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United States · US · US:51754-1200_f9ddedaa-a4a1-4fa2-8a3e-a3bb3abdde47

Bloxiverz

In shortageOrange BookUNIISPLATC N07AA

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

Identification

ManufacturerExela Pharma Sciences, LLC
CountryUS (United States)
ATC codeN07AA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5175412003
    10 SYRINGE, PLASTIC in 1 CARTON (51754-1200-3) / 5 mL in 1 SYRINGE, PLASTIC

Annotations

UNII (FDA Substance ID)
98IMH7M386
NEOSTIGMINE METHYLSULFATE
RxCUI 7316
Orange Book
N204078
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Neostigmine Methylsulfate Injection
Raw payload (JSON)
{
  "unii": {
    "unii": "98IMH7M386",
    "rxcui": "7316",
    "inchikey": "OSZNNLWOYWAHSS-UHFFFAOYSA-M",
    "display_name": "NEOSTIGMINE METHYLSULFATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "d2f55643-2b0d-4ef9-a9d8-b7138b314372": {
      "match": "brand_token",
      "title": "BLOXIVERZ (NEOSTIGMINE METHYLSULFATE) INJECTION [EXELA PHARMA SCIENCES, LLC]",
      "spl_version": "18",
      "published_date": "2024-01-17"
    }
  },
  "productid": "51754-1200_f9ddedaa-a4a1-4fa2-8a3e-a3bb3abdde47",
  "productndc": "51754-1200",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "204078",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "5MG/10ML (0.5MG/ML)",
        "product_no": "001",
        "approval_date": "May 31, 2013"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "10MG/10ML (1MG/ML)",
        "product_no": "002",
        "approval_date": "May 31, 2013"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "5MG/5ML (1MG/ML)",
        "product_no": "003",
        "approval_date": "Oct 27, 2023"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "NEOSTIGMINE METHYLSULFATE",
  "shortage_reason": "Neostigmine Methylsulfate Injection",
  "shortage_status": "current",
  "proprietary_name": "Bloxiverz",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA204078",
  "marketing_category": "NDA",
  "nonproprietary_name": "Neostigmine Methylsulfate",
  "start_marketing_date": "20231106",
  "active_numerator_strength": "1"
}

Related drugs

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