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United States · US · US:16571-202_504b1904-033c-4fd8-92c9-41e31154f808

Diclofenac Sodium

Orange BookUNIISPLATC M01AB55

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

Identification

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

Packs · 3

  • ndc11
    1657120206
    60 TABLET, DELAYED RELEASE in 1 BOTTLE (16571-202-06)
  • ndc11
    1657120210
    100 TABLET, DELAYED RELEASE in 1 BOTTLE (16571-202-10)
  • ndc11
    1657120211
    1000 TABLET, DELAYED RELEASE in 1 BOTTLE (16571-202-11)

Annotations

UNII (FDA Substance ID)
QTG126297Q
DICLOFENAC SODIUM
RxCUI 203214
Orange Book
A090066
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": "16571-202_504b1904-033c-4fd8-92c9-41e31154f808",
  "productndc": "16571-202",
  "dosage_form": "TABLET, DELAYED RELEASE",
  "orange_book": {
    "appl_no": "090066",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG",
        "product_no": "001",
        "approval_date": "Dec 1, 2010"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "002",
        "approval_date": "Dec 1, 2010"
      }
    ],
    "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": "ANDA090066",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Diclofenac Sodium",
  "start_marketing_date": "20101231",
  "active_numerator_strength": "50"
}

Related drugs

Other records sharing ATC code M01AB55.

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