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United States · US · US:63629-9450_54a7930d-8690-451e-b3f6-3f27e11ad03e
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
- ndc11636299450160 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-9450-1)
Annotations
UNII (FDA Substance ID)
BH3B64OKL9
DALFAMPRIDINE
RxCUI 897018
Orange Book
A206765
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": "63629-9450_54a7930d-8690-451e-b3f6-3f27e11ad03e",
"productndc": "63629-9450",
"dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
"orange_book": {
"appl_no": "206765",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "001",
"approval_date": "Jul 30, 2018"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DALFAMPRIDINE",
"proprietary_name": "Dalfampridine",
"active_ingred_unit": "mg/1",
"application_number": "ANDA206765",
"marketing_category": "ANDA",
"nonproprietary_name": "Dalfampridine",
"start_marketing_date": "20180731",
"active_numerator_strength": "10"
}Related drugs
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