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United States · US · US:81665-202_4cded8b1-0f1c-219d-e063-6294a90a64e2

CARBOPROST TROMETHAMINE

Orange BookUNIISPLATC G02AD

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

Identification

ManufacturerOmnivium Pharmaceuticals LLC
CountryUS (United States)
ATC codeG02AD
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    8166520201
    1 mL in 1 AMPULE (81665-202-01)
  • ndc11
    8166520210
    10 AMPULE in 1 CARTON (81665-202-10) / 1 mL in 1 AMPULE (81665-202-01)

Annotations

UNII (FDA Substance ID)
U4526F86FJ
CARBOPROST TROMETHAMINE
RxCUI 20259
Orange Book
A213118
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "U4526F86FJ",
    "rxcui": "20259",
    "inchikey": "UMMADZJLZAPZAW-XOWPVRJPSA-N",
    "display_name": "CARBOPROST TROMETHAMINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAMUSCULAR",
  "spl_meta": {
    "aa42587d-7213-4a46-9050-9bbfbb081de5": {
      "match": "brand_token",
      "title": "CARBOPROST TROMETHAMINE SOLUTION [HIKMA PHARMACEUTICALS USA INC.]",
      "spl_version": "2",
      "published_date": "2026-03-05"
    }
  },
  "productid": "81665-202_4cded8b1-0f1c-219d-e063-6294a90a64e2",
  "productndc": "81665-202",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "213118",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 0.25MG BASE/ML",
        "product_no": "001",
        "approval_date": "Mar 25, 2021"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CARBOPROST TROMETHAMINE",
  "proprietary_name": "CARBOPROST TROMETHAMINE",
  "active_ingred_unit": "ug/mL",
  "application_number": "ANDA213118",
  "marketing_category": "ANDA",
  "nonproprietary_name": "carboprost tromethamine",
  "start_marketing_date": "20250515",
  "active_numerator_strength": "250"
}

Related drugs

Other records sharing ATC code G02AD.

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