FDA.reportPublic FDA data

Rocuronium Bromide

Product NDC
0781-3220
11-digit product format
007813220
Labeler code
0781
Product ID
0781-3220_eaf32464-7950-434a-e053-2a95a90aa2dc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rocuronium Bromide
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Sandoz Inc
Application
ANDA079195
Marketing category
ANDA
Marketing start
2008-12-05
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
0781-3220-70Rocuronium Bromide10 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION1024
0781-3220-75Rocuronium Bromide5 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION524
0781-3220-92Rocuronium Bromide10 in 1 CARTONINJECTION, SOLUTION1024
0781-3220-95Rocuronium Bromide10 in 1 CARTONINJECTION, SOLUTION1024

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-3220-70ML - Milliliter0781-3220d61e753f-9230-460b-9c91-d2938e3ac97712012-07-24
0781-3220-75ML - Milliliter0781-3220cbd1a4e5-a7e9-4142-9892-2b013031cb0712012-07-24
0781-3220-92ML - Milliliter0781-3220e340d3a0-ad9c-4e5a-a695-53d8b9cbc3ed12012-07-24
0781-3220-95ML - Milliliter0781-322064808b12-1df8-4bc2-8dbe-9b468a5e34a512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ROCURONIUM BROMIDEACTIVE INGREDIENTI65MW4OFHZROCURONIUM BROMIDE INJECTION, SOLUTION [SANDOZ INC]14
ROCURONIUMACTIVE MOIETYWRE554RFEZROCURONIUM BROMIDE INJECTION, SOLUTION [SANDOZ INC]14
ACETIC ACIDINACTIVE INGREDIENTQ40Q9N063PROCURONIUM BROMIDE INJECTION, SOLUTION [SANDOZ INC]14
SODIUM ACETATEINACTIVE INGREDIENT4550K0SC9BROCURONIUM BROMIDE INJECTION, SOLUTION [SANDOZ INC]14
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XROCURONIUM BROMIDE INJECTION, SOLUTION [SANDOZ INC]14
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IROCURONIUM BROMIDE INJECTION, SOLUTION [SANDOZ INC]14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-3220ROCURONIUM BROMIDE INJECTION, SOLUTION [SANDOZ INC]24Current NDC, Legacy NDC, 4 package rows20221014_cb28d869-6510-4402-9462-f6bb25fa0fa8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1234995rocuronium bromide 10 MG/ML Injectable SolutionPSNcb28d869-6510-4402-9462-f6bb25fa0fa824
1234995rocuronium bromide 10 MG/ML Injectable SolutionSCDcb28d869-6510-4402-9462-f6bb25fa0fa824
1234995rocuronium bromide 100 MG per 10 ML Concentrate for Injectable SolutionSYcb28d869-6510-4402-9462-f6bb25fa0fa824
1234995rocuronium bromide 50 MG per 5 ML Concentrate for Injectable SolutionSYcb28d869-6510-4402-9462-f6bb25fa0fa824

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0781-3220-700078132207010 mL in 1 VIAL, MULTI-DOSE10 mlHistorical
0781-3220-75007813220755 mL in 1 VIAL, MULTI-DOSE5 mlHistorical
0781-3220-920078132209210 VIAL, MULTI-DOSE in 1 CARTON (0781-3220-92) / 10 mL in 1 VIAL, MULTI-DOSE (0781-3220-70) 2008-12-050000-00-00NoNoCurrent
0781-3220-950078132209510 VIAL, MULTI-DOSE in 1 CARTON (0781-3220-95) / 5 mL in 1 VIAL, MULTI-DOSE (0781-3220-75) 2008-12-050000-00-00NoNoCurrent