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United States · US · US:0259-5010_b0f65c2b-ee14-421f-9f24-178e108e38cf
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
- ndc11025950106060 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0259-5010-60)
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": "0259-5010_b0f65c2b-ee14-421f-9f24-178e108e38cf",
"productndc": "0259-5010",
"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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- 🇺🇸DalfampridineAccord Healthcare Inc.
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