FDA.reportPublic FDA data

Rocuronium bromide

Product NDC
71479-005
11-digit product format
714790005
Labeler code
71479
Product ID
71479-005_d59a71ae-bd7e-43aa-ae77-fd956573db7c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rocuronium bromide
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Sanovel Ilac San. Ve Tic.A.S.
Application
ANDA210437
Marketing category
ANDA
Marketing start
2019-12-31
Marketing end
0000-00-00
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
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f63639fe-3389-4c7a-8765-a6005a965c6cProduct name920260316

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71479-005-052021-01-29C16284748780-1ba0f9c33-327c-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use ROCURONIUM BROMIDE safely and effectively. See full prescribing information for ROCURONIUM BROMIDE. ROCURONIUM BROMIDE injection solution for intravenous use Initial U.S. Approval: 1994

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71479-005-05Rocuronium bromide5 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION52
71479-005-05Rocuronium bromide10 in 1 BOXINJECTION, SOLUTION102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71479-005ROCURONIUM BROMIDE INJECTION, SOLUTION [SANOVEL ILAC SAN. VE TIC.A.S.]2Legacy NDC, 2 package rows20191231_ba999c24-fe3c-4d8f-981f-17d8639bc16b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1234995rocuronium bromide 10 MG/ML Injectable SolutionPSNba999c24-fe3c-4d8f-981f-17d8639bc16b2
1234995rocuronium bromide 10 MG/ML Injectable SolutionSCDba999c24-fe3c-4d8f-981f-17d8639bc16b2
1234995rocuronium bromide 100 MG per 10 ML Concentrate for Injectable SolutionSYba999c24-fe3c-4d8f-981f-17d8639bc16b2
1234995rocuronium bromide 50 MG per 5 ML Concentrate for Injectable SolutionSYba999c24-fe3c-4d8f-981f-17d8639bc16b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
71479-005-05714790005055 mL in 1 VIAL, MULTI-DOSE5 mlHistorical