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United States · US · US:13913-012_b9a3d927-3dc3-4860-ac3b-3dd20df47dd6

Cambia

Orange BookUNIISPLATC M01AB55

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

Identification

ManufacturerAssertio Therapeutics, Inc.
CountryUS (United States)
ATC codeM01AB55
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    1391301202
    9 PACKET in 1 CARTON (13913-012-02) / 1 POWDER, FOR SOLUTION in 1 PACKET
  • ndc11
    1391301203
    9 PACKET in 1 CARTON (13913-012-03) / 1 POWDER, FOR SOLUTION in 1 PACKET (13913-012-01)

Annotations

UNII (FDA Substance ID)
L4D5UA6CB4
DICLOFENAC POTASSIUM
RxCUI 81997
Orange Book
N022165
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "L4D5UA6CB4",
    "rxcui": "81997",
    "inchikey": "KXZOIWWTXOCYKR-UHFFFAOYSA-M",
    "display_name": "DICLOFENAC POTASSIUM",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "d249ced1-4ca0-4f57-adcb-23440f58f659": {
      "match": "brand_token",
      "title": "CAMBIA (DICLOFENAC POTASSIUM) POWDER, FOR SOLUTION [ASSERTIO THERAPEUTICS, INC.]",
      "spl_version": "9",
      "published_date": "2024-12-16"
    }
  },
  "productid": "13913-012_b9a3d927-3dc3-4860-ac3b-3dd20df47dd6",
  "productndc": "13913-012",
  "dosage_form": "POWDER, FOR SOLUTION",
  "orange_book": {
    "appl_no": "022165",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "001",
        "approval_date": "Jun 17, 2009"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DICLOFENAC POTASSIUM",
  "proprietary_name": "Cambia",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA022165",
  "marketing_category": "NDA",
  "nonproprietary_name": "diclofenac potassium",
  "start_marketing_date": "20160310",
  "active_numerator_strength": "50"
}

Related drugs

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