FDA.reportPublic FDA data

ROCURONIUM BROMIDE

Product NDC
65145-130
11-digit product format
651450130
Labeler code
65145
Product ID
65145-130_7196a63c-b610-474e-8119-bcb37e909e1e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ROCURONIUM BROMIDE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Caplin Steriles Limited
Application
ANDA216234
Marketing category
ANDA
Marketing start
2024-10-03
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
65145-130-01ROCURONIUM BROMIDE5 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION54
65145-130-10ROCURONIUM BROMIDE10 in 1 CARTONINJECTION, SOLUTION104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65145-130-01ML - Milliliter65145-1300ea7364e-808b-4e1d-ab6d-2292d766e6ea12024-10-04
65145-130-10ML - Milliliter65145-130d8d681a1-8cd4-4bcd-8008-c657a5e449bb12024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65145-130ROCURONIUM BROMIDE INJECTION, SOLUTION [CAPLIN STERILES LIMITED]4Current NDC, 2 package rows20241004_f1794318-b058-4254-97b7-d4e07126efbb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1234995rocuronium bromide 10 MG/ML Injectable SolutionPSNf1794318-b058-4254-97b7-d4e07126efbb4
1234995rocuronium bromide 10 MG/ML Injectable SolutionSCDf1794318-b058-4254-97b7-d4e07126efbb4
1234995rocuronium bromide 100 MG per 10 ML Concentrate for Injectable SolutionSYf1794318-b058-4254-97b7-d4e07126efbb4
1234995rocuronium bromide 50 MG per 5 ML Concentrate for Injectable SolutionSYf1794318-b058-4254-97b7-d4e07126efbb4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65145-130-01651450130015 mL in 1 VIAL, MULTI-DOSE5 mlHistorical
65145-130-106514501301010 VIAL, MULTI-DOSE in 1 CARTON (65145-130-10) / 5 mL in 1 VIAL, MULTI-DOSE (65145-130-01) 2024-10-03NoNoCurrent