FDA.reportPublic FDA data

Rocuronium

Product NDC
63323-426
11-digit product format
633230426
Labeler code
63323
Product ID
63323-426_3f4d5e11-2c14-4406-8954-04dba2fc65ff
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ROCURONIUM BROMIDE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
ANDA078651
Marketing category
ANDA
Marketing start
2009-12-13
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
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
63323-426-01Rocuronium10 mL in 1 VIALINJECTION, SOLUTION1010
63323-426-02Rocuronium5 mL in 1 VIALINJECTION, SOLUTION510
63323-426-05Rocuronium10 in 1 TRAYINJECTION, SOLUTION1010
63323-426-10Rocuronium10 in 1 TRAYINJECTION, SOLUTION1010
63323-426-12Rocuronium5 mL in 1 VIALINJECTION, SOLUTION52
63323-426-15Rocuronium10 in 1 TRAYINJECTION, SOLUTION102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-426-01ML - Milliliter63323-426d3b9fd6f-b25a-4fc8-8521-c0b4c616780a12021-04-08
63323-426-02ML - Milliliter63323-42658f5ce52-7d7e-4f51-b0b7-c5d104bc091612021-04-08
63323-426-05ML - Milliliter63323-42657d1ef90-49d6-40aa-a48d-bfbe76bf5efd12012-07-24
63323-426-10ML - Milliliter63323-426fd81f695-bfd9-4094-a847-6729e004c2f212012-07-24
63323-426-12ML - Milliliter63323-426f3c58eaf-5bcf-4e84-acee-bf326d44127312023-07-06
63323-426-15ML - Milliliter63323-4261c357adb-ea11-421a-aadc-c401c2789d6412023-07-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ROCURONIUM BROMIDEACTIVE INGREDIENTI65MW4OFHZROCURONIUM (ROCURONIUM BROMIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]3
ROCURONIUMACTIVE MOIETYWRE554RFEZROCURONIUM (ROCURONIUM BROMIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]3
ACETIC ACIDINACTIVE INGREDIENTQ40Q9N063PROCURONIUM (ROCURONIUM BROMIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]3
SODIUM ACETATEINACTIVE INGREDIENT4550K0SC9BROCURONIUM (ROCURONIUM BROMIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]3
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XROCURONIUM (ROCURONIUM BROMIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]3
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IROCURONIUM (ROCURONIUM BROMIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-426ROCURONIUM (ROCURONIUM BROMIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]10Current NDC, Legacy NDC, 4 package rows20230426_f1933332-1ae0-4dc1-be4c-694849e6c9f9.zip
63323-426ROCURONIUM (ROCURONIUM BROMIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2Current NDC, Legacy NDC, 2 package rows20230201_fb9524b2-c353-4747-8954-7ca2529eabb2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1234995rocuronium bromide 10 MG/ML Injectable SolutionPSNf1933332-1ae0-4dc1-be4c-694849e6c9f910
1234995rocuronium bromide 10 MG/ML Injectable SolutionSCDf1933332-1ae0-4dc1-be4c-694849e6c9f910
1234995rocuronium bromide 100 MG per 10 ML Concentrate for Injectable SolutionSYf1933332-1ae0-4dc1-be4c-694849e6c9f910
1234995rocuronium bromide 50 MG per 5 ML Concentrate for Injectable SolutionSYf1933332-1ae0-4dc1-be4c-694849e6c9f910
1234995rocuronium bromide 10 MG/ML Injectable SolutionPSNfb9524b2-c353-4747-8954-7ca2529eabb22
1234995rocuronium bromide 10 MG/ML Injectable SolutionSCDfb9524b2-c353-4747-8954-7ca2529eabb22
1234995rocuronium bromide 100 MG per 10 ML Concentrate for Injectable SolutionSYfb9524b2-c353-4747-8954-7ca2529eabb22
1234995rocuronium bromide 50 MG per 5 ML Concentrate for Injectable SolutionSYfb9524b2-c353-4747-8954-7ca2529eabb22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63323-426-016332304260110 mL in 1 VIAL10 mlHistorical
63323-426-02633230426025 mL in 1 VIAL5 mlHistorical
63323-426-056332304260510 VIAL in 1 TRAY (63323-426-05) / 5 mL in 1 VIAL (63323-426-02) 10 vial2009-12-130000-00-00NoNoCurrent
63323-426-106332304261010 VIAL in 1 TRAY (63323-426-10) / 10 mL in 1 VIAL (63323-426-01) 10 vial2009-12-130000-00-00NoNoCurrent
63323-426-12633230426125 mL in 1 VIAL5 mlHistorical
63323-426-156332304261510 VIAL in 1 TRAY (63323-426-15) / 5 mL in 1 VIAL (63323-426-12) 10 vial2009-12-13NoNoHistorical