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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code82182-773
Application NumberNDA021262
Product Classification
M
Marketing Category
C73605
G
Generic Name
brimonidine tartrate
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateDecember 15, 2023
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code82182-321
Application NumberNDA021770
Product Classification
M
Marketing Category
C73605
G
Generic Name
brimonidine tartrate
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateDecember 15, 2023
FDA Product Classification
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