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United States · US · US:59762-0029_540456cf-d8d4-4c2f-883d-933c5d0b862b

Diclofenac sodium and Misoprostol

Orange BookUNIISPLATC D11AX

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

Identification

ManufacturerMylan Pharmaceuticals Inc.
CountryUS (United States)
ATC codeD11AX
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5976200291
    60 TABLET, FILM COATED in 1 BOTTLE (59762-0029-1)

Annotations

UNII (FDA Substance ID)
QTG126297Q
DICLOFENAC SODIUM
RxCUI 203214
Orange Book
N020607
ABAB
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": "59762-0029_540456cf-d8d4-4c2f-883d-933c5d0b862b",
  "productndc": "59762-0029",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "020607",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "50MG;0.2MG",
        "product_no": "001",
        "approval_date": "Dec 24, 1997"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "75MG;0.2MG",
        "product_no": "002",
        "approval_date": "Dec 24, 1997"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DICLOFENAC SODIUM; MISOPROSTOL",
  "proprietary_name": "Diclofenac sodium and Misoprostol",
  "active_ingred_unit": "mg/1; ug/1",
  "application_number": "NDA020607",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "Diclofenac sodium and Misoprostol",
  "start_marketing_date": "20121101",
  "active_numerator_strength": "75; 200"
}

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