firdapse

Generic: amifampridine phosphate

Labeler: catalyst pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name firdapse
Generic Name amifampridine phosphate
Labeler catalyst pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

amifampridine phosphate 10 mg/1

Manufacturer
Catalyst Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 69616-211
Product ID 69616-211_55bc5d79-864c-4a58-a75c-a2ea62b0bf58
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA208078
Listing Expiration 2026-12-31
Marketing Start 2019-01-07

Pharmacologic Class

Classes
potassium channel antagonists [moa] potassium channel blocker [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69616211
Hyphenated Format 69616-211

Supplemental Identifiers

RxCUI
2106343 2107518
UNII
8HF8FIN815

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 firdapse (source: ndc)
Generic Name amifampridine phosphate (source: ndc)
Application Number NDA208078 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 240 TABLET in 1 BOTTLE, PLASTIC (69616-211-03)
  • 12 BLISTER PACK in 1 CARTON (69616-211-06) / 10 TABLET in 1 BLISTER PACK (69616-211-04)
  • 60 TABLET in 1 BOTTLE, PLASTIC (69616-211-08)
source: ndc

Packages (3)

69616-211-03 240 TABLET in 1 BOTTLE, PLASTIC (69616-211-03) 69616-211-06 12 BLISTER PACK in 1 CARTON (69616-211-06) / 10 TABLET in 1 BLISTER PACK (69616-211-04) 69616-211-08 60 TABLET in 1 BOTTLE, PLASTIC (69616-211-08)

Ingredients (1)

amifampridine phosphate (10 mg/1)

Linked Drug Pages (1)

Firdapse ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "55bc5d79-864c-4a58-a75c-a2ea62b0bf58", "openfda": {"unii": ["8HF8FIN815"], "rxcui": ["2106343", "2107518"], "spl_set_id": ["f015fe60-3128-4a43-8c31-19fc6b5def3f"], "manufacturer_name": ["Catalyst Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "240 TABLET in 1 BOTTLE, PLASTIC (69616-211-03)", "package_ndc": "69616-211-03", "marketing_start_date": "20190107"}, {"sample": false, "description": "12 BLISTER PACK in 1 CARTON (69616-211-06)  / 10 TABLET in 1 BLISTER PACK (69616-211-04)", "package_ndc": "69616-211-06", "marketing_start_date": "20190107"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE, PLASTIC (69616-211-08)", "package_ndc": "69616-211-08", "marketing_start_date": "20190107"}], "brand_name": "Firdapse", "product_id": "69616-211_55bc5d79-864c-4a58-a75c-a2ea62b0bf58", "dosage_form": "TABLET", "pharm_class": ["Potassium Channel Antagonists [MoA]", "Potassium Channel Blocker [EPC]"], "product_ndc": "69616-211", "generic_name": "amifampridine phosphate", "labeler_name": "Catalyst Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Firdapse", "active_ingredients": [{"name": "AMIFAMPRIDINE PHOSPHATE", "strength": "10 mg/1"}], "application_number": "NDA208078", "marketing_category": "NDA", "marketing_start_date": "20190107", "listing_expiration_date": "20261231"}