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United States · US · US:64950-218_d3fa269f-43c4-4862-b4d2-ec5b04d050c8
Flurbiprofen
Orange BookUNIISPLATC M02AA19
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGenus Lifesciences
CountryUS (United States)
ATC codeM02AA19
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc116495021810100 TABLET in 1 BOTTLE (64950-218-10)
Annotations
UNII (FDA Substance ID)
5GRO578KLP
FLURBIPROFEN
RxCUI 4502
Orange Book
A074431
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "5GRO578KLP",
"rxcui": "4502",
"inchikey": "SYTBZMRGLBWNTM-UHFFFAOYSA-N",
"display_name": "FLURBIPROFEN",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"c27f2d57-4b9d-4b78-8d85-3bac84f733b1": {
"match": "brand_token",
"title": "FLURBIPROFEN SODIUM SOLUTION/ DROPS [AMICI PHARMA, INC.]",
"spl_version": "6",
"published_date": "2026-05-07"
}
},
"productid": "64950-218_d3fa269f-43c4-4862-b4d2-ec5b04d050c8",
"productndc": "64950-218",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "074431",
"products": [
{
"rs": true,
"rld": false,
"te_code": null,
"strength": "100MG",
"product_no": "001",
"approval_date": "May 31, 1995"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FLURBIPROFEN",
"proprietary_name": "Flurbiprofen",
"active_ingred_unit": "mg/1",
"application_number": "ANDA074431",
"marketing_category": "ANDA",
"nonproprietary_name": "Flurbiprofen",
"start_marketing_date": "20241101",
"active_numerator_strength": "100"
}Related drugs
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