Cisatracurium Besylate

Product NDC
0143-9396
11-digit product format
001439396
Labeler code
0143
Product ID
0143-9396_6c1a13e7-546c-4b06-8217-73f2c4b7ed57
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cisatracurium Besylate
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA203078
Marketing category
ANDA
Marketing start
2023-05-31
Substance
CISATRACURIUM BESYLATE
Active strength
2 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
Cisatracurium Besylate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CISATRACURIUM BESYLATE2 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii80YS8O1MBS
Rxcui199212, 1730194

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bde27158-d1b9-e941-8af6-709c63f1bc54Product name920200925

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0143-9396-01Cisatracurium Besylate1 in 1 CARTONINJECTION14
0143-9396-01Cisatracurium Besylate5 mL in 1 VIALINJECTION54

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9396-01ML - Milliliter0143-93967a95990a-be25-4f66-8f0b-640f1913c02112023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9396CISATRACURIUM BESYLATE INJECTION [HIKMA PHARMACEUTICALS USA INC.]4Current NDC, 2 package rows20250516_c5a63679-0c94-4e9d-9ac0-8ee3023bd9a6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1730194cisatracurium besylate 10 MG in 5 ML InjectionPSNc5a63679-0c94-4e9d-9ac0-8ee3023bd9a64
199212cisatracurium besylate 200 MG in 20 ML InjectionPSNc5a63679-0c94-4e9d-9ac0-8ee3023bd9a64
19921220 ML cisatracurium 10 MG/ML InjectionSCDc5a63679-0c94-4e9d-9ac0-8ee3023bd9a64
17301945 ML cisatracurium 2 MG/ML InjectionSCDc5a63679-0c94-4e9d-9ac0-8ee3023bd9a64
1730194cisatracurium (as cisatracurium besylate) 10 MG per 5 ML InjectionSYc5a63679-0c94-4e9d-9ac0-8ee3023bd9a64
199212cisatracurium (as cisatracurium besylate) 200 MG per 20 ML InjectionSYc5a63679-0c94-4e9d-9ac0-8ee3023bd9a64
199212cisatracurium 200 MG per 20 ML InjectionSYc5a63679-0c94-4e9d-9ac0-8ee3023bd9a64

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0143-9396-01001439396011 VIAL in 1 CARTON (0143-9396-01) / 5 mL in 1 VIAL1 vial2023-05-31NoNoCurrent