Rocuronium Bromide

In shortageOrange BookUNIISPLATC M03AC09

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

Identification

ManufacturerGland Pharma Limited

CountryUS (United States)

ATC codeM03AC09

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6808336510
10 VIAL, MULTI-DOSE in 1 CARTON (68083-365-10) / 10 mL in 1 VIAL, MULTI-DOSE (68083-365-01)

Annotations

UNII (FDA Substance ID)

I65MW4OFHZ

ROCURONIUM BROMIDE

RxCUI 32521

Orange Book

A205656

APAP

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Rocuronium Bromide Injection

Raw payload (JSON)

{
  "unii": {
    "unii": "I65MW4OFHZ",
    "rxcui": "32521",
    "inchikey": "OYTJKRAYGYRUJK-FMCCZJBLSA-M",
    "display_name": "ROCURONIUM BROMIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "d3a172a5-01ab-47d8-92ac-a8539b1d4dc4": {
      "match": "brand_token",
      "title": "ROCURONIUM BROMIDE INJECTION [HIKMA PHARMACEUTICALS USA INC.]",
      "spl_version": "12",
      "published_date": "2026-05-21"
    }
  },
  "productid": "68083-365_f0786673-741a-4016-9528-268128b3b142",
  "productndc": "68083-365",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "205656",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AP",
        "strength": "50MG/5ML (10MG/ML)",
        "product_no": "001",
        "approval_date": "Apr 4, 2018"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AP",
        "strength": "100MG/10ML (10MG/ML)",
        "product_no": "002",
        "approval_date": "Apr 4, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ROCURONIUM BROMIDE",
  "shortage_reason": "Rocuronium Bromide Injection",
  "shortage_status": "current",
  "proprietary_name": "Rocuronium Bromide",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA205656",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Rocuronium Bromide",
  "start_marketing_date": "20180518",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code M03AC09.

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