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United States · US · US:43547-003_8a52d7dc-58d1-4dec-bfbd-5424ec30b984
FINGOLIMOD
Orange BookUNIISPLATC L04AE01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSolco Healthcare US, LLC
CountryUS (United States)
ATC codeL04AE01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11435470030330 CAPSULE in 1 BOTTLE (43547-003-03)
- ndc11435470030990 CAPSULE in 1 BOTTLE (43547-003-09)
Annotations
UNII (FDA Substance ID)
3QN8BYN5QF
FINGOLIMOD
RxCUI 1012892
Orange Book
A208003
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "3QN8BYN5QF",
"rxcui": "1012892",
"inchikey": "KKGQTZUTZRNORY-UHFFFAOYSA-N",
"display_name": "FINGOLIMOD",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"e1960f9b-f739-452c-b167-245551bf3690": {
"match": "brand_token",
"title": "FINGOLIMOD CAPSULE [CIVICASCRIPT LLC]",
"spl_version": "1",
"published_date": "2026-06-02"
}
},
"productid": "43547-003_8a52d7dc-58d1-4dec-bfbd-5424ec30b984",
"productndc": "43547-003",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "208003",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 0.5MG BASE",
"product_no": "001",
"approval_date": "Sep 7, 2022"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FINGOLIMOD",
"proprietary_name": "FINGOLIMOD",
"active_ingred_unit": "mg/1",
"application_number": "ANDA208003",
"marketing_category": "ANDA",
"nonproprietary_name": "fingolimod",
"start_marketing_date": "20200217",
"active_numerator_strength": ".5"
}Related drugs
Other records sharing ATC code L04AE01.
- CAACH-FINGOLIMODACCORD HEALTHCARE INC
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- FIAreleptanPharmaselect International Beteiligungs GmbH
- DKAreleptanPharmaselect International Beteiligungs GmbH
- CZARELEPTANPharmaselect International Beteiligungs GmbH, Vídeň
- CZARELEPTANPharmaselect International Beteiligungs GmbH, Vídeň
- CZARELEPTANPharmaselect International Beteiligungs GmbH, Vídeň
- CZARELEPTANPharmaselect International Beteiligungs GmbH, Vídeň
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