FDA.reportPublic FDA data

Cisatracurium Besylate

Product NDC
0143-9397
11-digit product format
001439397
Labeler code
0143
Product ID
0143-9397_cae2e417-a5d5-447b-a5ce-383f776b6d5e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cisatracurium Besylate
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA203079
Marketing category
ANDA
Marketing start
2025-03-17
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
Rxcui199211

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
0143-9397-01Cisatracurium Besylate10 mL in 1 VIALINJECTION105
0143-9397-10Cisatracurium Besylate10 in 1 CARTONINJECTION105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9397-01ML - Milliliter0143-9397f5bebb37-9b3e-4c1b-a1b5-0b51abb86eab12025-05-14
0143-9397-10ML - Milliliter0143-939738d481f0-b166-47ed-a1f6-ab44b69a4c3812025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9397CISATRACURIUM BESYLATE INJECTION [HIKMA PHARMACEUTICALS USA INC.]5Current NDC, 2 package rows20250516_46c815f6-7a3d-43a3-b470-3377b126ba09.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199211cisatracurium 2 MG/ML Injectable SolutionPSN46c815f6-7a3d-43a3-b470-3377b126ba095
199211cisatracurium 2 MG/ML Injectable SolutionSCD46c815f6-7a3d-43a3-b470-3377b126ba095
199211cisatracurium (as cisatracurium besylate) 2 MG/ML Injectable SolutionSY46c815f6-7a3d-43a3-b470-3377b126ba095

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0143-9397-010014393970110 mL in 1 VIAL10 mlHistorical
0143-9397-100014393971010 VIAL in 1 CARTON (0143-9397-10) / 10 mL in 1 VIAL (0143-9397-01) 10 vial2025-03-17NoNoHistorical