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United States · US · US:76420-598_045ce619-2c60-e219-e063-6294a90a8cd5

Diclofenac sodium

Orange BookUNIISPLATC M01AB55

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

Identification

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

Packs · 7

  • ndc11
    7642059807
    7 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76420-598-07)
  • ndc11
    7642059810
    100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76420-598-10)
  • ndc11
    7642059814
    14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76420-598-14)
  • ndc11
    7642059820
    20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76420-598-20)
  • ndc11
    7642059830
    30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76420-598-30)
  • ndc11
    7642059860
    60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76420-598-60)
  • ndc11
    7642059890
    90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76420-598-90)

Annotations

UNII (FDA Substance ID)
QTG126297Q
DICLOFENAC SODIUM
RxCUI 203214
Orange Book
A216275
AB
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": "76420-598_045ce619-2c60-e219-e063-6294a90a8cd5",
  "productndc": "76420-598",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "216275",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "001",
        "approval_date": "Sep 23, 2022"
      }
    ],
    "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": "ANDA216275",
  "marketing_category": "ANDA",
  "nonproprietary_name": "diclofenac sodium",
  "start_marketing_date": "20220926",
  "active_numerator_strength": "100"
}

Related drugs

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