Rocuronium Bromide

Product NDC
0264-5711
11-digit product format
002645711
Labeler code
0264
Product ID
0264-5711_123bd8e8-648e-4c54-907e-551ffd32643d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rocuronium Bromide
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
B. Braun Medical Inc.
Application
NDA219108
Marketing category
NDA
Marketing start
2026-04-24
Substance
ROCURONIUM BROMIDE
Active strength
50 mg/5mL
Pharmacologic classes
Neuromuscular Nondepolarizing Blockade [PE], Nondepolarizing Neuromuscular Blocker [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Rocuronium Bromide
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ROCURONIUM BROMIDE50 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiI65MW4OFHZ
Rxcui2740933

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f63639fe-3389-4c7a-8765-a6005a965c6cProduct name920260316
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0264-5711-01Rocuronium Bromide5 mL in 1 SYRINGEINJECTION53
0264-5711-10Rocuronium Bromide30 in 1 CASEINJECTION303
0264-5711-10Rocuronium Bromide10 in 1 CARTONINJECTION103

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2740933rocuronium bromide 50 MG in 5 ML Prefilled SyringePSNa54a79f7-5207-43d8-a139-7d57557caa503
27409335 ML rocuronium bromide 10 MG/ML Prefilled SyringeSCDa54a79f7-5207-43d8-a139-7d57557caa503
2740933rocuronium bromide 50 MG per 5 ML Prefilled SyringeSYa54a79f7-5207-43d8-a139-7d57557caa503

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0264-5711-01002645711015 mL in 1 SYRINGE5 mlHistorical
0264-5711-100026457111030 CARTON in 1 CASE (0264-5711-10) / 10 SYRINGE in 1 CARTON / 5 mL in 1 SYRINGE (0264-5711-01) 30 carton2026-04-24NoNoCurrent