FDA.reportPublic FDA data

Cisatracurium besylate

Product NDC
65145-137
11-digit product format
651450137
Labeler code
65145
Product ID
65145-137_984769d6-523a-4e06-aaa7-ccbb039e38ea
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cisatracurium besylate
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Caplin Steriles Limited
Application
ANDA217725
Marketing category
ANDA
Marketing start
2025-01-17
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
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 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
65145-137-01Cisatracurium besylate1 in 1 CARTONINJECTION12
65145-137-01Cisatracurium besylate20 mL in 1 VIAL, SINGLE-DOSEINJECTION202

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65145-137-01ML - Milliliter65145-1371d79ac1f-f670-411d-95f3-55d577384e8712025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65145-137CISATRACURIUM BESYLATE INJECTION [CAPLIN STERILES LIMITED]2Current NDC, 2 package rows20250119_93101770-10a1-4bad-a762-289c793d8ace.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199211cisatracurium 2 MG/ML Injectable SolutionPSN93101770-10a1-4bad-a762-289c793d8ace2
1730194cisatracurium besylate 10 MG in 5 ML InjectionPSN93101770-10a1-4bad-a762-289c793d8ace2
199212cisatracurium besylate 200 MG in 20 ML InjectionPSN93101770-10a1-4bad-a762-289c793d8ace2
19921220 ML cisatracurium 10 MG/ML InjectionSCD93101770-10a1-4bad-a762-289c793d8ace2
17301945 ML cisatracurium 2 MG/ML InjectionSCD93101770-10a1-4bad-a762-289c793d8ace2
199211cisatracurium 2 MG/ML Injectable SolutionSCD93101770-10a1-4bad-a762-289c793d8ace2
1730194cisatracurium (as cisatracurium besylate) 10 MG per 5 ML InjectionSY93101770-10a1-4bad-a762-289c793d8ace2
199211cisatracurium (as cisatracurium besylate) 2 MG/ML Injectable SolutionSY93101770-10a1-4bad-a762-289c793d8ace2
199212cisatracurium (as cisatracurium besylate) 200 MG per 20 ML InjectionSY93101770-10a1-4bad-a762-289c793d8ace2
199212cisatracurium 200 MG per 20 ML InjectionSY93101770-10a1-4bad-a762-289c793d8ace2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
65145-137-01651450137011 VIAL, SINGLE-DOSE in 1 CARTON (65145-137-01) / 20 mL in 1 VIAL, SINGLE-DOSE2025-01-17NoNoHistorical