Carteolol Hydrochloride
Carteolol Hydrochloride Ophthalmic Solution USP, 1% Rx OnlySterile
Approved
Approval ID
571fe550-399d-4296-835c-37aa1ab9b409
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 31, 2021
Manufacturers
FDA
Sandoz Inc
DUNS: 005387188
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Carteolol Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code61314-238
Application NumberANDA075476
Product Classification
M
Marketing Category
C73584
G
Generic Name
Carteolol Hydrochloride
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateMarch 7, 2012
FDA Product Classification
INGREDIENTS (8)
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORMInactive
Code: GR686LBA74
Classification: IACT
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMInactive
Code: 3980JIH2SW
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
CARTEOLOL HYDROCHLORIDEActive
Quantity: 10 mg in 1 mL
Code: 4797W6I0T4
Classification: ACTIB