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United States · US · US:10144-427_dda9045d-2f23-412c-9543-74832f421739

AMPYRA

Orange BookUNIISPLATC N07XX07

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

Identification

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

Packs · 1

  • ndc11
    1014442760
    60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (10144-427-60)

Annotations

UNII (FDA Substance ID)
BH3B64OKL9
DALFAMPRIDINE
RxCUI 897018
Orange Book
N022250
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": {
    "550eb76a-e4a6-4fa1-ad65-c0fd8b0ce783": {
      "match": "brand_token",
      "title": "AMPYRA (DALFAMPRIDINE) TABLET, FILM COATED, EXTENDED RELEASE [MERZ PHARMACEUTICALS, LLC]",
      "spl_version": "22",
      "published_date": "2026-01-23"
    }
  },
  "productid": "10144-427_dda9045d-2f23-412c-9543-74832f421739",
  "productndc": "10144-427",
  "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "022250",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Jan 22, 2010"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DALFAMPRIDINE",
  "proprietary_name": "AMPYRA",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA022250",
  "marketing_category": "NDA",
  "nonproprietary_name": "Dalfampridine",
  "start_marketing_date": "20100301",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code N07XX07.

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