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United States · US · US:43598-529_649d8760-81df-13da-6556-14a0fdbc8b02

Neostigmine

In shortageOrange BookUNIISPLATC N07AA

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

Identification

ManufacturerDr.Reddy's Laboratories Inc
CountryUS (United States)
ATC codeN07AA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    4359852911
    1 VIAL, MULTI-DOSE in 1 CARTON (43598-529-11) / 10 mL in 1 VIAL, MULTI-DOSE
  • ndc11
    4359852936
    10 VIAL, MULTI-DOSE in 1 CARTON (43598-529-36) / 10 mL in 1 VIAL, MULTI-DOSE

Annotations

UNII (FDA Substance ID)
98IMH7M386
NEOSTIGMINE METHYLSULFATE
RxCUI 7316
Orange Book
A209135
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": "43598-529_649d8760-81df-13da-6556-14a0fdbc8b02",
  "productndc": "43598-529",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "209135",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "5MG/10ML (0.5MG/ML)",
        "product_no": "001",
        "approval_date": "Jul 10, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "10MG/10ML (1MG/ML)",
        "product_no": "002",
        "approval_date": "Jul 10, 2018"
      }
    ],
    "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",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA209135",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Neostigmine",
  "start_marketing_date": "20180904",
  "active_numerator_strength": "1"
}

Related drugs

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