FDA.reportPublic FDA data

Cisatracurium Besylate

Product NDC
71288-712
11-digit product format
712880712
Labeler code
71288
Product ID
71288-712_c603acf5-af33-479a-8986-fbceb96ff1e5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cisatracurium Besylate
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Meitheal Pharmaceuticals Inc.
Application
ANDA211668
Marketing category
ANDA
Marketing start
2019-10-31
Substance
CISATRACURIUM BESYLATE
Active strength
10 mg/5mL
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/5mL

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
71288-712-05Cisatracurium Besylate5 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION56
71288-712-06Cisatracurium Besylate10 in 1 CARTONINJECTION, SOLUTION106
71288-712-95Cisatracurium Besylate5 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION51
71288-712-96Cisatracurium Besylate10 in 1 CARTONINJECTION, SOLUTION101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71288-712-05ML - Milliliter71288-71225c5ecc0-7bb7-4ff4-8438-74942a288c7e12020-01-03
71288-712-06ML - Milliliter71288-712289e5d9c-0e70-4ab3-9e65-1f470824d92b12020-01-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71288-712CISATRACURIUM BESYLATE INJECTION, SOLUTION [MEITHEAL PHARMACEUTICALS INC.]6Current NDC, Legacy NDC, 2 package rows20230217_7c8c41b6-d07c-4740-84b7-603289104c59.zip
71288-712CISATRACURIUM BESYLATE INJECTION, SOLUTION [MEITHEAL PHARMACEUTICALS INC.]1Current NDC, Legacy NDC, 2 package rows20230607_1be30efe-4beb-411a-bf82-6e4ea68fd262.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199211cisatracurium 2 MG/ML Injectable SolutionPSN7c8c41b6-d07c-4740-84b7-603289104c596
1730194cisatracurium besylate 10 MG in 5 ML InjectionPSN7c8c41b6-d07c-4740-84b7-603289104c596
199212cisatracurium besylate 200 MG in 20 ML InjectionPSN7c8c41b6-d07c-4740-84b7-603289104c596
19921220 ML cisatracurium 10 MG/ML InjectionSCD7c8c41b6-d07c-4740-84b7-603289104c596
17301945 ML cisatracurium 2 MG/ML InjectionSCD7c8c41b6-d07c-4740-84b7-603289104c596
199211cisatracurium 2 MG/ML Injectable SolutionSCD7c8c41b6-d07c-4740-84b7-603289104c596
1730194cisatracurium (as cisatracurium besylate) 10 MG per 5 ML InjectionSY7c8c41b6-d07c-4740-84b7-603289104c596
199211cisatracurium (as cisatracurium besylate) 2 MG/ML Injectable SolutionSY7c8c41b6-d07c-4740-84b7-603289104c596
199212cisatracurium (as cisatracurium besylate) 200 MG per 20 ML InjectionSY7c8c41b6-d07c-4740-84b7-603289104c596
199212cisatracurium 200 MG per 20 ML InjectionSY7c8c41b6-d07c-4740-84b7-603289104c596
199211cisatracurium 2 MG/ML Injectable SolutionPSN1be30efe-4beb-411a-bf82-6e4ea68fd2621
1730194cisatracurium besylate 10 MG in 5 ML InjectionPSN1be30efe-4beb-411a-bf82-6e4ea68fd2621
199212cisatracurium besylate 200 MG in 20 ML InjectionPSN1be30efe-4beb-411a-bf82-6e4ea68fd2621
19921220 ML cisatracurium 10 MG/ML InjectionSCD1be30efe-4beb-411a-bf82-6e4ea68fd2621
17301945 ML cisatracurium 2 MG/ML InjectionSCD1be30efe-4beb-411a-bf82-6e4ea68fd2621
199211cisatracurium 2 MG/ML Injectable SolutionSCD1be30efe-4beb-411a-bf82-6e4ea68fd2621
1730194cisatracurium (as cisatracurium besylate) 10 MG per 5 ML InjectionSY1be30efe-4beb-411a-bf82-6e4ea68fd2621
199211cisatracurium (as cisatracurium besylate) 2 MG/ML Injectable SolutionSY1be30efe-4beb-411a-bf82-6e4ea68fd2621
199212cisatracurium (as cisatracurium besylate) 200 MG per 20 ML InjectionSY1be30efe-4beb-411a-bf82-6e4ea68fd2621
199212cisatracurium 200 MG per 20 ML InjectionSY1be30efe-4beb-411a-bf82-6e4ea68fd2621

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71288-712-05712880712055 mL in 1 VIAL, SINGLE-DOSE5 mlHistorical
71288-712-067128807120610 VIAL, SINGLE-DOSE in 1 CARTON (71288-712-06) / 5 mL in 1 VIAL, SINGLE-DOSE (71288-712-05) 2019-10-310000-00-00NoNoCurrent
71288-712-95712880712955 mL in 1 VIAL, SINGLE-DOSE5 mlHistorical
71288-712-967128807129610 VIAL, SINGLE-DOSE in 1 CARTON (71288-712-96) / 5 mL in 1 VIAL, SINGLE-DOSE (71288-712-95) 2019-10-31NoNoHistorical