Brimonidine Tartrate

Product NDC
71921-185
11-digit product format
719210185
Labeler code
71921
Product ID
71921-185_81960280-6045-44e8-a499-6f737a92c7f2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Brimonidine Tartrate
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Florida Pharmaceutical Products, LLC
Application
ANDA091691
Marketing category
ANDA
Marketing start
2022-01-15
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Brimonidine Tartrate
Listing expiration
2027-12-31

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71921-185-05Brimonidine Tartrate05 mg in 1 BOTTLE, PLASTICSOLUTION/ DROPS054
71921-185-10Brimonidine Tartrate10 mg in 1 BOTTLE, PLASTICSOLUTION/ DROPS104
71921-185-15Brimonidine Tartrate15 mg in 1 BOTTLE, PLASTICSOLUTION/ DROPS154

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71921-185-05ML - Milliliter71921-1851d10cb4d-273b-4531-9465-1f4b9df0146c12022-06-06
71921-185-10ML - Milliliter71921-18553c82a56-14dd-4fac-8a16-53bf1814b78812022-06-06
71921-185-15ML - Milliliter71921-1858ff98437-b8fb-497a-b718-05746e20b1f712022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71921-185BRIMONIDINE TARTRATE SOLUTION/ DROPS [FLORIDA PHARMACEUTICAL PRODUCTS, LLC]2Current NDC, Legacy NDC, 3 package rows20220115_a25f7abf-e066-4d16-a0ba-6150bdace81d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861200brimonidine tartrate 0.2 % Ophthalmic SolutionPSNa25f7abf-e066-4d16-a0ba-6150bdace81d4
861200brimonidine tartrate 2 MG/ML Ophthalmic SolutionSCDa25f7abf-e066-4d16-a0ba-6150bdace81d4
861200brimonidine tartrate 0.2 % Ophthalmic SolutionSYa25f7abf-e066-4d16-a0ba-6150bdace81d4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71921-185-05719210185055 mg in 1 BOTTLE, PLASTIC (71921-185-05) 5 mg2022-01-150000-00-00NoNoCurrent
71921-185-107192101851010 mg in 1 BOTTLE, PLASTIC (71921-185-10) 10 mg2022-01-150000-00-00NoNoCurrent
71921-185-157192101851515 mg in 1 BOTTLE, PLASTIC (71921-185-15) 15 mg2022-01-150000-00-00NoNoCurrent