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United States · US · US:51754-1029_ed0040fb-c481-4477-8712-00fa6350cd70

NIPRIDE RTU

In shortageOrange BookUNIIATC C02DD

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

Identification

ManufacturerEXELA PHARMA SCIENCES, LLC
CountryUS (United States)
ATC codeC02DD
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5175410291
    1 VIAL in 1 CARTON (51754-1029-1) / 100 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)
EAO03PE1TC
SODIUM NITROPRUSSIDE
RxCUI 9895
Orange Book
N209387
APAP
FDA shortage
Currently in shortage
Sodium Chloride 0.9% Injection
Raw payload (JSON)
{
  "unii": {
    "unii": "EAO03PE1TC",
    "rxcui": "9895",
    "inchikey": "SPBWMYPZWNFWES-UHFFFAOYSA-N",
    "display_name": "SODIUM NITROPRUSSIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "productid": "51754-1029_ed0040fb-c481-4477-8712-00fa6350cd70",
  "productndc": "51754-1029",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "209387",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "50MG/100ML (0.5MG/ML)",
        "product_no": "001",
        "approval_date": "Mar 8, 2017"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "10MG/50ML (0.2MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "002",
        "approval_date": "Dec 7, 2017"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "20MG/100ML (0.2MG/ML)",
        "product_no": "003",
        "approval_date": "Jul 13, 2018"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SODIUM NITROPRUSSIDE",
  "shortage_reason": "Sodium Chloride 0.9% Injection",
  "shortage_status": "current",
  "proprietary_name": "NIPRIDE RTU",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA209387",
  "marketing_category": "NDA",
  "nonproprietary_name": "Sodium Nitroprusside",
  "start_marketing_date": "20180720",
  "active_numerator_strength": ".2"
}

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