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United States · US · US:0228-2550_138c73c2-488a-440d-9a47-7a2a56920f2b

Diclofenac Sodium

Orange BookUNIISPLATC M01AB55

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

Identification

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

Packs · 3

  • ndc11
    0228255006
    60 TABLET, DELAYED RELEASE in 1 BOTTLE (0228-2550-06)
  • ndc11
    0228255011
    100 TABLET, DELAYED RELEASE in 1 BOTTLE (0228-2550-11)
  • ndc11
    0228255096
    1000 TABLET, DELAYED RELEASE in 1 BOTTLE (0228-2550-96)

Annotations

UNII (FDA Substance ID)
QTG126297Q
DICLOFENAC SODIUM
RxCUI 203214
Orange Book
A074514
ABAB
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": "0228-2550_138c73c2-488a-440d-9a47-7a2a56920f2b",
  "productndc": "0228-2550",
  "dosage_form": "TABLET, DELAYED RELEASE",
  "orange_book": {
    "appl_no": "074514",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "001",
        "approval_date": "Mar 26, 1996"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "75MG",
        "product_no": "002",
        "approval_date": "Mar 26, 1996"
      }
    ],
    "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": "ANDA074514",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Diclofenac Sodium",
  "start_marketing_date": "19960326",
  "active_numerator_strength": "50"
}

Related drugs

Other records sharing ATC code M01AB55.

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