FDA.reportPublic FDA data

ROCURONIUM BROMIDE

Product NDC
0409-9558
11-digit product format
004099558
Labeler code
0409
Product ID
0409-9558_3e8928e4-d2cc-4fbe-89a0-f04e0f5e08f7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ROCURONIUM BROMIDE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Hospira, Inc.
Application
ANDA078519
Marketing category
ANDA
Marketing start
2008-12-15
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ROCURONIUM BROMIDE
Listing expiration
2027-12-31

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
0409-9558-05Rocuronium Bromide10 in 1 BOXINJECTION, SOLUTION1029
0409-9558-10Rocuronium Bromide10 in 1 BOXINJECTION, SOLUTION1029
0409-9558-11Rocuronium Bromide5 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION529
0409-9558-31Rocuronium Bromide10 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION1029
0409-9558-49ROCURONIUM BROMIDE10 in 1 BOXINJECTION, SOLUTION1014
0409-9558-50ROCURONIUM BROMIDE10 in 1 BOXINJECTION, SOLUTION1014
0409-9558-69ROCURONIUM BROMIDE5 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION514
0409-9558-70ROCURONIUM BROMIDE10 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION1014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-9558-05ML - Milliliter0409-955876ef3541-29b6-4894-b97a-6de05914c0f512012-07-24
0409-9558-10ML - Milliliter0409-95583a085b04-cdb3-4642-8f63-1a0303b04fd212012-07-24
0409-9558-11ML - Milliliter0409-955867418593-3473-4d6a-8e00-203b5591f8e112020-01-03
0409-9558-31ML - Milliliter0409-9558f0a0badc-151a-4891-9f33-c7540517b78312020-02-13
0409-9558-49ML - Milliliter0409-955848aace5d-1ceb-48c5-9487-0aef323e324e12012-07-24
0409-9558-50ML - Milliliter0409-9558d83e760d-a00b-4365-8396-7c46bc261bb512012-07-24
0409-9558-69ML - Milliliter0409-9558b6d4c76a-bde5-41b3-a6ed-d81c4c006b2212020-02-13
0409-9558-70ML - Milliliter0409-955889be01fb-24c3-4f9c-8eb4-ecee46c06c3112020-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ROCURONIUM BROMIDEACTIVE INGREDIENTI65MW4OFHZROCURONIUM BROMIDE INJECTION, SOLUTION [HOSPIRA, INC.]15
ROCURONIUMACTIVE MOIETYWRE554RFEZROCURONIUM BROMIDE INJECTION, SOLUTION [HOSPIRA, INC.]15
ACETIC ACIDINACTIVE INGREDIENTQ40Q9N063PROCURONIUM BROMIDE INJECTION, SOLUTION [HOSPIRA, INC.]15
SODIUM ACETATEINACTIVE INGREDIENT4550K0SC9BROCURONIUM BROMIDE INJECTION, SOLUTION [HOSPIRA, INC.]15
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XROCURONIUM BROMIDE INJECTION, SOLUTION [HOSPIRA, INC.]15
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IROCURONIUM BROMIDE INJECTION, SOLUTION [HOSPIRA, INC.]15
ROCURONIUM BROMIDEACTIVE INGREDIENTI65MW4OFHZROCURONIUM BROMIDE INJECTION, SOLUTION [HOSPIRA, INC.]2
ROCURONIUMACTIVE MOIETYWRE554RFEZROCURONIUM BROMIDE INJECTION, SOLUTION [HOSPIRA, INC.]2
ACETIC ACIDINACTIVE INGREDIENTQ40Q9N063PROCURONIUM BROMIDE INJECTION, SOLUTION [HOSPIRA, INC.]2
SODIUM ACETATEINACTIVE INGREDIENT4550K0SC9BROCURONIUM BROMIDE INJECTION, SOLUTION [HOSPIRA, INC.]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XROCURONIUM BROMIDE INJECTION, SOLUTION [HOSPIRA, INC.]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IROCURONIUM BROMIDE INJECTION, SOLUTION [HOSPIRA, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-9558ROCURONIUM BROMIDE INJECTION, SOLUTION [HOSPIRA, INC.]27Current NDC, Legacy NDC, 4 package rows20241122_309aeb1b-8022-4df7-8194-ae6529e3395c.zip
