dalfampridine

Generic: dalfampridine

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dalfampridine
Generic Name dalfampridine
Labeler aurobindo pharma limited
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

dalfampridine 10 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-863
Product ID 65862-863_8a071f78-8849-495d-ad29-832d5f250a19
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206811
Listing Expiration 2026-12-31
Marketing Start 2018-06-25

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 65862863
Hyphenated Format 65862-863

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 ANDA206811 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-863-01)
  • 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-863-05)
  • 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-863-60)
source: ndc

Packages (3)

65862-863-01 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-863-01) 65862-863-05 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-863-05) 65862-863-60 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-863-60)

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": "8a071f78-8849-495d-ad29-832d5f250a19", "openfda": {"nui": ["N0000192795", "N0000175448"], "unii": ["BH3B64OKL9"], "rxcui": ["897021"], "spl_set_id": ["43996322-7d83-4420-9e61-4ed37f710fee"], "pharm_class_epc": ["Potassium Channel Blocker [EPC]"], "pharm_class_moa": ["Potassium Channel Antagonists [MoA]"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-863-01)", "package_ndc": "65862-863-01", "marketing_start_date": "20180625"}, {"sample": false, "description": "500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-863-05)", "package_ndc": "65862-863-05", "marketing_start_date": "20180625"}, {"sample": false, "description": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-863-60)", "package_ndc": "65862-863-60", "marketing_start_date": "20180625"}], "brand_name": "DALFAMPRIDINE", "product_id": "65862-863_8a071f78-8849-495d-ad29-832d5f250a19", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Potassium Channel Antagonists [MoA]", "Potassium Channel Blocker [EPC]"], "product_ndc": "65862-863", "generic_name": "DALFAMPRIDINE", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DALFAMPRIDINE", "active_ingredients": [{"name": "DALFAMPRIDINE", "strength": "10 mg/1"}], "application_number": "ANDA206811", "marketing_category": "ANDA", "marketing_start_date": "20180625", "listing_expiration_date": "20261231"}