felodipine

Generic: felodipine

Labeler: carlsbad technology, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name felodipine
Generic Name felodipine
Labeler carlsbad technology, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

felodipine 10 mg/1

Manufacturer
Carlsbad Technology, Inc.

Identifiers & Regulatory

Product NDC 61442-433
Product ID 61442-433_2e6e562c-bff2-1d2f-e063-6394a90a5001
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204800
Listing Expiration 2026-12-31
Marketing Start 2020-10-12

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 61442433
Hyphenated Format 61442-433

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 ANDA204800 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (61442-433-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (61442-433-05)
source: ndc

Packages (2)

61442-433-01 100 TABLET, FILM COATED in 1 BOTTLE (61442-433-01) 61442-433-05 500 TABLET, FILM COATED in 1 BOTTLE (61442-433-05)

Ingredients (1)

felodipine (10 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": "2e6e562c-bff2-1d2f-e063-6394a90a5001", "openfda": {"nui": ["N0000000069", "N0000175421", "M0006414"], "unii": ["OL961R6O2C"], "rxcui": ["402695", "402696", "402698"], "spl_set_id": ["7bd4fa00-f0d8-4aea-9c24-a799b05e60e1"], "pharm_class_cs": ["Dihydropyridines [CS]"], "pharm_class_epc": ["Dihydropyridine Calcium Channel Blocker [EPC]"], "pharm_class_moa": ["Calcium Channel Antagonists [MoA]"], "manufacturer_name": ["Carlsbad Technology, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (61442-433-01)", "package_ndc": "61442-433-01", "marketing_start_date": "20201012"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (61442-433-05)", "package_ndc": "61442-433-05", "marketing_start_date": "20201012"}], "brand_name": "Felodipine", "product_id": "61442-433_2e6e562c-bff2-1d2f-e063-6394a90a5001", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Calcium Channel Antagonists [MoA]", "Dihydropyridine Calcium Channel Blocker [EPC]", "Dihydropyridines [CS]"], "product_ndc": "61442-433", "generic_name": "Felodipine", "labeler_name": "Carlsbad Technology, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Felodipine", "active_ingredients": [{"name": "FELODIPINE", "strength": "10 mg/1"}], "application_number": "ANDA204800", "marketing_category": "ANDA", "marketing_start_date": "20201012", "listing_expiration_date": "20261231"}