Cisatracurium besylate

In shortageOrange BookUNIISPLATC M03AC11

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

Identification

ManufacturerCaplin Steriles Limited

CountryUS (United States)

ATC codeM03AC11

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6514513701
1 VIAL, SINGLE-DOSE in 1 CARTON (65145-137-01) / 20 mL in 1 VIAL, SINGLE-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": "65145-137_984769d6-523a-4e06-aaa7-ccbb039e38ea",
  "productndc": "65145-137",
  "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": "10"
}

Related drugs

Other records sharing ATC code M03AC11.

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