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Sensorcaine

Sensorcaine 0.25% (Bupivacaine HCl) 50mL

Approved
Approval ID

e5808712-4487-43b2-891f-e1ef47a9e28d

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 29, 2022

Manufacturers
FDA

General Injectables & Vaccines, Inc

DUNS: 108250663

Products 1

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

Bupivacaine Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code52584-465
Application NumberNDA018304
Product Classification
M
Marketing Category
C73594
G
Generic Name
Bupivacaine Hydrochloride
Product Specifications
Route of AdministrationINFILTRATION, PERINEURAL
Effective DateDecember 29, 2022
FDA Product Classification

INGREDIENTS (1)

Bupivacaine HydrochlorideActive
Quantity: 2.5 mg in 1 mL
Code: 7TQO7W3VT8
Classification: ACTIR

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Sensorcaine - FDA Drug Approval Details