FDA.reportPublic FDA data

Cisatracurium Besylate

Product NDC
0143-9160
11-digit product format
001439160
Labeler code
0143
Product ID
0143-9160_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
2025-03-17
Substance
CISATRACURIUM BESYLATE
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
Cisatracurium Besylate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CISATRACURIUM BESYLATE10 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
0143-9160-01Cisatracurium Besylate20 mL in 1 VIALINJECTION204
0143-9160-10Cisatracurium Besylate10 in 1 CARTONINJECTION104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9160-01ML - Milliliter0143-9160db88e81e-bf1d-4e51-b1f1-cb3d6cd5043c12025-05-14
0143-9160-10ML - Milliliter0143-916075120738-a400-441e-8759-5f8832884a5112025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9160CISATRACURIUM 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
0143-9160-010014391600120 mL in 1 VIAL20 mlHistorical
0143-9160-100014391601010 VIAL in 1 CARTON (0143-9160-10) / 20 mL in 1 VIAL (0143-9160-01) 10 vial2025-03-17NoNoHistorical