Atracurium Besylate

Product NDC
55150-216
11-digit product format
551500216
Labeler code
55150
Product ID
55150-216_379b43a8-f4ba-4a29-a478-23dbb33fbefa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atracurium Besylate
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
AuroMedics Pharma LLC
Application
ANDA206010
Marketing category
ANDA
Marketing start
2015-04-08
Substance
ATRACURIUM BESYLATE
Active strength
50 mg/5mL
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 BESYLATE50 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii40AX66P76P
Rxcui1718913

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
55150-216-05Atracurium Besylate10 in 1 CARTONINJECTION, SOLUTION105
55150-216-05Atracurium Besylate5 mL in 1 VIAL, SINGLE-USEINJECTION, SOLUTION55

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55150-216-05ML - Milliliter55150-216463b0352-70ba-4085-9a0c-d5c96033dae312015-08-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ATRACURIUM BESYLATEACTIVE INGREDIENT40AX66P76PATRACURIUM BESYLATE INJECTION, SOLUTION [AUROMEDICS PHARMA LLC]1
ATRACURIUMACTIVE MOIETY2GQ1IRY63PATRACURIUM BESYLATE INJECTION, SOLUTION [AUROMEDICS PHARMA LLC]1
BENZENESULFONIC ACIDINACTIVE INGREDIENT685928Z18AATRACURIUM BESYLATE INJECTION, SOLUTION [AUROMEDICS PHARMA LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RATRACURIUM BESYLATE INJECTION, SOLUTION [AUROMEDICS PHARMA LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55150-216ATRACURIUM BESYLATE INJECTION, SOLUTION [AUROMEDICS PHARMA LLC]5Current NDC, Legacy NDC, 2 package rows20220531_71d4bc78-57df-474b-8b19-811a959f1fce.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1718913atracurium besylate 50 MG in 5 ML InjectionPSN71d4bc78-57df-474b-8b19-811a959f1fce5
17189135 ML atracurium besylate 10 MG/ML InjectionSCD71d4bc78-57df-474b-8b19-811a959f1fce5
1718913atracurium besylate 50 MG per 5 ML InjectionSY71d4bc78-57df-474b-8b19-811a959f1fce5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55150-216-055515002160510 VIAL, SINGLE-USE in 1 CARTON (55150-216-05) / 5 mL in 1 VIAL, SINGLE-USE2015-04-080000-00-00NoNoCurrent