FDA.reportPublic FDA data

Cisatracurium Besylate

Product NDC
72485-513
11-digit product format
724850513
Labeler code
72485
Product ID
72485-513_b8f4c206-5f06-4692-819f-a40794db11bb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cisatracurium Besylate
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Armas Pharmaceuticals
Application
ANDA217725
Marketing category
ANDA
Marketing start
2025-01-15
Substance
CISATRACURIUM BESYLATE
Active strength
200 mg/20mL
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 BESYLATE200 mg/20mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii80YS8O1MBS
Rxcui199212

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
72485-513-01Cisatracurium Besylate20 mL in 1 VIAL, SINGLE-DOSEINJECTION201
72485-513-10Cisatracurium Besylate10 in 1 CARTONINJECTION101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72485-513-01ML - Milliliter72485-51398ff30da-96fd-4486-a277-edd50be7738212025-03-04
72485-513-10ML - Milliliter72485-513380f846a-1336-4e5a-8399-8f2823be29ec12025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72485-513CISATRACURIUM BESYLATE INJECTION [ARMAS PHARMACEUTICALS]1Current NDC, 2 package rows20250302_dd078343-1f43-4405-8048-cf6c4f456549.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199212cisatracurium besylate 200 MG in 20 ML InjectionPSNdd078343-1f43-4405-8048-cf6c4f4565491
19921220 ML cisatracurium 10 MG/ML InjectionSCDdd078343-1f43-4405-8048-cf6c4f4565491
199212cisatracurium (as cisatracurium besylate) 200 MG per 20 ML InjectionSYdd078343-1f43-4405-8048-cf6c4f4565491
199212cisatracurium 200 MG per 20 ML InjectionSYdd078343-1f43-4405-8048-cf6c4f4565491

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72485-513-017248505130120 mL in 1 VIAL, SINGLE-DOSE20 mlHistorical
72485-513-107248505131010 VIAL, SINGLE-DOSE in 1 CARTON (72485-513-10) / 20 mL in 1 VIAL, SINGLE-DOSE (72485-513-01) 2025-01-15NoNoHistorical