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Atracurium Besylate

Approved
Approval ID

f7b6a720-05a7-4d6a-9200-21bdc90fc1c4

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Feb 14, 2022

Manufacturers
FDA

AuroMedics Pharma LLC

DUNS: 968961354

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Atracurium Besylate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code55150-217
Application NumberANDA206011
Product Classification
M
Marketing Category
C73584
G
Generic Name
Atracurium Besylate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateFebruary 14, 2022
FDA Product Classification

INGREDIENTS (4)

ATRACURIUM BESYLATEActive
Quantity: 100 mg in 10 mL
Code: 40AX66P76P
Classification: ACTIB
BENZENESULFONIC ACIDInactive
Code: 685928Z18A
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

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Atracurium Besylate - FDA Drug Approval Details