FDA.reportPublic FDA data

Cisatracurium Besylate

Product NDC
31722-312
11-digit product format
317220312
Labeler code
31722
Product ID
31722-312_da5bd5ef-99b7-449c-8b59-bb9eb2540d62
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cisatracurium Besylate
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Camber Pharmaceuticals Inc.
Application
ANDA212432
Marketing category
ANDA
Marketing start
2026-05-04
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cisatracurium Besylate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CISATRACURIUM BESYLATE10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii80YS8O1MBS
Rxcui199211, 199212, 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
31722-312-02Cisatracurium Besylate20 mL in 1 VIAL, SINGLE-DOSEINJECTION202
31722-312-10Cisatracurium Besylate10 in 1 CARTONINJECTION102

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199211cisatracurium 2 MG/ML Injectable SolutionPSNd8b5eb77-b393-4cd7-86c5-d2a9d131f96d2
1730194cisatracurium besylate 10 MG in 5 ML InjectionPSNd8b5eb77-b393-4cd7-86c5-d2a9d131f96d2
199212cisatracurium besylate 200 MG in 20 ML InjectionPSNd8b5eb77-b393-4cd7-86c5-d2a9d131f96d2
19921220 ML cisatracurium 10 MG/ML InjectionSCDd8b5eb77-b393-4cd7-86c5-d2a9d131f96d2
17301945 ML cisatracurium 2 MG/ML InjectionSCDd8b5eb77-b393-4cd7-86c5-d2a9d131f96d2
199211cisatracurium 2 MG/ML Injectable SolutionSCDd8b5eb77-b393-4cd7-86c5-d2a9d131f96d2
1730194cisatracurium (as cisatracurium besylate) 10 MG per 5 ML InjectionSYd8b5eb77-b393-4cd7-86c5-d2a9d131f96d2
199211cisatracurium (as cisatracurium besylate) 2 MG/ML Injectable SolutionSYd8b5eb77-b393-4cd7-86c5-d2a9d131f96d2
199212cisatracurium (as cisatracurium besylate) 200 MG per 20 ML InjectionSYd8b5eb77-b393-4cd7-86c5-d2a9d131f96d2
199212cisatracurium 200 MG per 20 ML InjectionSYd8b5eb77-b393-4cd7-86c5-d2a9d131f96d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
31722-312-023172203120220 mL in 1 VIAL, SINGLE-DOSE20 mlHistorical
31722-312-103172203121010 VIAL, SINGLE-DOSE in 1 CARTON (31722-312-10) / 20 mL in 1 VIAL, SINGLE-DOSE (31722-312-02) 2026-05-04NoNoHistorical