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United States · US · US:63187-994_f65ac1f3-6065-44e4-ae2b-da5e52c81157

Diclofenac Sodium

Orange BookUNIISPLATC M01AB55

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

Identification

ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeM01AB55
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 5

  • ndc11
    6318799415
    15 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63187-994-15)
  • ndc11
    6318799420
    20 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63187-994-20)
  • ndc11
    6318799430
    30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63187-994-30)
  • ndc11
    6318799460
    60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63187-994-60)
  • ndc11
    6318799490
    90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63187-994-90)

Annotations

UNII (FDA Substance ID)
QTG126297Q
DICLOFENAC SODIUM
RxCUI 203214
Orange Book
A075492
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": "63187-994_f65ac1f3-6065-44e4-ae2b-da5e52c81157",
  "productndc": "63187-994",
  "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "075492",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "001",
        "approval_date": "Feb 11, 2000"
      }
    ],
    "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": "ANDA075492",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Diclofenac Sodium",
  "start_marketing_date": "20000228",
  "active_numerator_strength": "100"
}

Related drugs

Other records sharing ATC code M01AB55.

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