FDA.reportPublic FDA data

Cisatracurium Besylate

Product NDC
70069-151
11-digit product format
700690151
Labeler code
70069
Product ID
70069-151_8ebb3502-ea0c-41a9-9878-f780cbe83383
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cisatracurium Besylate
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Somerset Therapeutics, LLC
Application
ANDA206791
Marketing category
ANDA
Marketing start
2019-02-04
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
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
70069-151-01Cisatracurium Besylate1 in 1 CARTONINJECTION110
70069-151-01Cisatracurium Besylate20 mL in 1 VIALINJECTION2010
70069-151-10Cisatracurium Besylate20 mL in 1 VIALINJECTION2010
70069-151-10Cisatracurium Besylate10 in 1 CARTONINJECTION1010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70069-151-01ML - Milliliter70069-151b1e93ef4-2edc-4fd7-a28d-142ba573829912019-09-05
70069-151-10ML - Milliliter70069-1515d8e2e05-f7d9-4a92-a468-b056447a74cd12019-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70069-151CISATRACURIUM BESYLATE INJECTION [SOMERSET THERAPEUTICS, LLC]9Current NDC, Legacy NDC, 4 package rows20231009_ed91f65b-e002-43bd-bfa0-5ce8b89119e6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1730194cisatracurium besylate 10 MG in 5 ML InjectionPSNed91f65b-e002-43bd-bfa0-5ce8b89119e610
199212cisatracurium besylate 200 MG in 20 ML InjectionPSNed91f65b-e002-43bd-bfa0-5ce8b89119e610
19921220 ML cisatracurium 10 MG/ML InjectionSCDed91f65b-e002-43bd-bfa0-5ce8b89119e610
17301945 ML cisatracurium 2 MG/ML InjectionSCDed91f65b-e002-43bd-bfa0-5ce8b89119e610
1730194cisatracurium (as cisatracurium besylate) 10 MG per 5 ML InjectionSYed91f65b-e002-43bd-bfa0-5ce8b89119e610
199212cisatracurium (as cisatracurium besylate) 200 MG per 20 ML InjectionSYed91f65b-e002-43bd-bfa0-5ce8b89119e610
199212cisatracurium 200 MG per 20 ML InjectionSYed91f65b-e002-43bd-bfa0-5ce8b89119e610

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70069-151-01700690151011 VIAL in 1 CARTON (70069-151-01) / 20 mL in 1 VIAL1 vial2019-02-040000-00-00NoNoCurrent
70069-151-107006901511010 VIAL in 1 CARTON (70069-151-10) / 20 mL in 1 VIAL10 vial2019-02-040000-00-00NoNoCurrent