olmesartan medoxomil

Generic: olmesartan medoxomil

Labeler: glenmark pharmaceuticals inc., usa
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name olmesartan medoxomil
Generic Name olmesartan medoxomil
Labeler glenmark pharmaceuticals inc., usa
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

olmesartan medoxomil 40 mg/1

Manufacturer
Glenmark Pharmaceuticals Inc., USA

Identifiers & Regulatory

Product NDC 68462-438
Product ID 68462-438_3d590efe-ccb3-4ca3-b49e-9547dd674eae
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203281
Listing Expiration 2027-12-31
Marketing Start 2017-05-25

Pharmacologic Class

Classes
angiotensin 2 receptor antagonists [moa] angiotensin 2 receptor blocker [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68462438
Hyphenated Format 68462-438

Supplemental Identifiers

RxCUI
349373 349401 349405
UPC
0368462438305 0368462437308 0368462436301
UNII
6M97XTV3HD

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name olmesartan medoxomil (source: ndc)
Generic Name olmesartan medoxomil (source: ndc)
Application Number ANDA203281 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 1000 TABLET, FILM COATED in 1 BOTTLE (68462-438-10)
  • 10 BLISTER PACK in 1 CARTON (68462-438-11) / 10 TABLET, FILM COATED in 1 BLISTER PACK
  • 30 TABLET, FILM COATED in 1 BOTTLE (68462-438-30)
  • 90 TABLET, FILM COATED in 1 BOTTLE (68462-438-90)
source: ndc

Packages (4)

68462-438-10 1000 TABLET, FILM COATED in 1 BOTTLE (68462-438-10) 68462-438-11 10 BLISTER PACK in 1 CARTON (68462-438-11) / 10 TABLET, FILM COATED in 1 BLISTER PACK 68462-438-30 30 TABLET, FILM COATED in 1 BOTTLE (68462-438-30) 68462-438-90 90 TABLET, FILM COATED in 1 BOTTLE (68462-438-90)

Ingredients (1)

olmesartan medoxomil (40 mg/1)

Linked Drug Pages (1)

Olmesartan Medoxomil ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3d590efe-ccb3-4ca3-b49e-9547dd674eae", "openfda": {"upc": ["0368462438305", "0368462437308", "0368462436301"], "unii": ["6M97XTV3HD"], "rxcui": ["349373", "349401", "349405"], "spl_set_id": ["8e0adf3d-7569-4909-bab1-5fed9578ad77"], "manufacturer_name": ["Glenmark Pharmaceuticals Inc., USA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (68462-438-10)", "package_ndc": "68462-438-10", "marketing_start_date": "20170525"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (68462-438-11)  / 10 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "68462-438-11", "marketing_start_date": "20170525"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (68462-438-30)", "package_ndc": "68462-438-30", "marketing_start_date": "20170525"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (68462-438-90)", "package_ndc": "68462-438-90", "marketing_start_date": "20170525"}], "brand_name": "Olmesartan Medoxomil", "product_id": "68462-438_3d590efe-ccb3-4ca3-b49e-9547dd674eae", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Angiotensin 2 Receptor Antagonists [MoA]", "Angiotensin 2 Receptor Blocker [EPC]"], "product_ndc": "68462-438", "generic_name": "Olmesartan Medoxomil", "labeler_name": "Glenmark Pharmaceuticals Inc., USA", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Olmesartan Medoxomil", "active_ingredients": [{"name": "OLMESARTAN MEDOXOMIL", "strength": "40 mg/1"}], "application_number": "ANDA203281", "marketing_category": "ANDA", "marketing_start_date": "20170525", "listing_expiration_date": "20271231"}