🇺🇸
United States · US · US:42571-275_3afc3c42-1157-b612-e063-6294a90ac179
DALFAMPRIDINE
Orange BookUNIISPLATC N07XX07
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMicro Labs Limited
CountryUS (United States)
ATC codeN07XX07
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc114257127505500 TABLET, EXTENDED RELEASE in 1 BOTTLE (42571-275-05)
- ndc1142571275101000 TABLET, EXTENDED RELEASE in 1 BOTTLE (42571-275-10)
- ndc11425712756060 TABLET, EXTENDED RELEASE in 1 BOTTLE (42571-275-60)
Annotations
UNII (FDA Substance ID)
BH3B64OKL9
DALFAMPRIDINE
RxCUI 897018
Orange Book
A210158
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": "42571-275_3afc3c42-1157-b612-e063-6294a90ac179",
"productndc": "42571-275",
"dosage_form": "TABLET, EXTENDED RELEASE",
"orange_book": {
"appl_no": "210158",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "001",
"approval_date": "Mar 11, 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": "ANDA210158",
"marketing_category": "ANDA",
"nonproprietary_name": "DALFAMPRIDINE",
"start_marketing_date": "20190321",
"active_numerator_strength": "10"
}Related drugs
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