Levobunolol Hydrochloride
(Sterile)
Approved
Approval ID
5ab1efbe-530b-4787-b40a-c7dbf18161e1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 31, 2022
Manufacturers
FDA
Bausch & Lomb Incorporated
DUNS: 002207751
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Levobunolol Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code24208-505
Application NumberANDA074326
Product Classification
M
Marketing Category
C73584
G
Generic Name
Levobunolol Hydrochloride
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateOctober 31, 2022
FDA Product Classification
INGREDIENTS (11)
BENZALKONIUM CHLORIDEInactive
Quantity: 0.04 mg in 1 mL
Code: F5UM2KM3W7
Classification: IACT
LEVOBUNOLOL HYDROCHLORIDEActive
Quantity: 5 mg in 1 mL
Code: O90S49LDHH
Classification: ACTIB
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Quantity: 14 mg in 1 mL
Code: 532B59J990
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
SODIUM METABISULFITEInactive
Code: 4VON5FNS3C
Classification: IACT
MONOBASIC POTASSIUM PHOSPHATEInactive
Code: 4J9FJ0HL51
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORMInactive
Code: GR686LBA74
Classification: CNTM