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United States · US · US:39822-4200_eedcfb07-4e23-3152-e053-2995a90a6e6a
rocuronium bromide
In shortageOrange BookUNIISPLATC M03AC09
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerXGen Pharmaceuticals DJB, Inc.
CountryUS (United States)
ATC codeM03AC09
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11398224200210 VIAL in 1 CARTON (39822-4200-2) / 5 mL in 1 VIAL (39822-4200-1)
- ndc11398224200610 VIAL in 1 CARTON (39822-4200-6) / 10 mL in 1 VIAL (39822-4200-5)
Annotations
UNII (FDA Substance ID)
I65MW4OFHZ
ROCURONIUM BROMIDE
RxCUI 32521
Orange Book
A091115
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": "39822-4200_eedcfb07-4e23-3152-e053-2995a90a6e6a",
"productndc": "39822-4200",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "091115",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "50MG/5ML (10MG/ML)",
"product_no": "001",
"approval_date": "Aug 27, 2012"
},
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "100MG/10ML (10MG/ML)",
"product_no": "002",
"approval_date": "Aug 27, 2012"
}
],
"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": "ANDA091115",
"marketing_category": "ANDA",
"nonproprietary_name": "rocuronium bromide",
"start_marketing_date": "20121201",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code M03AC09.
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