FDA.reportPublic FDA data

Atracurium Besylate

Product NDC
71288-701
11-digit product format
712880701
Labeler code
71288
Product ID
71288-701_2e0da959-ece2-4643-9b93-a1ce7d59efdd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atracurium Besylate
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Meitheal Pharmaceuticals Inc.
Application
ANDA091488
Marketing category
ANDA
Marketing start
2018-05-15
Substance
ATRACURIUM 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
Atracurium Besylate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ATRACURIUM BESYLATE10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii40AX66P76P
Rxcui966768, 1718913

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ee531c6f-519c-e9d0-f89e-d306203b9c49Product name420170804

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71288-701-05Atracurium Besylate10 in 1 CARTONINJECTION, SOLUTION105
71288-701-06Atracurium Besylate5 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION55

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71288-701-05ML - Milliliter71288-701a121c299-44b7-4c2d-aba9-7803b3c1013612018-07-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71288-701ATRACURIUM BESYLATE INJECTION, SOLUTION [MEITHEAL PHARMACEUTICALS INC.]5Current NDC, Legacy NDC, 2 package rows20241206_efe90ee2-fe9e-421f-9e54-2961085d3b12.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
966768atracurium besylate 10 MG/ML Injectable SolutionPSNefe90ee2-fe9e-421f-9e54-2961085d3b125
1718913atracurium besylate 50 MG in 5 ML InjectionPSNefe90ee2-fe9e-421f-9e54-2961085d3b125
17189135 ML atracurium besylate 10 MG/ML InjectionSCDefe90ee2-fe9e-421f-9e54-2961085d3b125
966768atracurium besylate 10 MG/ML Injectable SolutionSCDefe90ee2-fe9e-421f-9e54-2961085d3b125
1718913atracurium besylate 50 MG per 5 ML InjectionSYefe90ee2-fe9e-421f-9e54-2961085d3b125

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71288-701-057128807010510 VIAL, SINGLE-DOSE in 1 CARTON (71288-701-05) / 5 mL in 1 VIAL, SINGLE-DOSE (71288-701-06) 2018-05-150000-00-00NoNoCurrent
71288-701-06712880701065 mL in 1 VIAL, SINGLE-DOSE5 mlHistorical