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United States · US · US:68071-4843_1ae170f1-2117-c3ed-e063-6294a90a6536

Misoprostol

Orange BookUNIISPLATC G02AD06

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

Identification

ManufacturerNuCare Pharmaceuticals,Inc.
CountryUS (United States)
ATC codeG02AD06
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6807148433
    3 TABLET in 1 BOTTLE (68071-4843-3)

Annotations

UNII (FDA Substance ID)
0E43V0BB57
MISOPROSTOL
RxCUI 42331
Orange Book
A091667
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "0E43V0BB57",
    "rxcui": "42331",
    "inchikey": "OJLOPKGSLYJEMD-URPKTTJQSA-N",
    "display_name": "MISOPROSTOL",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "c4fe14fb-0a43-4c31-9cd6-29eb0d156705": {
      "match": "brand_token",
      "title": "MISOPROSTOL TABLET [MYLAN PHARMACEUTICALS INC.]",
      "spl_version": "15",
      "published_date": "2026-05-25"
    }
  },
  "productid": "68071-4843_1ae170f1-2117-c3ed-e063-6294a90a6536",
  "productndc": "68071-4843",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "091667",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "0.1MG",
        "product_no": "001",
        "approval_date": "Jul 25, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "0.2MG",
        "product_no": "002",
        "approval_date": "Jul 25, 2012"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MISOPROSTOL",
  "proprietary_name": "Misoprostol",
  "active_ingred_unit": "ug/1",
  "application_number": "ANDA091667",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Misoprostol",
  "start_marketing_date": "20120725",
  "active_numerator_strength": "200"
}

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