FDA.reportPublic FDA data

Cisatracurium Besylate

Product NDC
0409-1103
11-digit product format
004091103
Labeler code
0409
Product ID
0409-1103_7b64e51a-1a55-4949-ac7c-b0a21cbd6ec9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CISATRACURIUM BESYLATE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Hospira, Inc.
Application
ANDA203236
Marketing category
ANDA
Marketing start
2019-12-02
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
Rxcui199211, 199212, 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
0409-1103-01Cisatracurium Besylate10 in 1 CARTONINJECTION, SOLUTION1015
0409-1103-11Cisatracurium Besylate20 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION2015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-1103-01ML - Milliliter0409-11038b03af03-114e-4a2c-b5c6-8d420a008bfb12019-12-10
0409-1103-11ML - Milliliter0409-110315e0c58d-1586-4a03-a965-67200d04446712019-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-1103CISATRACURIUM BESYLATE INJECTION, SOLUTION [HOSPIRA, INC.]14Current NDC, Legacy NDC, 2 package rows20240412_67908e20-044d-454d-9c51-bf106e817bd0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199211cisatracurium 2 MG/ML Injectable SolutionPSN67908e20-044d-454d-9c51-bf106e817bd015
1730194cisatracurium besylate 10 MG in 5 ML InjectionPSN67908e20-044d-454d-9c51-bf106e817bd015
199212cisatracurium besylate 200 MG in 20 ML InjectionPSN67908e20-044d-454d-9c51-bf106e817bd015
19921220 ML cisatracurium 10 MG/ML InjectionSCD67908e20-044d-454d-9c51-bf106e817bd015
17301945 ML cisatracurium 2 MG/ML InjectionSCD67908e20-044d-454d-9c51-bf106e817bd015
199211cisatracurium 2 MG/ML Injectable SolutionSCD67908e20-044d-454d-9c51-bf106e817bd015
1730194cisatracurium (as cisatracurium besylate) 10 MG per 5 ML InjectionSY67908e20-044d-454d-9c51-bf106e817bd015
199211cisatracurium (as cisatracurium besylate) 2 MG/ML Injectable SolutionSY67908e20-044d-454d-9c51-bf106e817bd015
199212cisatracurium (as cisatracurium besylate) 200 MG per 20 ML InjectionSY67908e20-044d-454d-9c51-bf106e817bd015
199212cisatracurium 200 MG per 20 ML InjectionSY67908e20-044d-454d-9c51-bf106e817bd015

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0409-1103-010040911030110 VIAL, SINGLE-DOSE in 1 CARTON (0409-1103-01) / 20 mL in 1 VIAL, SINGLE-DOSE (0409-1103-11) 2019-12-020000-00-00NoNoCurrent
0409-1103-110040911031120 mL in 1 VIAL, SINGLE-DOSE20 mlHistorical