Diclofenac Sodium

Orange BookUNIISPLATC M01AB55

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

Identification

ManufacturerProficient Rx LP

CountryUS (United States)

ATC codeM01AB55

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 8

ndc11
7120599100
100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (71205-991-00)
ndc11
7120599111
1000 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (71205-991-11)
ndc11
7120599130
30 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (71205-991-30)
ndc11
7120599155
500 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (71205-991-55)
ndc11
7120599160
60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (71205-991-60)
ndc11
7120599172
120 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (71205-991-72)
ndc11
7120599178
180 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (71205-991-78)
ndc11
7120599190
90 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (71205-991-90)

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": "71205-991_38aee69e-e66f-42b1-814a-551742b1a9cd",
  "productndc": "71205-991",
  "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": "75"
}

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