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United States · US · US:82249-702_c40dcc84-b839-44aa-94f2-886fb1c3d75c

Dalfampridine

Orange BookUNIISPLATC N07XX07

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerCivicaScript LLC
CountryUS (United States)
ATC codeN07XX07
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    8224970260
    60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (82249-702-60)

Annotations

UNII (FDA Substance ID)
BH3B64OKL9
DALFAMPRIDINE
RxCUI 897018
Orange Book
A206765
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "BH3B64OKL9",
    "rxcui": "897018",
    "inchikey": "NUKYPUAOHBNCPY-UHFFFAOYSA-N",
    "display_name": "DALFAMPRIDINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "354a97e8-35c8-418b-91b2-9e8e066cec65": {
      "match": "brand_token",
      "title": "DALFAMPRIDINE TABLET, FILM COATED, EXTENDED RELEASE [ACCORD HEALTHCARE INC.]",
      "spl_version": "8",
      "published_date": "2025-11-17"
    }
  },
  "productid": "82249-702_c40dcc84-b839-44aa-94f2-886fb1c3d75c",
  "productndc": "82249-702",
  "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "206765",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Jul 30, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DALFAMPRIDINE",
  "proprietary_name": "Dalfampridine",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA206765",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Dalfampridine",
  "start_marketing_date": "20250721",
  "active_numerator_strength": "10"
}

Related drugs

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