0409-9558ROCURONIUM BROMIDE INJECTION, SOLUTION [HOSPIRA, INC.]12Current NDC, Legacy NDC, 4 package rows20241122_cccd40ca-5f08-4acb-8548-3cad558388bb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1234995rocuronium bromide 10 MG/ML Injectable SolutionPSN309aeb1b-8022-4df7-8194-ae6529e3395c29
1234995rocuronium bromide 10 MG/ML Injectable SolutionSCD309aeb1b-8022-4df7-8194-ae6529e3395c29
1234995rocuronium bromide 100 MG per 10 ML Concentrate for Injectable SolutionSY309aeb1b-8022-4df7-8194-ae6529e3395c29
1234995rocuronium bromide 50 MG per 5 ML Concentrate for Injectable SolutionSY309aeb1b-8022-4df7-8194-ae6529e3395c29
1234995rocuronium bromide 10 MG/ML Injectable SolutionPSNcccd40ca-5f08-4acb-8548-3cad558388bb14
1234995rocuronium bromide 10 MG/ML Injectable SolutionSCDcccd40ca-5f08-4acb-8548-3cad558388bb14
1234995rocuronium bromide 100 MG per 10 ML Concentrate for Injectable SolutionSYcccd40ca-5f08-4acb-8548-3cad558388bb14
1234995rocuronium bromide 50 MG per 5 ML Concentrate for Injectable SolutionSYcccd40ca-5f08-4acb-8548-3cad558388bb14
1234995rocuronium bromide 10 MG/ML Injectable SolutionPSN81628de9-e6bf-8f69-e053-2991aa0a60235
1234995rocuronium bromide 10 MG/ML Injectable SolutionSCD81628de9-e6bf-8f69-e053-2991aa0a60235
1234995rocuronium bromide 100 MG per 10 ML Concentrate for Injectable SolutionSY81628de9-e6bf-8f69-e053-2991aa0a60235
1234995rocuronium bromide 50 MG per 5 ML Concentrate for Injectable SolutionSY81628de9-e6bf-8f69-e053-2991aa0a60235
1234995rocuronium bromide 10 MG/ML Injectable SolutionPSN818f7cc6-2c3f-1788-e053-2991aa0a4c6a3
1234995rocuronium bromide 10 MG/ML Injectable SolutionSCD818f7cc6-2c3f-1788-e053-2991aa0a4c6a3
1234995rocuronium bromide 100 MG per 10 ML Concentrate for Injectable SolutionSY818f7cc6-2c3f-1788-e053-2991aa0a4c6a3
1234995rocuronium bromide 50 MG per 5 ML Concentrate for Injectable SolutionSY818f7cc6-2c3f-1788-e053-2991aa0a4c6a3
1234995rocuronium bromide 10 MG/ML Injectable SolutionPSN9f68e273-9b0e-99e3-e053-2995a90a02d12
1234995rocuronium bromide 10 MG/ML Injectable SolutionSCD9f68e273-9b0e-99e3-e053-2995a90a02d12
1234995rocuronium bromide 100 MG per 10 ML Concentrate for Injectable SolutionSY9f68e273-9b0e-99e3-e053-2995a90a02d12
1234995rocuronium bromide 50 MG per 5 ML Concentrate for Injectable SolutionSY9f68e273-9b0e-99e3-e053-2995a90a02d12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0409-9558-050040995580510 VIAL, MULTI-DOSE in 1 BOX (0409-9558-05) / 5 mL in 1 VIAL, MULTI-DOSE (0409-9558-11) 2008-12-010000-00-00NoNoCurrent
0409-9558-100040995581010 VIAL, MULTI-DOSE in 1 BOX (0409-9558-10) / 10 mL in 1 VIAL, MULTI-DOSE (0409-9558-31) 2008-12-010000-00-00NoNoCurrent
0409-9558-11004099558115 mL in 1 VIAL, MULTI-DOSE5 mlHistorical
0409-9558-310040995583110 mL in 1 VIAL, MULTI-DOSE10 mlHistorical
0409-9558-490040995584910 VIAL, MULTI-DOSE in 1 BOX (0409-9558-49) / 5 mL in 1 VIAL, MULTI-DOSE (0409-9558-69) 2008-12-150000-00-00NoNoCurrent
0409-9558-500040995585010 VIAL, MULTI-DOSE in 1 BOX (0409-9558-50) / 10 mL in 1 VIAL, MULTI-DOSE (0409-9558-70) 2008-12-150000-00-00NoNoCurrent
0409-9558-69004099558695 mL in 1 VIAL, MULTI-DOSE5 mlHistorical
0409-9558-700040995587010 mL in 1 VIAL, MULTI-DOSE10 mlHistorical