Rocuronium Bromide

Product NDC
67457-228
11-digit product format
674570228
Labeler code
67457
Product ID
67457-228_b65fbcab-781e-4706-a60b-a8eb4aeae0c1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
rocuronium bromide
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Mylan Institutional LLC
Application
ANDA079199
Marketing category
ANDA
Marketing start
2012-02-06
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
67457-228-00Rocuronium Bromide5 mL in 1 VIAL, MULTI-DOSEINJECTION519
67457-228-05Rocuronium Bromide10 in 1 CARTONINJECTION1019
67457-228-10Rocuronium Bromide10 in 1 CARTONINJECTION1019
67457-228-99Rocuronium Bromide10 mL in 1 VIAL, MULTI-DOSEINJECTION1019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67457-228-00ML - Milliliter67457-228c38710d8-fab9-4f8f-9c37-72de92bea21512014-01-04
67457-228-05ML - Milliliter67457-228b21188ba-3785-4775-9a26-4e540be7a7c812012-07-24
67457-228-10ML - Milliliter67457-22801f8565f-978a-4f2f-8271-caf70fca38f612012-07-24
67457-228-99ML - Milliliter67457-228de88ca13-4b81-40c6-860b-367041759e7312014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ROCURONIUM BROMIDEACTIVE INGREDIENTI65MW4OFHZROCURONIUM BROMIDE INJECTION [MYLAN INSTITUTIONAL LLC]11
ROCURONIUMACTIVE MOIETYWRE554RFEZROCURONIUM BROMIDE INJECTION [MYLAN INSTITUTIONAL LLC]11
ACETIC ACIDINACTIVE INGREDIENTQ40Q9N063PROCURONIUM BROMIDE INJECTION [MYLAN INSTITUTIONAL LLC]11
SODIUM ACETATEINACTIVE INGREDIENT4550K0SC9BROCURONIUM BROMIDE INJECTION [MYLAN INSTITUTIONAL LLC]11
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XROCURONIUM BROMIDE INJECTION [MYLAN INSTITUTIONAL LLC]11
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IROCURONIUM BROMIDE INJECTION [MYLAN INSTITUTIONAL LLC]11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67457-228ROCURONIUM BROMIDE INJECTION [MYLAN INSTITUTIONAL LLC]17Current NDC, Legacy NDC, 4 package rows20210817_f58803b0-f173-4997-b2f8-0f415b94dacf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1234995rocuronium bromide 10 MG/ML Injectable SolutionPSNf58803b0-f173-4997-b2f8-0f415b94dacf19
1234995rocuronium bromide 10 MG/ML Injectable SolutionSCDf58803b0-f173-4997-b2f8-0f415b94dacf19
1234995rocuronium bromide 100 MG per 10 ML Concentrate for Injectable SolutionSYf58803b0-f173-4997-b2f8-0f415b94dacf19
1234995rocuronium bromide 50 MG per 5 ML Concentrate for Injectable SolutionSYf58803b0-f173-4997-b2f8-0f415b94dacf19

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67457-228-00674570228005 mL in 1 VIAL, MULTI-DOSE5 mlHistorical
67457-228-056745702280510 VIAL, MULTI-DOSE in 1 CARTON (67457-228-05) / 5 mL in 1 VIAL, MULTI-DOSE (67457-228-00) 2012-02-060000-00-00NoNoCurrent
67457-228-106745702281010 VIAL, MULTI-DOSE in 1 CARTON (67457-228-10) / 10 mL in 1 VIAL, MULTI-DOSE (67457-228-99) 2012-02-060000-00-00NoNoCurrent
67457-228-996745702289910 mL in 1 VIAL, MULTI-DOSE10 mlHistorical