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United States · US · US:0591-0397_9d8d5f09-7764-4e55-87c6-d2fead0e6e97

Diclofenac Sodium and Misoprostol

Orange BookUNIISPLATC D11AX

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

Identification

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

Packs · 2

  • ndc11
    0591039719
    90 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (0591-0397-19)
  • ndc11
    0591039760
    60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (0591-0397-60)

Annotations

UNII (FDA Substance ID)
QTG126297Q
DICLOFENAC SODIUM
RxCUI 203214
Orange Book
A201089
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": "0591-0397_9d8d5f09-7764-4e55-87c6-d2fead0e6e97",
  "productndc": "0591-0397",
  "dosage_form": "TABLET, DELAYED RELEASE",
  "orange_book": {
    "appl_no": "201089",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG;0.2MG",
        "product_no": "001",
        "approval_date": "Jul 9, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "75MG;0.2MG",
        "product_no": "002",
        "approval_date": "Jul 9, 2012"
      }
    ],
    "appl_type": "A"
  },
  "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": "ANDA201089",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Diclofenac Sodium and Misoprostol",
  "start_marketing_date": "20121101",
  "active_numerator_strength": "50; 200"
}

Related drugs

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