Back to search
🇺🇸

United States · US · US:0025-1461_882c6a95-ced5-4c8a-a72f-8ca5ed499a6d

Cytotec

Orange BookUNIISPLATC G02AD06

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

Identification

ManufacturerPfizer Laboratories Div Pfizer Inc
CountryUS (United States)
ATC codeG02AD06
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 0

No packs registered.

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": {
    "4ab12da7-5731-4e06-bf1c-bc3f2e711f12": {
      "match": "brand_token",
      "title": "CYTOTEC (MISOPROSTOL) TABLET [PFIZER LABORATORIES DIV PFIZER INC]",
      "spl_version": "21",
      "published_date": "2026-05-28"
    }
  },
  "productid": "0025-1461_882c6a95-ced5-4c8a-a72f-8ca5ed499a6d",
  "productndc": "0025-1461",
  "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": "Cytotec",
  "active_ingred_unit": "ug/1",
  "application_number": "NDA019268",
  "marketing_category": "NDA",
  "nonproprietary_name": "misoprostol",
  "start_marketing_date": "19861227",
  "active_numerator_strength": "200"
}

Related drugs

Other records sharing ATC code G02AD06.

Access this data programmatically

Query Cytotec and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.