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
NDC Product Code73293-0002
Application NumberANDA212822
Marketing CategoryC73584
Route of AdministrationSUBARACHNOID
Effective DateOctober 1, 2023
Generic NameBupivacaine hydrochloride
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