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United States · US · US:85766-032_4a2b79c2-3d4a-4fe7-e063-6394a90a3acb

Diclofenac sodium

Orange BookUNIISPLATC M01AB55

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

Identification

ManufacturerSportpharm LLC
CountryUS (United States)
ATC codeM01AB55
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 7

  • ndc11
    8576603201
    100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (85766-032-01)
  • ndc11
    8576603207
    7 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (85766-032-07)
  • ndc11
    8576603214
    14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (85766-032-14)
  • ndc11
    8576603220
    20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (85766-032-20)
  • ndc11
    8576603230
    30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (85766-032-30)
  • ndc11
    8576603260
    60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (85766-032-60)
  • ndc11
    8576603290
    90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (85766-032-90)

Annotations

UNII (FDA Substance ID)
QTG126297Q
DICLOFENAC SODIUM
RxCUI 203214
Orange Book
A216275
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "QTG126297Q",
    "rxcui": "203214",
    "inchikey": "KPHWPUGNDIVLNH-UHFFFAOYSA-M",
    "display_name": "DICLOFENAC SODIUM",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "86461915-9bc1-43d4-8d92-6eef3e56bd90": {
      "match": "brand_token",
      "title": "DICLOFENAC POTASSIUM TABLET, COATED [BRYANT RANCH PREPACK]",
      "spl_version": "104",
      "published_date": "2026-06-01"
    }
  },
  "productid": "85766-032_4a2b79c2-3d4a-4fe7-e063-6394a90a3acb",
  "productndc": "85766-032",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "216275",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "001",
        "approval_date": "Sep 23, 2022"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DICLOFENAC SODIUM",
  "proprietary_name": "Diclofenac sodium",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA216275",
  "marketing_category": "ANDA",
  "nonproprietary_name": "diclofenac sodium",
  "start_marketing_date": "20220926",
  "active_numerator_strength": "100"
}

Related drugs

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