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United States · US · US:68391-205_f8497dc3-9d28-4ad9-8770-eb36ed0563cb

berkley and jensen arthritis pain

Orange BookSPL

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

Identification

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

Packs · 1

  • ndc11
    6839120500
    1 KIT in 1 PACKAGE (68391-205-00) * 1 TUBE in 1 CARTON (68391-871-02) / 50 g in 1 TUBE * 2 TUBE in 1 CARTON (68391-871-00) / 150 g in 1 TUBE (68391-871-03)

Annotations

Orange Book
A211253
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "route": null,
  "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": "68391-205_f8497dc3-9d28-4ad9-8770-eb36ed0563cb",
  "productndc": "68391-205",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "211253",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "1%",
        "product_no": "001",
        "approval_date": "May 16, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": null,
  "proprietary_name": "berkley and jensen arthritis pain",
  "active_ingred_unit": null,
  "application_number": "ANDA211253",
  "marketing_category": "ANDA",
  "nonproprietary_name": "diclofenac sodium",
  "start_marketing_date": "20211110",
  "active_numerator_strength": null
}

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