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United States · US · US:63323-426_d6e2ff8d-838d-4c27-8e73-230548b09d63
Rocuronium
In shortageOrange BookUNIISPLATC M03AC09
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerFresenius Kabi USA, LLC
CountryUS (United States)
ATC codeM03AC09
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11633234260510 VIAL in 1 TRAY (63323-426-05) / 5 mL in 1 VIAL (63323-426-02)
- ndc11633234261010 VIAL in 1 TRAY (63323-426-10) / 10 mL in 1 VIAL (63323-426-01)
Annotations
UNII (FDA Substance ID)
I65MW4OFHZ
ROCURONIUM BROMIDE
RxCUI 32521
Orange Book
A078651
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": "63323-426_d6e2ff8d-838d-4c27-8e73-230548b09d63",
"productndc": "63323-426",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "078651",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "50MG/5ML (10MG/ML)",
"product_no": "001",
"approval_date": "Dec 29, 2008"
},
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "100MG/10ML (10MG/ML)",
"product_no": "002",
"approval_date": "Dec 29, 2008"
}
],
"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",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA078651",
"marketing_category": "ANDA",
"nonproprietary_name": "ROCURONIUM BROMIDE",
"start_marketing_date": "20091213",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code M03AC09.
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