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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

  • ndc11
    0378820001
    100 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"
}

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