hydrochlorothiazide	olmesartan medoxomil-hydrochlorothiazide
71335-0203	Olmesartan Medoxomil and Hydrochlorothiazide	olmesartan medoxomil-hydrochlorothiazide