FDA.reportPublic FDA data

Atracurium Besylate

Product NDC
0409-1105
11-digit product format
004091105
Labeler code
0409
Product ID
0409-1105_926d60c7-8585-42f2-a9fc-02fcb51dc2ae
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ATRACURIUM BESYLATE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Hospira, Inc.
Application
ANDA090761
Marketing category
ANDA
Marketing start
2013-05-29
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
0409-1105-02Atracurium Besylate10 in 1 CARTONINJECTION, SOLUTION1012
0409-1105-22Atracurium Besylate10 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION1012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-1105-02ML - Milliliter0409-1105847509b0-a5ea-49c8-81d7-46083755fdce12013-07-02
0409-1105-22ML - Milliliter0409-110588bb696b-d3e8-4565-a2f5-088efca2cd7c12019-07-02

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
0409-1105ATRACURIUM 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
0409-1105-020040911050210 VIAL, MULTI-DOSE in 1 CARTON (0409-1105-02) / 10 mL in 1 VIAL, MULTI-DOSE (0409-1105-22) 2013-05-290000-00-00NoNoCurrent
0409-1105-220040911052210 mL in 1 VIAL, MULTI-DOSE10 mlHistorical