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United States · US · US:68391-604_379127e9-fb91-4556-9bc5-29f7ddc37577

Berkley and Jensen Ibuprofen

Orange BookUNIISPLATC G02CC01

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerBJWC
CountryUS (United States)
ATC codeG02CC01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6839160490
    500 TABLET, FILM COATED in 1 BOTTLE (68391-604-90)

Annotations

UNII (FDA Substance ID)
WK2XYI10QM
IBUPROFEN
RxCUI 5640
Orange Book
A072096
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "WK2XYI10QM",
    "rxcui": "5640",
    "inchikey": "HEFNNWSXXWATRW-UHFFFAOYSA-N",
    "display_name": "IBUPROFEN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "cda57e42-6106-46ee-82d1-479a692ee5bb": {
      "match": "brand_token",
      "title": "BERKLEY AND JENSEN IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [BJWC]",
      "spl_version": "9",
      "published_date": "2026-05-25"
    }
  },
  "productid": "68391-604_379127e9-fb91-4556-9bc5-29f7ddc37577",
  "productndc": "68391-604",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "072096",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "200MG",
        "product_no": "001",
        "approval_date": "Dec 8, 1987"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "IBUPROFEN",
  "proprietary_name": "Berkley and Jensen Ibuprofen",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA072096",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ibuprofen",
  "start_marketing_date": "20070620",
  "active_numerator_strength": "200"
}

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