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United States · US · US:67296-1936_46e93923-334c-68db-e063-6394a90ad902

misoprostol

Orange BookUNIISPLATC G02AD06

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

Identification

ManufacturerRedpharm Drug
CountryUS (United States)
ATC codeG02AD06
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6729619361
    10 TABLET in 1 BOTTLE (67296-1936-1)

Annotations

UNII (FDA Substance ID)
0E43V0BB57
MISOPROSTOL
RxCUI 42331
Orange Book
N019268
ABAB
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": "67296-1936_46e93923-334c-68db-e063-6394a90ad902",
  "productndc": "67296-1936",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "019268",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "0.2MG",
        "product_no": "001",
        "approval_date": "Dec 27, 1988"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "0.1MG",
        "product_no": "003",
        "approval_date": "Sep 21, 1990"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MISOPROSTOL",
  "proprietary_name": "misoprostol",
  "active_ingred_unit": "ug/1",
  "application_number": "NDA019268",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "MISOPROSTOL",
  "start_marketing_date": "20091227",
  "active_numerator_strength": "200"
}

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