Atracurium Besylate

Product NDC
0409-1109
11-digit product format
004091109
Labeler code
0409
Product ID
0409-1109_926d60c7-8585-42f2-a9fc-02fcb51dc2ae
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ATRACURIUM BESYLATE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Hospira, Inc.
Application
ANDA090782
Marketing category
ANDA
Marketing start
2013-02-25
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
0409-1109-01Atracurium Besylate10 in 1 CARTONINJECTION, SOLUTION1012
0409-1109-11Atracurium Besylate5 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION512

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-1109-01ML - Milliliter0409-11096a880c6b-5057-429f-a46c-dc30abee430112013-07-02
0409-1109-11ML - Milliliter0409-1109cef72a10-fd90-4799-88d9-e0255ddaf1d912019-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ATRACURIUM BESYLATEACTIVE INGREDIENT40AX66P76PATRACURIUM BESYLATE INJECTION, SOLUTION [HOSPIRA, INC.]1
ATRACURIUMACTIVE MOIETY2GQ1IRY63PATRACURIUM BESYLATE INJECTION, SOLUTION [HOSPIRA, INC.]1
BENZENESULFONIC ACIDINACTIVE INGREDIENT685928Z18AATRACURIUM BESYLATE INJECTION, SOLUTION [HOSPIRA, INC.]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHATRACURIUM BESYLATE INJECTION, SOLUTION [HOSPIRA, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-1109ATRACURIUM BESYLATE INJECTION, SOLUTION [HOSPIRA, INC.]12Current NDC, Legacy NDC, 2 package rows20231125_de1c2dcd-295b-47ce-b7a1-a8be59939a54.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
966768atracurium besylate 10 MG/ML Injectable SolutionPSNde1c2dcd-295b-47ce-b7a1-a8be59939a5412
1718913atracurium besylate 50 MG in 5 ML InjectionPSNde1c2dcd-295b-47ce-b7a1-a8be59939a5412
17189135 ML atracurium besylate 10 MG/ML InjectionSCDde1c2dcd-295b-47ce-b7a1-a8be59939a5412
966768atracurium besylate 10 MG/ML Injectable SolutionSCDde1c2dcd-295b-47ce-b7a1-a8be59939a5412
1718913atracurium besylate 50 MG per 5 ML InjectionSYde1c2dcd-295b-47ce-b7a1-a8be59939a5412

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0409-1109-010040911090110 VIAL, SINGLE-DOSE in 1 CARTON (0409-1109-01) / 5 mL in 1 VIAL, SINGLE-DOSE (0409-1109-11) 2013-02-250000-00-00NoNoCurrent
0409-1109-11004091109115 mL in 1 VIAL, SINGLE-DOSE5 mlHistorical