amlodipine and olmesartan medoxomil

Generic: amlodipine and olmesartan medoxomil

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

Drug Facts

Product Profile

Brand Name amlodipine and olmesartan medoxomil
Generic Name amlodipine and olmesartan medoxomil
Labeler camber pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

amlodipine besylate 5 mg/1, olmesartan medoxomil 20 mg/1

Manufacturer
Camber Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 31722-445
Product ID 31722-445_313d90a7-6e92-d956-e063-6394a90a3d6e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209591
Listing Expiration 2026-12-31
Marketing Start 2025-02-14

Pharmacologic Class

Classes
angiotensin 2 receptor antagonists [moa] angiotensin 2 receptor blocker [epc] calcium channel antagonists [moa] calcium channel blocker [epc] cytochrome p450 3a inhibitors [moa] dihydropyridine calcium channel blocker [epc] dihydropyridines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 31722445
Hyphenated Format 31722-445

Supplemental Identifiers

RxCUI
730861 730866 730869 730872
UPC
0331722448307 0331722447300 0331722445306 0331722446303
UNII
864V2Q084H 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 amlodipine and olmesartan medoxomil (source: ndc)
Generic Name amlodipine and olmesartan medoxomil (source: ndc)
Application Number ANDA209591 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
  • 20 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (31722-445-30)
  • 90 TABLET, FILM COATED in 1 BOTTLE (31722-445-90)
source: ndc

Packages (2)

Ingredients (2)

amlodipine besylate (5 mg/1) olmesartan medoxomil (20 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "313d90a7-6e92-d956-e063-6394a90a3d6e", "openfda": {"upc": ["0331722448307", "0331722447300", "0331722445306", "0331722446303"], "unii": ["864V2Q084H", "6M97XTV3HD"], "rxcui": ["730861", "730866", "730869", "730872"], "spl_set_id": ["99865c67-5475-4e60-98d5-a8fa850fe9ba"], "manufacturer_name": ["Camber Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (31722-445-30)", "package_ndc": "31722-445-30", "marketing_start_date": "20250214"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (31722-445-90)", "package_ndc": "31722-445-90", "marketing_start_date": "20250214"}], "brand_name": "Amlodipine and Olmesartan Medoxomil", "product_id": "31722-445_313d90a7-6e92-d956-e063-6394a90a3d6e", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Angiotensin 2 Receptor Antagonists [MoA]", "Angiotensin 2 Receptor Blocker [EPC]", "Calcium Channel Antagonists [MoA]", "Calcium Channel Blocker [EPC]", "Cytochrome P450 3A Inhibitors [MoA]", "Dihydropyridine Calcium Channel Blocker [EPC]", "Dihydropyridines [CS]"], "product_ndc": "31722-445", "generic_name": "Amlodipine and Olmesartan Medoxomil", "labeler_name": "Camber Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amlodipine and Olmesartan Medoxomil", "active_ingredients": [{"name": "AMLODIPINE BESYLATE", "strength": "5 mg/1"}, {"name": "OLMESARTAN MEDOXOMIL", "strength": "20 mg/1"}], "application_number": "ANDA209591", "marketing_category": "ANDA", "marketing_start_date": "20250214", "listing_expiration_date": "20261231"}