dalfampridine

Generic: dalfampridine

Labeler: micro labs limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dalfampridine
Generic Name dalfampridine
Labeler micro labs limited
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

dalfampridine 10 mg/1

Manufacturer
Micro Labs Limited

Identifiers & Regulatory

Product NDC 42571-275
Product ID 42571-275_3afc3c42-1157-b612-e063-6294a90ac179
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210158
Listing Expiration 2026-12-31
Marketing Start 2019-03-21

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 42571275
Hyphenated Format 42571-275

Supplemental Identifiers

RxCUI
897021
UPC
0342571275600
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 ANDA210158 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (42571-275-05)
  • 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (42571-275-10)
  • 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (42571-275-60)
source: ndc

Packages (3)

42571-275-05 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (42571-275-05) 42571-275-10 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (42571-275-10) 42571-275-60 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (42571-275-60)

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": "3afc3c42-1157-b612-e063-6294a90ac179", "openfda": {"nui": ["N0000192795", "N0000175448"], "upc": ["0342571275600"], "unii": ["BH3B64OKL9"], "rxcui": ["897021"], "spl_set_id": ["302c8270-4711-4ca4-bee8-be0738fbe094"], "pharm_class_epc": ["Potassium Channel Blocker [EPC]"], "pharm_class_moa": ["Potassium Channel Antagonists [MoA]"], "manufacturer_name": ["Micro Labs Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (42571-275-05)", "package_ndc": "42571-275-05", "marketing_start_date": "20190321"}, {"sample": false, "description": "1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (42571-275-10)", "package_ndc": "42571-275-10", "marketing_start_date": "20190321"}, {"sample": false, "description": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (42571-275-60)", "package_ndc": "42571-275-60", "marketing_start_date": "20190321"}], "brand_name": "DALFAMPRIDINE", "product_id": "42571-275_3afc3c42-1157-b612-e063-6294a90ac179", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Potassium Channel Antagonists [MoA]", "Potassium Channel Blocker [EPC]"], "product_ndc": "42571-275", "generic_name": "DALFAMPRIDINE", "labeler_name": "Micro Labs Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DALFAMPRIDINE", "active_ingredients": [{"name": "DALFAMPRIDINE", "strength": "10 mg/1"}], "application_number": "ANDA210158", "marketing_category": "ANDA", "marketing_start_date": "20190321", "listing_expiration_date": "20261231"}