FDA.reportPublic FDA data

Cisatracurium Besylate

Product NDC
55150-284
11-digit product format
551500284
Labeler code
55150
Product ID
55150-284_d40d8c7d-32a9-4518-9043-766790c1037c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cisatracurium Besylate
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Eugia US LLC
Application
ANDA209665
Marketing category
ANDA
Marketing start
2020-10-27
Substance
CISATRACURIUM BESYLATE
Active strength
10 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
Cisatracurium Besylate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CISATRACURIUM BESYLATE10 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii80YS8O1MBS
Rxcui199211, 1730194

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bde27158-d1b9-e941-8af6-709c63f1bc54Product name920200925
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55150-284-01Cisatracurium Besylate5 mL in 1 VIAL, SINGLE-DOSEINJECTION56
55150-284-10Cisatracurium Besylate10 in 1 CARTONINJECTION106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55150-284-01ML - Milliliter55150-284891e7428-9a10-4927-80cf-5d13c5cfc1df12021-01-08
55150-284-10ML - Milliliter55150-2841078f8ff-1dda-4d71-a724-52445ec8d2ab12021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55150-284CISATRACURIUM BESYLATE INJECTION [EUGIA US LLC]5Current NDC, Legacy NDC, 2 package rows20240515_2cb05c7e-6228-4e2d-a270-7659e3db3fa7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199211cisatracurium 2 MG/ML Injectable SolutionPSN2cb05c7e-6228-4e2d-a270-7659e3db3fa76
1730194cisatracurium besylate 10 MG in 5 ML InjectionPSN2cb05c7e-6228-4e2d-a270-7659e3db3fa76
17301945 ML cisatracurium 2 MG/ML InjectionSCD2cb05c7e-6228-4e2d-a270-7659e3db3fa76
199211cisatracurium 2 MG/ML Injectable SolutionSCD2cb05c7e-6228-4e2d-a270-7659e3db3fa76
1730194cisatracurium (as cisatracurium besylate) 10 MG per 5 ML InjectionSY2cb05c7e-6228-4e2d-a270-7659e3db3fa76
199211cisatracurium (as cisatracurium besylate) 2 MG/ML Injectable SolutionSY2cb05c7e-6228-4e2d-a270-7659e3db3fa76

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55150-284-01551500284015 mL in 1 VIAL, SINGLE-DOSE5 mlHistorical
55150-284-105515002841010 VIAL, SINGLE-DOSE in 1 CARTON (55150-284-10) / 5 mL in 1 VIAL, SINGLE-DOSE (55150-284-01) 2020-10-270000-00-00NoNoCurrent