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United States · US · US:67457-228_b65fbcab-781e-4706-a60b-a8eb4aeae0c1
Rocuronium Bromide
In shortageOrange BookUNIISPLATC M03AC09
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMylan Institutional LLC
CountryUS (United States)
ATC codeM03AC09
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11674572280510 VIAL, MULTI-DOSE in 1 CARTON (67457-228-05) / 5 mL in 1 VIAL, MULTI-DOSE (67457-228-00)
- ndc11674572281010 VIAL, MULTI-DOSE in 1 CARTON (67457-228-10) / 10 mL in 1 VIAL, MULTI-DOSE (67457-228-99)
Annotations
UNII (FDA Substance ID)
I65MW4OFHZ
ROCURONIUM BROMIDE
RxCUI 32521
Orange Book
A079199
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": "67457-228_b65fbcab-781e-4706-a60b-a8eb4aeae0c1",
"productndc": "67457-228",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "079199",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "50MG/5ML (10MG/ML)",
"product_no": "001",
"approval_date": "Nov 26, 2008"
},
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "100MG/10ML (10MG/ML)",
"product_no": "002",
"approval_date": "Nov 26, 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 Bromide",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA079199",
"marketing_category": "ANDA",
"nonproprietary_name": "rocuronium bromide",
"start_marketing_date": "20120206",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code M03AC09.
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