Brimonidine Tartrate

Product NDC
61314-143
11-digit product format
613140143
Labeler code
61314
Product ID
61314-143_d30b64a2-52a4-4c29-bb4e-64cd0444127b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Brimonidine Tartrate
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
Sandoz Inc
Application
ANDA076254
Marketing category
ANDA
Marketing start
2003-09-17
Substance
BRIMONIDINE TARTRATE
Active strength
2 mg/mL
Pharmacologic classes
Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Brimonidine Tartrate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BRIMONIDINE TARTRATE2 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4S9CL2DY2H
Rxcui861200

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6c0c444-a6ba-2fb5-a7bc-7f0443fa5791Product name420251208
8ec6541e-9842-115f-62bf-f7c9ab3aeddbProduct name320250805
39b7fcf4-8865-6d40-d24d-9b8c28bd6345Product name520250123
c93ffd9a-5bad-44d8-b5e5-16ef4d2fee72Product name120220316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61314-143-05Brimonidine Tartrate5 mL in 1 BOTTLESOLUTION57
61314-143-05Brimonidine Tartrate1 in 1 CARTONSOLUTION17
61314-143-10Brimonidine Tartrate1 in 1 CARTONSOLUTION17
61314-143-10Brimonidine Tartrate10 mL in 1 BOTTLESOLUTION107
61314-143-15Brimonidine Tartrate1 in 1 CARTONSOLUTION17
61314-143-15Brimonidine Tartrate15 mL in 1 BOTTLESOLUTION157

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61314-143-05ML - Milliliter61314-143f6bdc16d-7ae2-4d57-b76f-647992fb028d12012-07-24
61314-143-10ML - Milliliter61314-1433ee7b551-f220-4043-a5dd-fd3ab52ccb8b12012-07-24
61314-143-15ML - Milliliter61314-14315375be0-8add-4498-99b7-920b19ac724112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BRIMONIDINE TARTRATEACTIVE INGREDIENT4S9CL2DY2HBRIMONIDINE TARTRATE SOLUTION [SANDOZ INC]2
BRIMONIDINEACTIVE MOIETYE6GNX3HHTEBRIMONIDINE TARTRATE SOLUTION [SANDOZ INC]2
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7BRIMONIDINE TARTRATE SOLUTION [SANDOZ INC]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPBRIMONIDINE TARTRATE SOLUTION [SANDOZ INC]2
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBBRIMONIDINE TARTRATE SOLUTION [SANDOZ INC]2
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990BRIMONIDINE TARTRATE SOLUTION [SANDOZ INC]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XBRIMONIDINE TARTRATE SOLUTION [SANDOZ INC]2
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRBRIMONIDINE TARTRATE SOLUTION [SANDOZ INC]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IBRIMONIDINE TARTRATE SOLUTION [SANDOZ INC]2
WATERINACTIVE INGREDIENT059QF0KO0RBRIMONIDINE TARTRATE SOLUTION [SANDOZ INC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61314-143BRIMONIDINE TARTRATE SOLUTION [SANDOZ INC]6Current NDC, Legacy NDC, 6 package rows20220217_dfd85672-fa4b-40e3-ac9c-81b8d9e4ffde.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861200brimonidine tartrate 0.2 % Ophthalmic SolutionPSNdfd85672-fa4b-40e3-ac9c-81b8d9e4ffde7
861200brimonidine tartrate 2 MG/ML Ophthalmic SolutionSCDdfd85672-fa4b-40e3-ac9c-81b8d9e4ffde7
861200brimonidine tartrate 0.2 % Ophthalmic SolutionSYdfd85672-fa4b-40e3-ac9c-81b8d9e4ffde7
861200brimonidine tartrate 0.2 % Ophthalmic SolutionPSN7f70f916-b4f9-4552-a002-375df20712cc6
861200brimonidine tartrate 2 MG/ML Ophthalmic SolutionSCD7f70f916-b4f9-4552-a002-375df20712cc6
861200brimonidine tartrate 0.2 % Ophthalmic SolutionSY7f70f916-b4f9-4552-a002-375df20712cc6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61314-143-05613140143051 BOTTLE in 1 CARTON (61314-143-05) / 5 mL in 1 BOTTLE1 bottle2003-09-170000-00-00NoNoCurrent
61314-143-10613140143101 BOTTLE in 1 CARTON (61314-143-10) / 10 mL in 1 BOTTLE1 bottle2003-09-170000-00-00NoNoCurrent
61314-143-15613140143151 BOTTLE in 1 CARTON (61314-143-15) / 15 mL in 1 BOTTLE1 bottle2003-09-170000-00-00NoNoCurrent