TIMOLOL MALEATE
Timolol Maleate Ophthalmic Solution, USP 0.25% and 0.5%
Approved
Approval ID
2ed21930-1e05-46de-8acd-cb6f4798a7fa
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 25, 2023
Manufacturers
FDA
Rising Pharma Holdings, Inc.
DUNS: 116880195
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
timolol maleate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64980-513
Application NumberANDA077259
Product Classification
M
Marketing Category
C73584
G
Generic Name
timolol maleate
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateOctober 25, 2023
FDA Product Classification
INGREDIENTS (7)
TIMOLOL MALEATEActive
Quantity: 2.5 mg in 1 mL
Code: P8Y54F701R
Classification: ACTIM
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SODIUM PHOSPHATE, DIBASICInactive
Code: GR686LBA74
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
BENZALKONIUM CHLORIDEInactive
Quantity: 0.1 mg in 1 mL
Code: F5UM2KM3W7
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM PHOSPHATE, MONOBASICInactive
Code: 3980JIH2SW
Classification: IACT
timolol maleate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64980-514
Application NumberANDA077259
Product Classification
M
Marketing Category
C73584
G
Generic Name
timolol maleate
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateOctober 25, 2023
FDA Product Classification
INGREDIENTS (7)
TIMOLOL MALEATEActive
Quantity: 5 mg in 1 mL
Code: P8Y54F701R
Classification: ACTIM
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATEInactive
Code: 5QWK665956
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, DODECAHYDRATEInactive
Code: E1W4N241FO
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
BENZALKONIUM CHLORIDEInactive
Quantity: 0.1 mg in 1 mL
Code: F5UM2KM3W7
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT