dalfampridine

Generic: dalfampridine

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dalfampridine
Generic Name dalfampridine
Labeler sun pharmaceutical industries, inc.
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

dalfampridine 10 mg/1

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 62756-429
Product ID 62756-429_c3c3b8ae-9dac-40fc-8569-b26d6befbf01
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208292
Listing Expiration 2026-12-31
Marketing Start 2019-05-22

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 62756429
Hyphenated Format 62756-429

Supplemental Identifiers

RxCUI
897021
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 dalfampridine (source: ndc)
Generic Name dalfampridine (source: ndc)
Application Number ANDA208292 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (62756-429-86)
source: ndc

Packages (1)

62756-429-86 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (62756-429-86)

Ingredients (1)

dalfampridine (10 mg/1)

Linked Drug Pages (1)

Dalfampridine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "c3c3b8ae-9dac-40fc-8569-b26d6befbf01", "openfda": {"nui": ["N0000192795", "N0000175448"], "unii": ["BH3B64OKL9"], "rxcui": ["897021"], "spl_set_id": ["d61e15fa-0334-49a0-ab41-c9a36b726b57"], "pharm_class_epc": ["Potassium Channel Blocker [EPC]"], "pharm_class_moa": ["Potassium Channel Antagonists [MoA]"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (62756-429-86)", "package_ndc": "62756-429-86", "marketing_start_date": "20190522"}], "brand_name": "Dalfampridine", "product_id": "62756-429_c3c3b8ae-9dac-40fc-8569-b26d6befbf01", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Potassium Channel Antagonists [MoA]", "Potassium Channel Blocker [EPC]"], "product_ndc": "62756-429", "generic_name": "Dalfampridine", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dalfampridine", "active_ingredients": [{"name": "DALFAMPRIDINE", "strength": "10 mg/1"}], "application_number": "ANDA208292", "marketing_category": "ANDA", "marketing_start_date": "20190522", "listing_expiration_date": "20261231"}