FDA.reportPublic FDA data

ROCURONIUM BROMIDE

Product NDC
43547-531
11-digit product format
435470531
Labeler code
43547
Product ID
43547-531_e926b7a9-5f03-47c4-a7d0-2780b01a34c5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
rocuronium bromide
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Solco Healthcare US, LLC
Application
ANDA212668
Marketing category
ANDA
Marketing start
2021-07-25
Substance
ROCURONIUM BROMIDE
Active strength
100 mg/10mL
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 BROMIDE100 mg/10mL

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
43547-531-01ROCURONIUM BROMIDE10 mL in 1 VIAL, MULTI-DOSEINJECTION103
43547-531-10ROCURONIUM BROMIDE10 in 1 CARTONINJECTION103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43547-531-01ML - Milliliter43547-5313b719bf5-2ee6-441c-ad24-bf116b3285a512023-03-13
43547-531-10ML - Milliliter43547-531293edf60-32b4-4d58-b048-cb7fb72a0d6312023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43547-531ROCURONIUM BROMIDE INJECTION [SOLCO HEALTHCARE US, LLC]1Current NDC, Legacy NDC, 2 package rows20220619_b7fba679-9c2d-4dac-af53-8c1331c966c3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1234995rocuronium bromide 10 MG/ML Injectable SolutionPSNb7fba679-9c2d-4dac-af53-8c1331c966c33
1234995rocuronium bromide 10 MG/ML Injectable SolutionSCDb7fba679-9c2d-4dac-af53-8c1331c966c33
1234995rocuronium bromide 100 MG per 10 ML Concentrate for Injectable SolutionSYb7fba679-9c2d-4dac-af53-8c1331c966c33
1234995rocuronium bromide 50 MG per 5 ML Concentrate for Injectable SolutionSYb7fba679-9c2d-4dac-af53-8c1331c966c33

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43547-531-014354705310110 mL in 1 VIAL, MULTI-DOSE10 mlHistorical
43547-531-104354705311010 VIAL, MULTI-DOSE in 1 CARTON (43547-531-10) / 10 mL in 1 VIAL, MULTI-DOSE (43547-531-01) 2021-07-250000-00-00NoNoCurrent