Brimonidine Tartrate

Product NDC
24208-411
11-digit product format
242080411
Labeler code
24208
Product ID
24208-411_1d9d2634-f10e-8fc0-e063-6394a90a1bed
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Brimonidine Tartrate
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Bausch & Lomb Incorporated
Application
ANDA076260
Marketing category
ANDA
Marketing start
2003-05-28
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076260-001BRIMONIDINE TARTRATEBRIMONIDINE TARTRATE0.2%SOLUTION/DROPS / OPHTHALMICATRS2003-05-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A076260-001AT

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A076260-001BRIMONIDINE TARTRATE0.2%SOLUTION/DROPS / OPHTHALMICATRS2003-05-28a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A076260-001AT1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Brimonidine TartrateBRIMONIDINE TARTRATEBausch & Lomb Incorporated865f88b0-b13e-4607-a314-939f1b331e6f2024-07-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076260
application number: ANDA076260
ndc (product): 24208-411

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4S9CL2DY2HInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
861200Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
865f88b0-b13e-4607-a314-939f1b331e6fAvailable on FDA.report

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
24208-411-05Brimonidine Tartrate5 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS516
24208-411-05Brimonidine Tartrate1 in 1 CARTONSOLUTION/ DROPS116
24208-411-10Brimonidine Tartrate1 in 1 CARTONSOLUTION/ DROPS116
24208-411-10Brimonidine Tartrate10 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS1016
24208-411-15Brimonidine Tartrate1 in 1 CARTONSOLUTION/ DROPS116
24208-411-15Brimonidine Tartrate15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS1516

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24208-411-05ML - Milliliter24208-411910b93fc-97fe-47d9-bbf5-688d3233240912012-07-24
24208-411-10ML - Milliliter24208-4112dd34988-449e-43ae-ae86-537e988e816812012-07-24
24208-411-15ML - Milliliter24208-411997d8e77-e441-430b-9883-8f19bdafd2f012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BRIMONIDINE TARTRATEACTIVE INGREDIENT4S9CL2DY2HBRIMONIDINE TARTRATE SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]5
BRIMONIDINEACTIVE MOIETYE6GNX3HHTEBRIMONIDINE TARTRATE SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]5
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7BRIMONIDINE TARTRATE SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]5
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPBRIMONIDINE TARTRATE SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]5
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBBRIMONIDINE TARTRATE SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]5
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990BRIMONIDINE TARTRATE SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]5
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XBRIMONIDINE TARTRATE SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]5
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRBRIMONIDINE TARTRATE SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]5
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IBRIMONIDINE TARTRATE SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]5
WATERINACTIVE INGREDIENT059QF0KO0RBRIMONIDINE TARTRATE SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]5
BRIMONIDINE TARTRATEACTIVE INGREDIENT4S9CL2DY2HBRIMONIDINE TARTRATE (BRIMONIDINE TARTRATE) SOLUTION/ DROPS [STAT RX USA LLC]4
BRIMONIDINEACTIVE MOIETYE6GNX3HHTEBRIMONIDINE TARTRATE (BRIMONIDINE TARTRATE) SOLUTION/ DROPS [STAT RX USA LLC]4
BRIMONIDINE TARTRATEACTIVE INGREDIENT4S9CL2DY2HBRIMONIDINE TARTRATE SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]2
BRIMONIDINEACTIVE MOIETYE6GNX3HHTEBRIMONIDINE TARTRATE SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]2
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7BRIMONIDINE TARTRATE SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPBRIMONIDINE TARTRATE SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]2
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBBRIMONIDINE TARTRATE SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]2
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990BRIMONIDINE TARTRATE SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XBRIMONIDINE TARTRATE SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]2
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRBRIMONIDINE TARTRATE SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IBRIMONIDINE TARTRATE SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RBRIMONIDINE TARTRATE SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24208-411BRIMONIDINE TARTRATE SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]16Current NDC, Legacy NDC, 6 package rows20240720_865f88b0-b13e-4607-a314-939f1b331e6f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861200brimonidine tartrate 0.2 % Ophthalmic SolutionPSN865f88b0-b13e-4607-a314-939f1b331e6f16
861200brimonidine tartrate 2 MG/ML Ophthalmic SolutionSCD865f88b0-b13e-4607-a314-939f1b331e6f16
861200brimonidine tartrate 0.2 % Ophthalmic SolutionSY865f88b0-b13e-4607-a314-939f1b331e6f16
861200brimonidine tartrate 0.2 % Ophthalmic SolutionPSN4adb35fd-16e9-4606-ad94-f73378987fe46
861200brimonidine tartrate 2 MG/ML Ophthalmic SolutionSCD4adb35fd-16e9-4606-ad94-f73378987fe46
861200brimonidine tartrate 0.2 % Ophthalmic SolutionSY4adb35fd-16e9-4606-ad94-f73378987fe46
861200brimonidine tartrate 0.2 % Ophthalmic SolutionPSN5316cf97-e38e-4e78-aff2-c6972a666f3d2
861200brimonidine tartrate 2 MG/ML Ophthalmic SolutionSCD5316cf97-e38e-4e78-aff2-c6972a666f3d2
861200brimonidine tartrate 0.2 % Ophthalmic SolutionSY5316cf97-e38e-4e78-aff2-c6972a666f3d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
24208-411-05242080411051 BOTTLE, DROPPER in 1 CARTON (24208-411-05) / 5 mL in 1 BOTTLE, DROPPER2003-05-280000-00-00NoNoCurrent
24208-411-10242080411101 BOTTLE, DROPPER in 1 CARTON (24208-411-10) / 10 mL in 1 BOTTLE, DROPPER2003-05-280000-00-00NoNoCurrent
24208-411-15242080411151 BOTTLE, DROPPER in 1 CARTON (24208-411-15) / 15 mL in 1 BOTTLE, DROPPER2003-05-280000-00-00NoNoCurrent