Brimonidine Tartrate

Product NDC
14445-400
11-digit product format
144450400
Labeler code
14445
Product ID
14445-400_383421a5-5d33-4f15-88f4-8b66fcbfac71
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Brimonidine Tartrate
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Indoco Remedies Limited
Application
ANDA091691
Marketing category
ANDA
Marketing start
2015-01-01
Substance
BRIMONIDINE TARTRATE
Active strength
2 mg/mg
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/mg

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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
14445-400-05Brimonidine Tartrate05 mg in 1 BOTTLE, PLASTICSOLUTION/ DROPS051
14445-400-10Brimonidine Tartrate10 mg in 1 BOTTLE, PLASTICSOLUTION/ DROPS101
14445-400-15Brimonidine Tartrate15 mg in 1 BOTTLE, PLASTICSOLUTION/ DROPS151

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
14445-400BRIMONIDINE TARTRATE SOLUTION/ DROPS [INDOCO REMEDIES LIMITED ]1Current NDC, Legacy NDC, 3 package rows20181228_383421a5-5d33-4f15-88f4-8b66fcbfac71.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861200brimonidine tartrate 0.2 % Ophthalmic SolutionPSN383421a5-5d33-4f15-88f4-8b66fcbfac711
861200brimonidine tartrate 2 MG/ML Ophthalmic SolutionSCD383421a5-5d33-4f15-88f4-8b66fcbfac711
861200brimonidine tartrate 0.2 % Ophthalmic SolutionSY383421a5-5d33-4f15-88f4-8b66fcbfac711

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
14445-400-05144450400055 mg in 1 BOTTLE, PLASTIC (14445-400-05) 5 mg2015-01-010000-00-00NoNoCurrent
14445-400-101444504001010 mg in 1 BOTTLE, PLASTIC (14445-400-10) 10 mg2015-01-010000-00-00NoNoCurrent
14445-400-151444504001515 mg in 1 BOTTLE, PLASTIC (14445-400-15) 15 mg2015-01-010000-00-00NoNoCurrent