FDA.reportPublic FDA data

Rocuronium

Product NDC
66794-228
11-digit product format
667940228
Labeler code
66794
Product ID
66794-228_3f9e12e4-d3c5-fba6-e063-6294a90a7fd6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rocuronium
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Piramal Critical Care Inc
Application
ANDA210437
Marketing category
ANDA
Marketing start
2020-07-20
Substance
ROCURONIUM BROMIDE
Active strength
50 mg/5mL
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ROCURONIUM BROMIDE50 mg/5mL

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
66794-228-02Rocuronium5 mL in 1 VIALINJECTION, SOLUTION59
66794-228-41Rocuronium10 in 1 CARTONINJECTION, SOLUTION109

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66794-228-02ML - Milliliter66794-2283c139b3e-35a7-4e82-97f3-b474fe2786a512020-08-06
66794-228-41ML - Milliliter66794-2283aa630e6-9916-4996-93d6-a9786bc6c84f12020-07-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66794-228ROCURONIUM INJECTION, SOLUTION [PIRAMAL CRITICAL CARE INC]8Current NDC, Legacy NDC, 2 package rows20231222_98255b70-51f9-8d16-e053-2995a90a8f97.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1234995rocuronium bromide 10 MG/ML Injectable SolutionPSN6045ed5a-5d2c-4f17-aaba-458fbf87e85c101
1234995rocuronium bromide 10 MG/ML Injectable SolutionSCD6045ed5a-5d2c-4f17-aaba-458fbf87e85c101
1234995rocuronium bromide 100 MG per 10 ML Concentrate for Injectable SolutionSY6045ed5a-5d2c-4f17-aaba-458fbf87e85c101
1234995rocuronium bromide 50 MG per 5 ML Concentrate for Injectable SolutionSY6045ed5a-5d2c-4f17-aaba-458fbf87e85c101
1234995rocuronium bromide 10 MG/ML Injectable SolutionPSN98255b70-51f9-8d16-e053-2995a90a8f979
1234995rocuronium bromide 10 MG/ML Injectable SolutionSCD98255b70-51f9-8d16-e053-2995a90a8f979
1234995rocuronium bromide 100 MG per 10 ML Concentrate for Injectable SolutionSY98255b70-51f9-8d16-e053-2995a90a8f979
1234995rocuronium bromide 50 MG per 5 ML Concentrate for Injectable SolutionSY98255b70-51f9-8d16-e053-2995a90a8f979

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66794-228-02667940228025 mL in 1 VIAL5 mlHistorical
66794-228-416679402284110 VIAL in 1 CARTON (66794-228-41) / 5 mL in 1 VIAL (66794-228-02) 10 vial2020-07-200000-00-00NoNoCurrent