Bupivacaine Hydrochloride
Approved
Approval ID
d1642239-4230-b679-e053-2a95a90a3b7c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 2, 2023
Manufacturers
FDA
Medical Purchasing Solutions, LLC
DUNS: 601458529
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 Code71872-7270
Application NumberANDA207183
Product Classification
M
Marketing Category
C73584
G
Generic Name
Bupivacaine Hydrochloride
Product Specifications
Route of AdministrationPERINEURAL
Effective DateMay 2, 2023
FDA Product Classification
INGREDIENTS (6)
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
BUPIVACAINE HYDROCHLORIDEActive
Quantity: 5 mg in 1 mL
Code: 7TQO7W3VT8
Classification: ACTIR
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT