Brimonidine tartrate
These highlights do not include all the information needed to use Brimonidine tartrate ophthalmic solution 0.1% and 0.15% safely and effectively. See full prescribing information for brimonidine tartrate ophthalmic solution 0.1% and 0.15%. Brimonidine tartrate ophthalmic solution 0.1% and 0.15% Initial U.S. Approval: 1996
Approved
Approval ID
5c4aea88-95ca-4da8-a3da-02f10c8b6623
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 21, 2023
Manufacturers
FDA
Pacific Pharma, Inc.
DUNS: 877645267
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
brimonidine tartrate
PRODUCT DETAILS
NDC Product Code82182-773
Application NumberNDA021262
Marketing CategoryC73605
Route of AdministrationOPHTHALMIC
Effective DateDecember 15, 2023
Generic Namebrimonidine tartrate
INGREDIENTS (12)
BRIMONIDINE TARTRATEActive
Quantity: 1.5 mg in 1 mL
Code: 4S9CL2DY2H
Classification: ACTIB
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDInactive
Code: K679OBS311
Classification: IACT
SODIUM BORATEInactive
Code: 91MBZ8H3QO
Classification: IACT
BORIC ACIDInactive
Code: R57ZHV85D4
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
POTASSIUM CHLORIDEInactive
Code: 660YQ98I10
Classification: IACT
CALCIUM CHLORIDEInactive
Code: M4I0D6VV5M
Classification: IACT
MAGNESIUM CHLORIDEInactive
Code: 02F3473H9O
Classification: IACT
SODIUM CHLORITEInactive
Code: G538EBV4VF
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
brimonidine tartrate
PRODUCT DETAILS
NDC Product Code82182-321
Application NumberNDA021770
Marketing CategoryC73605
Route of AdministrationOPHTHALMIC
Effective DateDecember 15, 2023
Generic Namebrimonidine tartrate
INGREDIENTS (12)
SODIUM BORATEInactive
Code: 91MBZ8H3QO
Classification: IACT
BORIC ACIDInactive
Code: R57ZHV85D4
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMInactive
Code: K679OBS311
Classification: IACT
BRIMONIDINE TARTRATEActive
Quantity: 1 mg in 1 mL
Code: 4S9CL2DY2H
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
POTASSIUM CHLORIDEInactive
Code: 660YQ98I10
Classification: IACT
SODIUM CHLORITEInactive
Code: G538EBV4VF
Classification: IACT
CALCIUM CHLORIDEInactive
Code: M4I0D6VV5M
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
MAGNESIUM CHLORIDEInactive
Code: 02F3473H9O
Classification: IACT