FDA.reportPublic FDA data

Brimonidine Tartrate

Product NDC
68083-626
11-digit product format
680830626
Labeler code
68083
Product ID
68083-626_d45de474-a50b-4bb3-a833-3b163803a9fc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Brimonidine Tartrate
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Gland Pharma Limited
Application
ANDA219219
Marketing category
ANDA
Marketing start
2026-03-11
Substance
BRIMONIDINE TARTRATE
Active strength
1 mg/mL
Pharmacologic classes
Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A219219-001BRIMONIDINE TARTRATEBRIMONIDINE TARTRATE0.1%SOLUTION/DROPS / OPHTHALMICAB2026-03-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A219219-001AB

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
2026-08-18 06:07:402026-07A219219-001BRIMONIDINE TARTRATE0.1%SOLUTION/DROPS / OPHTHALMICAB2026-03-11caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219219-001BRIMONIDINE TARTRATE0.1%SOLUTION/DROPS / OPHTHALMICAB2026-03-11a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A219219-001AB1caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219219-001AB1a50c72e98297…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BRIMONIDINE TARTRATE1 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
861204Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e4b04ef1-6586-4386-a844-2c5fc3bd4a8fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
c6c0c444-a6ba-2fb5-a7bc-7f0443fa5791Product name420251208
8ec6541e-9842-115f-62bf-f7c9ab3aeddbProduct name320250805
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
39b7fcf4-8865-6d40-d24d-9b8c28bd6345Product name520250123
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
c93ffd9a-5bad-44d8-b5e5-16ef4d2fee72Product name120220316
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68083-626-05Brimonidine Tartrate5 mL in 1 BOTTLESOLUTION/ DROPS56
68083-626-05Brimonidine Tartrate1 in 1 CARTONSOLUTION/ DROPS16
68083-626-10Brimonidine Tartrate10 mL in 1 BOTTLESOLUTION/ DROPS106
68083-626-10Brimonidine Tartrate1 in 1 CARTONSOLUTION/ DROPS16
68083-626-15Brimonidine Tartrate15 mL in 1 BOTTLESOLUTION/ DROPS156
68083-626-15Brimonidine Tartrate1 in 1 CARTONSOLUTION/ DROPS16

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

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

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Brimonidine TartrateBRIMONIDINE TARTRATEGland Pharma Limitede4b04ef1-6586-4386-a844-2c5fc3bd4a8f2026-03-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 219219
application number: ANDA219219
ndc (product): 68083-626

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861204brimonidine tartrate 0.1 % Ophthalmic SolutionPSNe4b04ef1-6586-4386-a844-2c5fc3bd4a8f6
861204brimonidine tartrate 1 MG/ML Ophthalmic SolutionSCDe4b04ef1-6586-4386-a844-2c5fc3bd4a8f6
861204brimonidine tartrate 0.1 % Ophthalmic SolutionSYe4b04ef1-6586-4386-a844-2c5fc3bd4a8f6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68083-626-05680830626051 BOTTLE in 1 CARTON (68083-626-05) / 5 mL in 1 BOTTLE1 bottle2026-03-11NoNoCurrent
68083-626-10680830626101 BOTTLE in 1 CARTON (68083-626-10) / 10 mL in 1 BOTTLE1 bottle2026-03-11NoNoCurrent
68083-626-15680830626151 BOTTLE in 1 CARTON (68083-626-15) / 15 mL in 1 BOTTLE1 bottle2026-03-11NoNoCurrent