Bupivacaine Hydrochloride
Rx only
Approved
Approval ID
2dc693df-3218-4a90-b3f7-21e80966a851
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 1, 2023
Manufacturers
FDA
Huons Co., Ltd.
DUNS: 631099384
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 Code73293-0002
Application NumberANDA212822
Product Classification
M
Marketing Category
C73584
G
Generic Name
Bupivacaine hydrochloride
Product Specifications
Route of AdministrationSUBARACHNOID
Effective DateOctober 1, 2023
FDA Product Classification
INGREDIENTS (6)
DEXTROSEInactive
Quantity: 82.5 mg in 1 mL
Code: IY9XDZ35W2
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
BUPIVACAINE HYDROCHLORIDEActive
Quantity: 7.5 mg in 1 mL
Code: 7TQO7W3VT8
Classification: ACTIR
WATERInactive
Code: 059QF0KO0R
Classification: IACT
NITROGENInactive
Code: N762921K75
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT