Neostigmine Methylsulfate

In shortageOrange BookUNIISPLATC N07AA

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerFresenius Kabi USA, LLC

CountryUS (United States)

ATC codeN07AA

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6521981110
10 VIAL, MULTI-DOSE in 1 TRAY (65219-811-10) / 10 mL in 1 VIAL, MULTI-DOSE (65219-811-01)

Annotations

UNII (FDA Substance ID)

98IMH7M386

NEOSTIGMINE METHYLSULFATE

RxCUI 7316

Orange Book

N203629

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": {
    "7a9d996f-aecb-455f-95fc-1010e461d75d": {
      "match": "brand_token",
      "title": "NEOSTIGMINE METHYLSULFATE INJECTION [HIKMA PHARMACEUTICALS USA INC.]",
      "spl_version": "12",
      "published_date": "2026-03-20"
    }
  },
  "productid": "65219-811_0831f9a8-b6ff-4b49-91ad-8177f968f543",
  "productndc": "65219-811",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "203629",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "5MG/10ML (0.5MG/ML)",
        "product_no": "001",
        "approval_date": "Jan 8, 2015"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "10MG/10ML (1MG/ML)",
        "product_no": "002",
        "approval_date": "Jan 8, 2015"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "3MG/3ML (1MG/ML)",
        "product_no": "003",
        "approval_date": "Sep 18, 2018"
      }
    ],
    "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": "Neostigmine Methylsulfate",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA203629",
  "marketing_category": "NDA",
  "nonproprietary_name": "Neostigmine Methylsulfate",
  "start_marketing_date": "20150108",
  "active_numerator_strength": "1"
}

Related drugs

Other records sharing ATC code N07AA.

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