FDA.reportPublic FDA data

rocuronium bromide

Product NDC
0409-1403
11-digit product format
004091403
Labeler code
0409
Product ID
0409-1403_f01f9986-43f9-40e8-9506-11bfe78f9242
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
rocuronium bromide
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Hospira, Inc.
Application
ANDA205656
Marketing category
ANDA
Marketing start
2023-08-28
Substance
ROCURONIUM BROMIDE
Active strength
10 mg/mL
Pharmacologic classes
Neuromuscular Nondepolarizing Blockade [PE], Nondepolarizing Neuromuscular Blocker [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
rocuronium bromide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ROCURONIUM BROMIDE10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiI65MW4OFHZ
Rxcui1234995

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f63639fe-3389-4c7a-8765-a6005a965c6cProduct name920260316
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
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
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0409-1403-05rocuronium bromide5 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION51
0409-1403-10rocuronium bromide10 in 1 CARTONINJECTION, SOLUTION101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-1403ROCURONIUM BROMIDE INJECTION, SOLUTION [HOSPIRA, INC.]1Current NDC, 2 package rows20230910_f01f9986-43f9-40e8-9506-11bfe78f9242.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1234995rocuronium bromide 10 MG/ML Injectable SolutionPSNf01f9986-43f9-40e8-9506-11bfe78f92421
1234995rocuronium bromide 10 MG/ML Injectable SolutionSCDf01f9986-43f9-40e8-9506-11bfe78f92421
1234995rocuronium bromide 100 MG per 10 ML Concentrate for Injectable SolutionSYf01f9986-43f9-40e8-9506-11bfe78f92421
1234995rocuronium bromide 50 MG per 5 ML Concentrate for Injectable SolutionSYf01f9986-43f9-40e8-9506-11bfe78f92421

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0409-1403-05004091403055 mL in 1 VIAL, MULTI-DOSE5 mlHistorical
0409-1403-100040914031010 VIAL, MULTI-DOSE in 1 CARTON (0409-1403-10) / 5 mL in 1 VIAL, MULTI-DOSE (0409-1403-05) 2023-08-28NoNoCurrent