FDA.reportPublic FDA data

Brimonidine Tartrate

Product NDC
0832-1435
Requested package NDC
0832-1435-05
11-digit product format
008321435
Labeler code
0832
Product ID
0832-1435_78b3c105-f245-45c1-91b9-6481f40294a7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Brimonidine Tartrate
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Upsher-Smith Laboratories, LLC
Application
ANDA217599
Marketing category
ANDA
Marketing start
2026-09-08
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 43.

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
A217599-001BRIMONIDINE TARTRATEBRIMONIDINE TARTRATE0.1%SOLUTION/DROPS / OPHTHALMICAB2025-07-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A217599-001AB

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
2026-09-14 22:38:342026-08A217599-001BRIMONIDINE TARTRATE0.1%SOLUTION/DROPS / OPHTHALMICAB2025-07-3084e616aacf4f…
2026-08-18 06:07:402026-07A217599-001BRIMONIDINE TARTRATE0.1%SOLUTION/DROPS / OPHTHALMIC2025-07-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A217599-001BRIMONIDINE TARTRATE0.1%SOLUTION/DROPS / OPHTHALMIC2025-07-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217599-001BRIMONIDINE TARTRATE0.1%SOLUTION/DROPS / OPHTHALMICAB2025-07-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A217599-001BRIMONIDINE TARTRATE0.1%SOLUTION/DROPS / OPHTHALMICAB2025-07-306a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217599-001BRIMONIDINE TARTRATE0.1%SOLUTION/DROPS / OPHTHALMIC2025-07-30a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A217599-001AB184e616aacf4f…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217599-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A217599-001AB16a471c1ec25d…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0832-1435-05008321435051 BOTTLE, DROPPER in 1 CARTON (0832-1435-05) / 5 mL in 1 BOTTLE, DROPPER2026-09-08NoNoCurrent