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United States · US · US:69616-211_4f94edd2-b6a8-264d-e063-6294a90a89df
Firdapse
Orange BookUNIISPLATC N07XX05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCatalyst Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeN07XX05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc116961621103240 TABLET in 1 BOTTLE, PLASTIC (69616-211-03)
- ndc11696162110612 BLISTER PACK in 1 CARTON (69616-211-06) / 10 TABLET in 1 BLISTER PACK (69616-211-04)
- ndc11696162110860 TABLET in 1 BOTTLE, PLASTIC (69616-211-08)
Annotations
UNII (FDA Substance ID)
8HF8FIN815
AMIFAMPRIDINE PHOSPHATE
RxCUI 2106337
Orange Book
N208078
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "8HF8FIN815",
"rxcui": "2106337",
"inchikey": "KAICRBBQCRKMPO-UHFFFAOYSA-N",
"display_name": "AMIFAMPRIDINE PHOSPHATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"f015fe60-3128-4a43-8c31-19fc6b5def3f": {
"match": "brand_token",
"title": "FIRDAPSE (AMIFAMPRIDINE PHOSPHATE) TABLET [CATALYST PHARMACEUTICALS, INC.]",
"spl_version": "15",
"published_date": "2026-04-17"
}
},
"productid": "69616-211_4f94edd2-b6a8-264d-e063-6294a90a89df",
"productndc": "69616-211",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "208078",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 10MG BASE",
"product_no": "001",
"approval_date": "Nov 28, 2018"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "AMIFAMPRIDINE PHOSPHATE",
"proprietary_name": "Firdapse",
"active_ingred_unit": "mg/1",
"application_number": "NDA208078",
"marketing_category": "NDA",
"nonproprietary_name": "amifampridine phosphate",
"start_marketing_date": "20190107",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code N07XX05.
- GB3,4-Diaminopyridine 10mg tabletsSpecial Order
- GB3,4-Diaminopyridine 20mg tabletsSpecial Order
- GBAmifampridine 10mg tabletsLupin Healthcare (UK) Ltd
- GBAmifampridine 10mg tabletsSpecial Order
- GBAmifampridine 20mg tabletsSpecial Order
- NOAmifampridine AccordAccord Healthcare B.V.
- NLAmifampridine Accord 10 mg tablettenAccord Healthcare B.V.
- NLAmifampridine Amarox 10 mg tablettenAmarox Pharma B.V.
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