felodipine

Generic: felodipine

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

Drug Facts

Product Profile

Brand Name felodipine
Generic Name felodipine
Labeler endo usa, inc.
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

felodipine 5 mg/1

Manufacturer
Endo USA, Inc.

Identifiers & Regulatory

Product NDC 0603-3582
Product ID 0603-3582_ca215c73-f6f1-492c-810c-876e46001086
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA200815
Listing Expiration 2026-12-31
Marketing Start 2011-12-15

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 06033582
Hyphenated Format 0603-3582

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 ANDA200815 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0603-3582-21)
  • 500 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0603-3582-28)
source: ndc

Packages (2)

0603-3582-21 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0603-3582-21) 0603-3582-28 500 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0603-3582-28)

Ingredients (1)

felodipine (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": "ca215c73-f6f1-492c-810c-876e46001086", "openfda": {"nui": ["N0000000069", "N0000175421", "M0006414"], "unii": ["OL961R6O2C"], "rxcui": ["402695", "402696", "402698"], "spl_set_id": ["55637724-8757-11de-8a39-0800200c9a66"], "pharm_class_cs": ["Dihydropyridines [CS]"], "pharm_class_epc": ["Dihydropyridine Calcium Channel Blocker [EPC]"], "pharm_class_moa": ["Calcium Channel Antagonists [MoA]"], "manufacturer_name": ["Endo USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0603-3582-21)", "package_ndc": "0603-3582-21", "marketing_start_date": "20111215"}, {"sample": false, "description": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0603-3582-28)", "package_ndc": "0603-3582-28", "marketing_start_date": "20111215"}], "brand_name": "Felodipine", "product_id": "0603-3582_ca215c73-f6f1-492c-810c-876e46001086", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Calcium Channel Antagonists [MoA]", "Dihydropyridine Calcium Channel Blocker [EPC]", "Dihydropyridines [CS]"], "product_ndc": "0603-3582", "generic_name": "Felodipine", "labeler_name": "Endo USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Felodipine", "active_ingredients": [{"name": "FELODIPINE", "strength": "5 mg/1"}], "application_number": "ANDA200815", "marketing_category": "ANDA", "marketing_start_date": "20111215", "listing_expiration_date": "20261231"}