FDA.reportPublic FDA data

Rocuronium Bromide

Product NDC
43066-013
11-digit product format
430660013
Labeler code
43066
Product ID
43066-013_9e0317de-2d78-4fd8-8926-4c7b476f3ed4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rocuronium Bromide
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Baxter Healthcare Corporation
Application
ANDA091115
Marketing category
ANDA
Marketing start
2019-07-15
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
43066-013-10Rocuronium Bromide10 in 1 CARTONINJECTION107
43066-013-10Rocuronium Bromide10 mL in 1 VIALINJECTION107

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43066-013-10ML - Milliliter43066-0137f7a022d-1f0b-486c-939f-0cb5c0dabbdd12019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43066-013ROCURONIUM BROMIDE INJECTION [BAXTER HEALTHCARE CORPORATION]6Current NDC, Legacy NDC, 2 package rows20241017_31e15c3f-aefa-4379-b684-7707744fe40d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1234995rocuronium bromide 10 MG/ML Injectable SolutionPSN31e15c3f-aefa-4379-b684-7707744fe40d7
1234995rocuronium bromide 10 MG/ML Injectable SolutionSCD31e15c3f-aefa-4379-b684-7707744fe40d7
1234995rocuronium bromide 100 MG per 10 ML Concentrate for Injectable SolutionSY31e15c3f-aefa-4379-b684-7707744fe40d7
1234995rocuronium bromide 50 MG per 5 ML Concentrate for Injectable SolutionSY31e15c3f-aefa-4379-b684-7707744fe40d7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43066-013-104306600131010 VIAL in 1 CARTON (43066-013-10) / 10 mL in 1 VIAL10 vial2019-07-150000-00-00NoNoCurrent