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United States · US · US:68083-161_b61d560c-02fd-4ae7-a6f7-fa7edb0a0d3f

Mesna

Orange BookUNIISPLATC V03AF01

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

Identification

ManufacturerGland Pharma Limited
CountryUS (United States)
ATC codeV03AF01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    6808316101
    1 VIAL, MULTI-DOSE in 1 CARTON (68083-161-01) / 10 mL in 1 VIAL, MULTI-DOSE
  • ndc11
    6808316110
    10 VIAL, MULTI-DOSE in 1 CARTON (68083-161-10) / 10 mL in 1 VIAL, MULTI-DOSE

Annotations

UNII (FDA Substance ID)
NR7O1405Q9
MESNA
RxCUI 44
Orange Book
A206992
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "NR7O1405Q9",
    "rxcui": "44",
    "inchikey": "XOGTZOOQQBDUSI-UHFFFAOYSA-M",
    "display_name": "MESNA",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "a880160b-fa82-453a-a971-29ab897876a7": {
      "match": "brand_token",
      "title": "MESNA INJECTION, SOLUTION [BAXTER HEALTHCARE COMPANY]",
      "spl_version": "11",
      "published_date": "2026-05-29"
    }
  },
  "productid": "68083-161_b61d560c-02fd-4ae7-a6f7-fa7edb0a0d3f",
  "productndc": "68083-161",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "206992",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "100MG/ML",
        "product_no": "001",
        "approval_date": "Dec 18, 2017"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MESNA",
  "proprietary_name": "Mesna",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA206992",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Mesna Injection",
  "start_marketing_date": "20171220",
  "active_numerator_strength": "100"
}

Related drugs

Other records sharing ATC code V03AF01.

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