felodipine

Generic: felodipine

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name felodipine
Generic Name felodipine
Labeler aurobindo pharma limited
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

felodipine 2.5 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-673
Product ID 65862-673_a8579789-363a-44b3-be60-fe7bad9b16a9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203417
Listing Expiration 2026-12-31
Marketing Start 2013-01-17

Pharmacologic Class

Established (EPC)
dihydropyridine calcium channel blocker [epc]
Mechanism of Action
calcium channel antagonists [moa]
Chemical Structure
dihydropyridines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65862673
Hyphenated Format 65862-673

Supplemental Identifiers

RxCUI
402695 402696 402698
UNII
OL961R6O2C
NUI
N0000000069 N0000175421 M0006414

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 felodipine (source: ndc)
Generic Name felodipine (source: ndc)
Application Number ANDA203417 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-673-01)
  • 10 BLISTER PACK in 1 CARTON (65862-673-78) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (65862-673-10)
  • 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-673-90)
  • 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-673-99)
source: ndc

Packages (4)

65862-673-01 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-673-01) 65862-673-78 10 BLISTER PACK in 1 CARTON (65862-673-78) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (65862-673-10) 65862-673-90 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-673-90) 65862-673-99 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-673-99)

Ingredients (1)

felodipine (2.5 mg/1)

Linked Drug Pages (1)

Felodipine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "a8579789-363a-44b3-be60-fe7bad9b16a9", "openfda": {"nui": ["N0000000069", "N0000175421", "M0006414"], "unii": ["OL961R6O2C"], "rxcui": ["402695", "402696", "402698"], "spl_set_id": ["dd39c559-5c5d-4d3b-9228-c44085e1699f"], "pharm_class_cs": ["Dihydropyridines [CS]"], "pharm_class_epc": ["Dihydropyridine Calcium Channel Blocker [EPC]"], "pharm_class_moa": ["Calcium Channel Antagonists [MoA]"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-673-01)", "package_ndc": "65862-673-01", "marketing_start_date": "20130117"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (65862-673-78)  / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (65862-673-10)", "package_ndc": "65862-673-78", "marketing_start_date": "20130117"}, {"sample": false, "description": "90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-673-90)", "package_ndc": "65862-673-90", "marketing_start_date": "20130117"}, {"sample": false, "description": "1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-673-99)", "package_ndc": "65862-673-99", "marketing_start_date": "20130117"}], "brand_name": "Felodipine", "product_id": "65862-673_a8579789-363a-44b3-be60-fe7bad9b16a9", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Calcium Channel Antagonists [MoA]", "Dihydropyridine Calcium Channel Blocker [EPC]", "Dihydropyridines [CS]"], "product_ndc": "65862-673", "generic_name": "Felodipine", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Felodipine", "active_ingredients": [{"name": "FELODIPINE", "strength": "2.5 mg/1"}], "application_number": "ANDA203417", "marketing_category": "ANDA", "marketing_start_date": "20130117", "listing_expiration_date": "20261231"}