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United States · US · US:72162-2459_fd48fc9a-fe75-4178-806c-ea935728cc7f

DALFAMPRIDINE

Orange BookUNIISPLATC N07XX07

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

Identification

ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeN07XX07
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7216224596
    60 TABLET, EXTENDED RELEASE in 1 BOTTLE (72162-2459-6)

Annotations

UNII (FDA Substance ID)
BH3B64OKL9
DALFAMPRIDINE
RxCUI 897018
Orange Book
A210158
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": "72162-2459_fd48fc9a-fe75-4178-806c-ea935728cc7f",
  "productndc": "72162-2459",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "210158",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Mar 11, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DALFAMPRIDINE",
  "proprietary_name": "DALFAMPRIDINE",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA210158",
  "marketing_category": "ANDA",
  "nonproprietary_name": "DALFAMPRIDINE",
  "start_marketing_date": "20190321",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code N07XX07.

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