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United States · US · US:42571-275_3afc3c42-1157-b612-e063-6294a90ac179

DALFAMPRIDINE

Orange BookUNIISPLATC N07XX07

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

Identification

ManufacturerMicro Labs Limited
CountryUS (United States)
ATC codeN07XX07
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    4257127505
    500 TABLET, EXTENDED RELEASE in 1 BOTTLE (42571-275-05)
  • ndc11
    4257127510
    1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (42571-275-10)
  • ndc11
    4257127560
    60 TABLET, EXTENDED RELEASE in 1 BOTTLE (42571-275-60)

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": "42571-275_3afc3c42-1157-b612-e063-6294a90ac179",
  "productndc": "42571-275",
  "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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