Neostigmine Methylsulfate

In shortageOrange BookUNIISPLATC N07AA

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

Identification

ManufacturerHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.

CountryUS (United States)

ATC codeN07AA

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
2315551741
10 VIAL in 1 CARTON (23155-517-41) / 10 mL in 1 VIAL (23155-517-31)

Annotations

UNII (FDA Substance ID)

98IMH7M386

NEOSTIGMINE METHYLSULFATE

RxCUI 7316

Orange Book

A208230

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": "23155-517_fe40568f-ed8b-43fe-987f-839427a5924f",
  "productndc": "23155-517",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "208230",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "5MG/10ML (0.5MG/ML)",
        "product_no": "001",
        "approval_date": "Nov 25, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "10MG/10ML (1MG/ML)",
        "product_no": "002",
        "approval_date": "Nov 25, 2022"
      }
    ],
    "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": "ANDA208230",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Neostigmine Methylsulfate",
  "start_marketing_date": "20221125",
  "active_numerator_strength": ".5"
}

Related drugs

Other records sharing ATC code N07AA.

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