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
NDC Product Code64980-513
Application NumberANDA077259
Marketing CategoryC73584
Route of AdministrationOPHTHALMIC
Effective DateOctober 25, 2023
Generic Nametimolol maleate
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
NDC Product Code64980-514
Application NumberANDA077259
Marketing CategoryC73584
Route of AdministrationOPHTHALMIC
Effective DateOctober 25, 2023
Generic Nametimolol maleate
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