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United States · US · US:62756-429_c3c3b8ae-9dac-40fc-8569-b26d6befbf01
Dalfampridine
Orange BookUNIISPLATC N07XX07
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSun Pharmaceutical Industries, Inc.
CountryUS (United States)
ATC codeN07XX07
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11627564298660 TABLET, EXTENDED RELEASE in 1 BOTTLE (62756-429-86)
Annotations
UNII (FDA Substance ID)
BH3B64OKL9
DALFAMPRIDINE
RxCUI 897018
Orange Book
A208292
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": "62756-429_c3c3b8ae-9dac-40fc-8569-b26d6befbf01",
"productndc": "62756-429",
"dosage_form": "TABLET, EXTENDED RELEASE",
"orange_book": {
"appl_no": "208292",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "10MG",
"product_no": "001",
"approval_date": "May 21, 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": "ANDA208292",
"marketing_category": "ANDA",
"nonproprietary_name": "Dalfampridine",
"start_marketing_date": "20190522",
"active_numerator_strength": "10"
}Related drugs
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