FDA.reportPublic FDA data

Cisatracurium besylate

Product NDC
70436-112
11-digit product format
704360112
Labeler code
70436
Product ID
70436-112_20cd9789-700a-5fa0-e063-6394a90a5d0d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cisatracurium besylate
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Slate Run Pharmaceuticals, LLC
Application
ANDA216539
Marketing category
ANDA
Marketing start
2021-09-02
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
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
70436-112-82Cisatracurium besylate5 mL in 1 VIAL, SINGLE-DOSEINJECTION52
70436-112-82Cisatracurium besylate10 in 1 CARTONINJECTION102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70436-112CISATRACURIUM BESYLATE INJECTION [SLATE RUN PHARMACEUTICALS, LLC]2Current NDC, 2 package rows20240830_49185e78-d244-4426-90ef-ad109824eddb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1730194cisatracurium besylate 10 MG in 5 ML InjectionPSN49185e78-d244-4426-90ef-ad109824eddb2
199212cisatracurium besylate 200 MG in 20 ML InjectionPSN49185e78-d244-4426-90ef-ad109824eddb2
19921220 ML cisatracurium 10 MG/ML InjectionSCD49185e78-d244-4426-90ef-ad109824eddb2
17301945 ML cisatracurium 2 MG/ML InjectionSCD49185e78-d244-4426-90ef-ad109824eddb2
1730194cisatracurium (as cisatracurium besylate) 10 MG per 5 ML InjectionSY49185e78-d244-4426-90ef-ad109824eddb2
199212cisatracurium (as cisatracurium besylate) 200 MG per 20 ML InjectionSY49185e78-d244-4426-90ef-ad109824eddb2
199212cisatracurium 200 MG per 20 ML InjectionSY49185e78-d244-4426-90ef-ad109824eddb2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70436-112-827043601128210 VIAL, SINGLE-DOSE in 1 CARTON (70436-112-82) / 5 mL in 1 VIAL, SINGLE-DOSE2021-09-02NoNoHistorical