dalfampridine

Generic: dalfampridine

Labeler: ascend laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dalfampridine
Generic Name dalfampridine
Labeler ascend laboratories, llc
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

dalfampridine 10 mg/1

Manufacturer
Ascend Laboratories, LLC

Identifiers & Regulatory

Product NDC 67877-444
Product ID 67877-444_4dbba67c-d169-4c7d-a152-b0e603a4b72b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206765
Listing Expiration 2026-12-31
Marketing Start 2018-07-31

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 67877444
Hyphenated Format 67877-444

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 ANDA206765 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (67877-444-05)
  • 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (67877-444-60)
  • 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (67877-444-90)
source: ndc

Packages (3)

67877-444-05 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (67877-444-05) 67877-444-60 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (67877-444-60) 67877-444-90 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (67877-444-90)

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": "4dbba67c-d169-4c7d-a152-b0e603a4b72b", "openfda": {"nui": ["N0000192795", "N0000175448"], "unii": ["BH3B64OKL9"], "rxcui": ["897021"], "spl_set_id": ["e10b2d92-2824-4395-8883-6fd52c784aa4"], "pharm_class_epc": ["Potassium Channel Blocker [EPC]"], "pharm_class_moa": ["Potassium Channel Antagonists [MoA]"], "manufacturer_name": ["Ascend Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (67877-444-05)", "package_ndc": "67877-444-05", "marketing_start_date": "20180731"}, {"sample": false, "description": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (67877-444-60)", "package_ndc": "67877-444-60", "marketing_start_date": "20180731"}, {"sample": false, "description": "90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (67877-444-90)", "package_ndc": "67877-444-90", "marketing_start_date": "20180731"}], "brand_name": "Dalfampridine", "product_id": "67877-444_4dbba67c-d169-4c7d-a152-b0e603a4b72b", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Potassium Channel Antagonists [MoA]", "Potassium Channel Blocker [EPC]"], "product_ndc": "67877-444", "generic_name": "Dalfampridine", "labeler_name": "Ascend Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dalfampridine", "active_ingredients": [{"name": "DALFAMPRIDINE", "strength": "10 mg/1"}], "application_number": "ANDA206765", "marketing_category": "ANDA", "marketing_start_date": "20180731", "listing_expiration_date": "20261231"}