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United States · US · US:13913-008_73f6a60d-3089-4936-84df-8c28c49cb441

ZIPSOR

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 · 1

  • ndc11
    1391300812
    120 CAPSULE, LIQUID FILLED in 1 BOTTLE (13913-008-12)

Annotations

UNII (FDA Substance ID)
L4D5UA6CB4
DICLOFENAC POTASSIUM
RxCUI 81997
Orange Book
N022202
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": {
    "c982eca0-fc41-11e1-a9c8-0002a5d5c51b": {
      "match": "brand_token",
      "title": "ZIPSOR (DICLOFENAC POTASSIUM) CAPSULE, LIQUID FILLED [ASSERTIO THERAPEUTICS, INC.]",
      "spl_version": "15",
      "published_date": "2025-09-08"
    }
  },
  "productid": "13913-008_73f6a60d-3089-4936-84df-8c28c49cb441",
  "productndc": "13913-008",
  "dosage_form": "CAPSULE, LIQUID FILLED",
  "orange_book": {
    "appl_no": "022202",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "25MG",
        "product_no": "001",
        "approval_date": "Jun 16, 2009"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DICLOFENAC POTASSIUM",
  "proprietary_name": "ZIPSOR",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA022202",
  "marketing_category": "NDA",
  "nonproprietary_name": "diclofenac potassium",
  "start_marketing_date": "20090616",
  "active_numerator_strength": "25"
}

Related drugs

Other records sharing ATC code M01AB55.

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