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United States · US · US:62756-538_9f3fe78f-5fa7-48ab-90cc-5c0ba82c1fb2
Riluzole
In shortageOrange BookUNIISPLATC N07XX02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSun Pharmaceutical Industries, Inc.
CountryUS (United States)
ATC codeN07XX02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc1162756538181000 TABLET, FILM COATED in 1 BOTTLE (62756-538-18)
- ndc11627565388330 TABLET, FILM COATED in 1 BOTTLE (62756-538-83)
- ndc11627565388660 TABLET, FILM COATED in 1 BOTTLE (62756-538-86)
- ndc116275653888100 TABLET, FILM COATED in 1 BOTTLE (62756-538-88)
Annotations
UNII (FDA Substance ID)
7LJ087RS6F
RILUZOLE
RxCUI 35623
Orange Book
A091417
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Riluzole Oral Suspension
Raw payload (JSON)
{
"unii": {
"unii": "7LJ087RS6F",
"rxcui": "35623",
"inchikey": "FTALBRSUTCGOEG-UHFFFAOYSA-N",
"display_name": "RILUZOLE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"ccead445-970c-46a1-9532-2848cc2aa3b6": {
"match": "brand_token",
"title": "RILUZOLE TABLET, FILM COATED [FLORIDA PHARMACEUTICAL PRODUCTS, LLC]",
"spl_version": "8",
"published_date": "2026-04-27"
}
},
"productid": "62756-538_9f3fe78f-5fa7-48ab-90cc-5c0ba82c1fb2",
"productndc": "62756-538",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "091417",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "50MG",
"product_no": "001",
"approval_date": "Jun 18, 2013"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "RILUZOLE",
"shortage_reason": "Riluzole Oral Suspension",
"shortage_status": "current",
"proprietary_name": "Riluzole",
"active_ingred_unit": "mg/1",
"application_number": "ANDA091417",
"marketing_category": "ANDA",
"nonproprietary_name": "Riluzole",
"start_marketing_date": "20130618",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code N07XX02.
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