FDA.reportPublic FDA data

Rocuronium Bromide

Product NDC
72572-650
11-digit product format
725720650
Labeler code
72572
Product ID
72572-650_7b89bd0a-9fe9-426c-b0c7-d08b9bf2269c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rocuronium Bromide
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Civica, Inc.
Application
ANDA204679
Marketing category
ANDA
Marketing start
2020-12-16
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
72572-650-01Rocuronium Bromide5 mL in 1 VIALINJECTION57
72572-650-10Rocuronium Bromide10 in 1 CARTONINJECTION107

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72572-650-01ML - Milliliter72572-6505e7e6a08-ebab-4912-8b63-f65ebc39ed7d12021-01-08
72572-650-10ML - Milliliter72572-650e6614222-a47c-4260-967c-633d2aa76d3112021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72572-650ROCURONIUM BROMIDE INJECTION [CIVICA, INC.]6Current NDC, Legacy NDC, 2 package rows20250418_8ea475c7-d35e-47f4-8955-0df5ccd35b79.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1234995rocuronium bromide 10 MG/ML Injectable SolutionPSN8ea475c7-d35e-47f4-8955-0df5ccd35b797
1234995rocuronium bromide 10 MG/ML Injectable SolutionSCD8ea475c7-d35e-47f4-8955-0df5ccd35b797
1234995rocuronium bromide 100 MG per 10 ML Concentrate for Injectable SolutionSY8ea475c7-d35e-47f4-8955-0df5ccd35b797
1234995rocuronium bromide 50 MG per 5 ML Concentrate for Injectable SolutionSY8ea475c7-d35e-47f4-8955-0df5ccd35b797

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72572-650-01725720650015 mL in 1 VIAL5 mlHistorical
72572-650-107257206501010 VIAL in 1 CARTON (72572-650-10) / 5 mL in 1 VIAL (72572-650-01) 10 vial2020-12-160000-00-00NoNoCurrent