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United States · US · US:42291-233_4dc7edc1-b426-ac49-e063-6294a90af71b

Diclofenac Sodium and Misoprostol

Orange BookUNIISPLATC D11AX

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

Identification

ManufacturerAvKARE
CountryUS (United States)
ATC codeD11AX
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    4229123360
    60 TABLET, DELAYED RELEASE in 1 BOTTLE (42291-233-60)

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": "42291-233_4dc7edc1-b426-ac49-e063-6294a90af71b",
  "productndc": "42291-233",
  "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": "20121214",
  "active_numerator_strength": "75; 200"
}

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