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United States · US · US:71839-137_8447d4f1-d286-4aa0-a379-a673518da045

CARBOPROST TROMETHAMINE

Orange BookUNIISPLATC G02AD

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

Identification

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

Packs · 1

  • ndc11
    7183913710
    10 VIAL in 1 CARTON (71839-137-10) / 1 mL in 1 VIAL (71839-137-01)

Annotations

UNII (FDA Substance ID)
U4526F86FJ
CARBOPROST TROMETHAMINE
RxCUI 20259
Orange Book
A216882
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": "71839-137_8447d4f1-d286-4aa0-a379-a673518da045",
  "productndc": "71839-137",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "216882",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 0.25MG BASE/ML",
        "product_no": "001",
        "approval_date": "Feb 13, 2023"
      }
    ],
    "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": "ANDA216882",
  "marketing_category": "ANDA",
  "nonproprietary_name": "carboprost tromethamine",
  "start_marketing_date": "20230511",
  "active_numerator_strength": "250"
}

Related drugs

Other records sharing ATC code G02AD.

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