Cisatracurium Besylate

Product NDC
70069-161
11-digit product format
700690161
Labeler code
70069
Product ID
70069-161_16bbec4b-027e-470e-aac9-e041bc5e24f5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cisatracurium Besylate
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Somerset Therapeutics, LLC
Application
ANDA209132
Marketing category
ANDA
Marketing start
2019-08-02
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
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 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
70069-161-01Cisatracurium Besylate10 mL in 1 VIALINJECTION1010
70069-161-01Cisatracurium Besylate1 in 1 CARTONINJECTION110
70069-161-10Cisatracurium Besylate10 mL in 1 VIAL, MULTI-DOSEINJECTION1010
70069-161-10Cisatracurium Besylate10 in 1 CARTONINJECTION1010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70069-161-01ML - Milliliter70069-161e3189165-8a69-4666-8f9d-6efe65d3af2c12019-09-05
70069-161-10ML - Milliliter70069-1612240b753-1373-4fa4-881b-0335bc4fb7bf12019-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70069-161CISATRACURIUM BESYLATE INJECTION [SOMERSET THERAPEUTICS, LLC]9Current NDC, Legacy NDC, 4 package rows20250112_23daa1f8-2a07-449d-97a6-11efdb0b9836.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199211cisatracurium 2 MG/ML Injectable SolutionPSN23daa1f8-2a07-449d-97a6-11efdb0b983610
199211cisatracurium 2 MG/ML Injectable SolutionSCD23daa1f8-2a07-449d-97a6-11efdb0b983610
199211cisatracurium (as cisatracurium besylate) 2 MG/ML Injectable SolutionSY23daa1f8-2a07-449d-97a6-11efdb0b983610

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70069-161-01700690161011 VIAL in 1 CARTON (70069-161-01) / 10 mL in 1 VIAL1 vial2019-08-020000-00-00NoNoCurrent
70069-161-107006901611010 VIAL, MULTI-DOSE in 1 CARTON (70069-161-10) / 10 mL in 1 VIAL, MULTI-DOSE2019-08-020000-00-00NoNoCurrent