FDA.reportPublic FDA data

Cisatracurium besylate

Product NDC
68083-487
11-digit product format
680830487
Labeler code
68083
Product ID
68083-487_773f0b75-fafa-439a-b4a3-ca4d2d65eabd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cisatracurium besylate
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Gland Pharma Limited
Application
ANDA215516
Marketing category
ANDA
Marketing start
2025-03-19
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
Rxcui199211, 199212, 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
68083-487-01Cisatracurium besylate20 mL in 1 VIAL, SINGLE-DOSEINJECTION204
68083-487-01Cisatracurium besylate1 in 1 CARTONINJECTION14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68083-487CISATRACURIUM BESYLATE INJECTION [GLAND PHARMA LIMITED]4Current NDC, 2 package rows20250411_0bacc37a-5e7f-4f05-9206-56fc8041c1ad.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199211cisatracurium 2 MG/ML Injectable SolutionPSN0bacc37a-5e7f-4f05-9206-56fc8041c1ad4
1730194cisatracurium besylate 10 MG in 5 ML InjectionPSN0bacc37a-5e7f-4f05-9206-56fc8041c1ad4
199212cisatracurium besylate 200 MG in 20 ML InjectionPSN0bacc37a-5e7f-4f05-9206-56fc8041c1ad4
19921220 ML cisatracurium 10 MG/ML InjectionSCD0bacc37a-5e7f-4f05-9206-56fc8041c1ad4
17301945 ML cisatracurium 2 MG/ML InjectionSCD0bacc37a-5e7f-4f05-9206-56fc8041c1ad4
199211cisatracurium 2 MG/ML Injectable SolutionSCD0bacc37a-5e7f-4f05-9206-56fc8041c1ad4
1730194cisatracurium (as cisatracurium besylate) 10 MG per 5 ML InjectionSY0bacc37a-5e7f-4f05-9206-56fc8041c1ad4
199211cisatracurium (as cisatracurium besylate) 2 MG/ML Injectable SolutionSY0bacc37a-5e7f-4f05-9206-56fc8041c1ad4
199212cisatracurium (as cisatracurium besylate) 200 MG per 20 ML InjectionSY0bacc37a-5e7f-4f05-9206-56fc8041c1ad4
199212cisatracurium 200 MG per 20 ML InjectionSY0bacc37a-5e7f-4f05-9206-56fc8041c1ad4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68083-487-01680830487011 VIAL, SINGLE-DOSE in 1 CARTON (68083-487-01) / 20 mL in 1 VIAL, SINGLE-DOSE2025-03-19NoNoHistorical