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United States · US · US:85509-1103_43923c68-87ab-1ab7-e063-6394a90adf7a

Diclofenac Sodium

Orange BookUNIISPLATC M01AB55

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

Identification

ManufacturerPHOENIX RX LLC
CountryUS (United States)
ATC codeM01AB55
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    8550911033
    30 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (85509-1103-3)
  • ndc11
    8550911036
    60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (85509-1103-6)
  • ndc11
    8550911039
    90 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (85509-1103-9)

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": "85509-1103_43923c68-87ab-1ab7-e063-6394a90adf7a",
  "productndc": "85509-1103",
  "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"
}

Related drugs

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