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United States · US · US:0378-8200_2dad8626-e0dd-46ad-9e75-069c6e82fc20
Ketoprofen
Orange BookUNIISPLATC M01AE53
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMylan Pharmaceuticals Inc.
CountryUS (United States)
ATC codeM01AE53
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc110378820001100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0378-8200-01)
Annotations
UNII (FDA Substance ID)
90Y4QC304K
KETOPROFEN
RxCUI 6142
Orange Book
A075679
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "90Y4QC304K",
"rxcui": "6142",
"inchikey": "DKYWVDODHFEZIM-UHFFFAOYSA-N",
"display_name": "KETOPROFEN",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"4e7bceb6-dcb5-c5e0-e063-6294a90a101e": {
"match": "brand_token",
"title": "KETOPROFEN CAPSULE [MARNEL PHARMACEUTICALS, INC.]",
"spl_version": "1",
"published_date": "2026-04-14"
}
},
"productid": "0378-8200_2dad8626-e0dd-46ad-9e75-069c6e82fc20",
"productndc": "0378-8200",
"dosage_form": "CAPSULE, EXTENDED RELEASE",
"orange_book": {
"appl_no": "075679",
"products": [
{
"rs": true,
"rld": false,
"te_code": null,
"strength": "200MG",
"product_no": "001",
"approval_date": "Feb 20, 2002"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "150MG",
"product_no": "002",
"approval_date": "Feb 20, 2002"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "100MG",
"product_no": "003",
"approval_date": "Feb 20, 2002"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "KETOPROFEN",
"proprietary_name": "Ketoprofen",
"active_ingred_unit": "mg/1",
"application_number": "ANDA075679",
"marketing_category": "ANDA",
"nonproprietary_name": "ketoprofen",
"start_marketing_date": "20030904",
"active_numerator_strength": "200"
}Related drugs
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