🇺🇸
United States · US · US:63629-8808_a91f60d1-facf-428e-8c1a-d57008beada4
Flurbiprofen
Orange BookUNIISPLATC M02AA19
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeM02AA19
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc116362988081100 TABLET, FILM COATED in 1 BOTTLE (63629-8808-1)
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": "63629-8808_a91f60d1-facf-428e-8c1a-d57008beada4",
"productndc": "63629-8808",
"dosage_form": "TABLET, FILM COATED",
"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": "19950602",
"active_numerator_strength": "100"
}Related drugs
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