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United States · US · US:68788-8193_403085a5-446c-4796-aaf1-64be07a98c9a

Diclofenac Sodium

Orange BookUNIISPLATC M01AB55

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

Identification

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

Packs · 5

  • ndc11
    6878881931
    100 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-8193-1)
  • ndc11
    6878881933
    30 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-8193-3)
  • ndc11
    6878881936
    60 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-8193-6)
  • ndc11
    6878881938
    120 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-8193-8)
  • ndc11
    6878881939
    90 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-8193-9)

Annotations

UNII (FDA Substance ID)
QTG126297Q
DICLOFENAC SODIUM
RxCUI 203214
Orange Book
A077863
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": "68788-8193_403085a5-446c-4796-aaf1-64be07a98c9a",
  "productndc": "68788-8193",
  "dosage_form": "TABLET, DELAYED RELEASE",
  "orange_book": {
    "appl_no": "077863",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "75MG",
        "product_no": "003",
        "approval_date": "Jun 8, 2007"
      }
    ],
    "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": "ANDA077863",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Diclofenac Sodium",
  "start_marketing_date": "20220516",
  "active_numerator_strength": "75"
}

Related drugs

Other records sharing ATC code M01AB55.

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