cisatracurium besylate

Product NDC
72785-0008
11-digit product format
727850008
Labeler code
72785
Product ID
72785-0008_1b257332-a1a5-406e-86e4-283580657dc6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cisatracurium besylate
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Zydus Lifesciences Limited
Application
ANDA212171
Marketing category
ANDA
Marketing start
2020-02-12
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
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
72785-0008-1cisatracurium besylate5 mL in 1 VIALINJECTION53
72785-0008-6cisatracurium besylate10 in 1 CARTONINJECTION103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72785-0008CISATRACURIUM BESYLATE INJECTION [ZYDUS LIFESCIENCES LIMITED]3Current NDC, Legacy NDC, 2 package rows20221108_e145a40e-b046-4064-b35e-0da40ff3703e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1730194cisatracurium besylate 10 MG in 5 ML InjectionPSNe145a40e-b046-4064-b35e-0da40ff3703e3
199212cisatracurium besylate 200 MG in 20 ML InjectionPSNe145a40e-b046-4064-b35e-0da40ff3703e3
19921220 ML cisatracurium 10 MG/ML InjectionSCDe145a40e-b046-4064-b35e-0da40ff3703e3
17301945 ML cisatracurium 2 MG/ML InjectionSCDe145a40e-b046-4064-b35e-0da40ff3703e3
1730194cisatracurium (as cisatracurium besylate) 10 MG per 5 ML InjectionSYe145a40e-b046-4064-b35e-0da40ff3703e3
199212cisatracurium (as cisatracurium besylate) 200 MG per 20 ML InjectionSYe145a40e-b046-4064-b35e-0da40ff3703e3
199212cisatracurium 200 MG per 20 ML InjectionSYe145a40e-b046-4064-b35e-0da40ff3703e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72785-0008-1727850008015 mL in 1 VIAL5 mlHistorical
72785-0008-67278500080610 VIAL in 1 CARTON (72785-0008-6) / 5 mL in 1 VIAL (72785-0008-1) 10 vial2020-02-120000-00-00NoNoCurrent