Diclofenac Sodium

Orange BookUNIISPLATC M01AB55

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerBryant Ranch Prepack

CountryUS (United States)

ATC codeM01AB55

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 10

ndc11
7133526840
40 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2684-0)
ndc11
7133526841
28 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2684-1)
ndc11
7133526842
60 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2684-2)
ndc11
7133526843
20 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2684-3)
ndc11
7133526844
30 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2684-4)
ndc11
7133526845
120 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2684-5)
ndc11
7133526846
90 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2684-6)
ndc11
7133526847
100 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2684-7)
ndc11
7133526848
15 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2684-8)
ndc11
7133526849
14 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2684-9)

Annotations

UNII (FDA Substance ID)

QTG126297Q

DICLOFENAC SODIUM

RxCUI 203214

Orange Book

A216548

ABABAB

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": "71335-2684_a18f3fb9-d435-4b8f-9081-22d615fe35eb",
  "productndc": "71335-2684",
  "dosage_form": "TABLET, DELAYED RELEASE",
  "orange_book": {
    "appl_no": "216548",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG",
        "product_no": "001",
        "approval_date": "May 11, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "002",
        "approval_date": "May 11, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "75MG",
        "product_no": "003",
        "approval_date": "May 11, 2023"
      }
    ],
    "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": "ANDA216548",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Diclofenac Sodium",
  "start_marketing_date": "20230511",
  "active_numerator_strength": "75"
}

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