Cisatracurium besylate

Product NDC
70436-113
11-digit product format
704360113
Labeler code
70436
Product ID
70436-113_14793b7b-0e90-7b75-e063-6394a90a9c5a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cisatracurium besylate
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Slate Run Pharmaceuticals, LLC
Application
ANDA216538
Marketing category
ANDA
Marketing start
2023-12-01
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
Rxcui199211

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
70436-113-82Cisatracurium besylate10 in 1 CARTONINJECTION102
70436-113-82Cisatracurium besylate10 mL in 1 VIAL, SINGLE-DOSEINJECTION102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70436-113CISATRACURIUM BESYLATE INJECTION [SLATE RUN PHARMACEUTICALS, LLC]2Current NDC, 2 package rows20240326_e06c4d57-bfc7-45ad-b1cd-b5b88dc43b50.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199211cisatracurium 2 MG/ML Injectable SolutionPSNe06c4d57-bfc7-45ad-b1cd-b5b88dc43b502
199211cisatracurium 2 MG/ML Injectable SolutionSCDe06c4d57-bfc7-45ad-b1cd-b5b88dc43b502
199211cisatracurium (as cisatracurium besylate) 2 MG/ML Injectable SolutionSYe06c4d57-bfc7-45ad-b1cd-b5b88dc43b502

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70436-113-827043601138210 VIAL, SINGLE-DOSE in 1 CARTON (70436-113-82) / 10 mL in 1 VIAL, SINGLE-DOSE2023-12-01NoNoHistorical