FDA.reportPublic FDA data

Rocuronium Bromide

Product NDC
0143-9251
11-digit product format
001439251
Labeler code
0143
Product ID
0143-9251_51fc5473-b651-4c85-83ff-7edc65a6cef2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rocuronium Bromide
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA204679
Marketing category
ANDA
Marketing start
2017-04-30
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
0143-9251-01Rocuronium Bromide10 mL in 1 VIALINJECTION1012
0143-9251-10Rocuronium Bromide10 in 1 BOXINJECTION1012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9251-01ML - Milliliter0143-92516f2c400f-b6ab-41d8-bb19-2743ea937ec212019-08-06
0143-9251-10ML - Milliliter0143-9251575c2b31-e6df-4c4e-91cf-8dea165ea51412019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9251ROCURONIUM BROMIDE INJECTION [HIKMA PHARMACEUTICALS USA INC.]10Current NDC, Legacy NDC, 2 package rows20240322_d3a172a5-01ab-47d8-92ac-a8539b1d4dc4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1234995rocuronium bromide 10 MG/ML Injectable SolutionPSNd3a172a5-01ab-47d8-92ac-a8539b1d4dc412
1234995rocuronium bromide 10 MG/ML Injectable SolutionSCDd3a172a5-01ab-47d8-92ac-a8539b1d4dc412
1234995rocuronium bromide 100 MG per 10 ML Concentrate for Injectable SolutionSYd3a172a5-01ab-47d8-92ac-a8539b1d4dc412
1234995rocuronium bromide 50 MG per 5 ML Concentrate for Injectable SolutionSYd3a172a5-01ab-47d8-92ac-a8539b1d4dc412

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0143-9251-010014392510110 mL in 1 VIAL10 mlHistorical
0143-9251-100014392511010 VIAL in 1 BOX (0143-9251-10) / 10 mL in 1 VIAL (0143-9251-01) 10 vial2017-04-300000-00-00NoNoCurrent