Neostigmine methylsulfate

In shortageOrange BookUNIISPLATC N07AA

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

Identification

ManufacturerGland Pharma Limited

CountryUS (United States)

ATC codeN07AA

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6808338410
10 CARTON in 1 CARTON (68083-384-10) / 1 VIAL, MULTI-DOSE in 1 CARTON (68083-384-01) / 10 mL in 1 VIAL, MULTI-DOSE

Annotations

UNII (FDA Substance ID)

98IMH7M386

NEOSTIGMINE METHYLSULFATE

RxCUI 7316

Orange Book

A212968

APAP

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": "68083-384_248b2834-6520-42e5-85cd-92c29eb7b804",
  "productndc": "68083-384",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "212968",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "5MG/10ML (0.5MG/ML)",
        "product_no": "001",
        "approval_date": "Oct 16, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "10MG/10ML (1MG/ML)",
        "product_no": "002",
        "approval_date": "Oct 16, 2019"
      }
    ],
    "appl_type": "A"
  },
  "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": "ANDA212968",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Neostigmine methylsulfate",
  "start_marketing_date": "20191021",
  "active_numerator_strength": "1"
}

Related drugs

Other records sharing ATC code N07AA.

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