ampyra

Generic: dalfampridine

Labeler: merz pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name ampyra
Generic Name dalfampridine
Labeler merz pharmaceuticals, llc
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

dalfampridine 10 mg/1

Manufacturer
Merz Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 0259-5010
Product ID 0259-5010_b0f65c2b-ee14-421f-9f24-178e108e38cf
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022250
Listing Expiration 2026-12-31
Marketing Start 2010-03-01

Pharmacologic Class

Established (EPC)
potassium channel blocker [epc]
Mechanism of Action
potassium channel antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 02595010
Hyphenated Format 0259-5010

Supplemental Identifiers

RxCUI
897021 897025
UNII
BH3B64OKL9
NUI
N0000192795 N0000175448

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 ampyra (source: ndc)
Generic Name dalfampridine (source: ndc)
Application Number NDA022250 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0259-5010-60)
source: ndc

Packages (1)

0259-5010-60 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0259-5010-60)

Ingredients (1)

dalfampridine (10 mg/1)

Linked Drug Pages (1)

AMPYRA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "b0f65c2b-ee14-421f-9f24-178e108e38cf", "openfda": {"nui": ["N0000192795", "N0000175448"], "unii": ["BH3B64OKL9"], "rxcui": ["897021", "897025"], "spl_set_id": ["974fb2af-7012-4989-b330-e44a31c9c3e5"], "pharm_class_epc": ["Potassium Channel Blocker [EPC]"], "pharm_class_moa": ["Potassium Channel Antagonists [MoA]"], "manufacturer_name": ["Merz Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0259-5010-60)", "package_ndc": "0259-5010-60", "marketing_start_date": "20100301"}], "brand_name": "AMPYRA", "product_id": "0259-5010_b0f65c2b-ee14-421f-9f24-178e108e38cf", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Potassium Channel Antagonists [MoA]", "Potassium Channel Blocker [EPC]"], "product_ndc": "0259-5010", "generic_name": "Dalfampridine", "labeler_name": "Merz Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "AMPYRA", "active_ingredients": [{"name": "DALFAMPRIDINE", "strength": "10 mg/1"}], "application_number": "NDA022250", "marketing_category": "NDA", "marketing_start_date": "20100301", "listing_expiration_date": "20261231"}