Diclofenac Sodium

Orange BookUNIISPLATC M01AB55

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

Identification

ManufacturerNuCare Pharmaceuticals,Inc.

CountryUS (United States)

ATC codeM01AB55

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 5

ndc11
6807142311
21 TABLET, DELAYED RELEASE in 1 BOTTLE (68071-4231-1)
ndc11
6807142313
30 TABLET, DELAYED RELEASE in 1 BOTTLE (68071-4231-3)
ndc11
6807142315
45 TABLET, DELAYED RELEASE in 1 BOTTLE (68071-4231-5)
ndc11
6807142316
60 TABLET, DELAYED RELEASE in 1 BOTTLE (68071-4231-6)
ndc11
6807142319
90 TABLET, DELAYED RELEASE in 1 BOTTLE (68071-4231-9)

Annotations

UNII (FDA Substance ID)

QTG126297Q

DICLOFENAC SODIUM

RxCUI 203214

Orange Book

A075185

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": "68071-4231_1a3c5c49-b374-1318-e063-6394a90a47b6",
  "productndc": "68071-4231",
  "dosage_form": "TABLET, DELAYED RELEASE",
  "orange_book": {
    "appl_no": "075185",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "75MG",
        "product_no": "001",
        "approval_date": "Nov 13, 1998"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG",
        "product_no": "002",
        "approval_date": "Nov 13, 1998"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "003",
        "approval_date": "Nov 13, 1998"
      }
    ],
    "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": "ANDA075185",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Diclofenac Sodium",
  "start_marketing_date": "19981113",
  "active_numerator_strength": "50"
}

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