🇺🇸
United States · US · US:65862-863_8a071f78-8849-495d-ad29-832d5f250a19
DALFAMPRIDINE
Orange BookUNIISPLATC N07XX07
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAurobindo Pharma Limited
CountryUS (United States)
ATC codeN07XX07
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc116586286301100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-863-01)
- ndc116586286305500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-863-05)
- ndc11658628636060 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-863-60)
Annotations
UNII (FDA Substance ID)
BH3B64OKL9
DALFAMPRIDINE
RxCUI 897018
Orange Book
A206811
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": "65862-863_8a071f78-8849-495d-ad29-832d5f250a19",
"productndc": "65862-863",
"dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
"orange_book": {
"appl_no": "206811",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "001",
"approval_date": "Jan 23, 2017"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DALFAMPRIDINE",
"proprietary_name": "DALFAMPRIDINE",
"active_ingred_unit": "mg/1",
"application_number": "ANDA206811",
"marketing_category": "ANDA",
"nonproprietary_name": "DALFAMPRIDINE",
"start_marketing_date": "20180625",
"active_numerator_strength": "10"
}Related drugs
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