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United States · US · US:65145-136_984769d6-523a-4e06-aaa7-ccbb039e38ea

Cisatracurium besylate

In shortageOrange BookUNIISPLATC M03AC11

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

Identification

ManufacturerCaplin Steriles Limited
CountryUS (United States)
ATC codeM03AC11
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    6514513601
    1 VIAL, MULTI-DOSE in 1 CARTON (65145-136-01) / 10 mL in 1 VIAL, MULTI-DOSE
  • ndc11
    6514513610
    10 VIAL, MULTI-DOSE in 1 CARTON (65145-136-10) / 10 mL in 1 VIAL, MULTI-DOSE

Annotations

UNII (FDA Substance ID)
80YS8O1MBS
CISATRACURIUM BESYLATE
RxCUI 136561
Orange Book
A217725
APAP
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Cisatracurium Besylate Injection
Raw payload (JSON)
{
  "unii": {
    "unii": "80YS8O1MBS",
    "rxcui": "136561",
    "inchikey": "XXZSQOVSEBAPGS-DONVQRBFSA-L",
    "display_name": "CISATRACURIUM BESYLATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "67908e20-044d-454d-9c51-bf106e817bd0": {
      "match": "brand_token",
      "title": "CISATRACURIUM BESYLATE INJECTION, SOLUTION [HOSPIRA, INC.]",
      "spl_version": "15",
      "published_date": "2026-05-28"
    }
  },
  "productid": "65145-136_984769d6-523a-4e06-aaa7-ccbb039e38ea",
  "productndc": "65145-136",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "217725",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 2MG BASE/ML",
        "product_no": "001",
        "approval_date": "Jun 9, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 10MG BASE/ML",
        "product_no": "002",
        "approval_date": "Jun 9, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CISATRACURIUM BESYLATE",
  "shortage_reason": "Cisatracurium Besylate Injection",
  "shortage_status": "current",
  "proprietary_name": "Cisatracurium besylate",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA217725",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Cisatracurium besylate",
  "start_marketing_date": "20250117",
  "active_numerator_strength": "2"
}

Related drugs

Other records sharing ATC code M03AC11.

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