Home NDC 63629-9616 BRIMONIDINE
Product NDC 63629-9616
11-digit product format 636299616
Labeler code 63629
Product ID 63629-9616_ee63f0f9-fb9a-4151-9e1b-3e8f2e8c2ee4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name brimonidine
Dosage form GEL
Route TOPICAL
Labeler Bryant Ranch Prepack
Application ANDA209158
Marketing category ANDA
Marketing start 2023-01-01
Substance BRIMONIDINE TARTRATE
Active strength 5 mg/g
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 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A209158-001 BRIMONIDINE TARTRATE BRIMONIDINE TARTRATE EQ 0.33% BASE GEL / TOPICAL AB 2021-09-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A209158-001 AB
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A209158-001 BRIMONIDINE TARTRATE EQ 0.33% BASE GEL / TOPICAL AB 2021-09-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A209158-001 BRIMONIDINE TARTRATE EQ 0.33% BASE GEL / TOPICAL AB 2021-09-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209158-001 BRIMONIDINE TARTRATE EQ 0.33% BASE GEL / TOPICAL AB 2021-09-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209158-001 BRIMONIDINE TARTRATE EQ 0.33% BASE GEL / TOPICAL AB 2021-09-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209158-001 BRIMONIDINE TARTRATE EQ 0.33% BASE GEL / TOPICAL AB 2021-09-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209158-001 BRIMONIDINE TARTRATE EQ 0.33% BASE GEL / TOPICAL AB 2021-09-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209158-001 BRIMONIDINE TARTRATE EQ 0.33% BASE GEL / TOPICAL AB 2021-09-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209158-001 BRIMONIDINE TARTRATE EQ 0.33% BASE GEL / TOPICAL AB 2021-09-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209158-001 BRIMONIDINE TARTRATE EQ 0.33% BASE GEL / TOPICAL AB 2021-09-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209158-001 BRIMONIDINE TARTRATE EQ 0.33% BASE GEL / TOPICAL AB 2021-09-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209158-001 BRIMONIDINE TARTRATE EQ 0.33% BASE GEL / TOPICAL AB 2021-09-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209158-001 BRIMONIDINE TARTRATE EQ 0.33% BASE GEL / TOPICAL AB 2021-09-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209158-001 BRIMONIDINE TARTRATE EQ 0.33% BASE GEL / TOPICAL AB 2021-09-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209158-001 BRIMONIDINE TARTRATE EQ 0.33% BASE GEL / TOPICAL AB 2021-09-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A209158-001 BRIMONIDINE TARTRATE EQ 0.33% BASE GEL / TOPICAL AB 2021-09-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209158-001 BRIMONIDINE TARTRATE EQ 0.33% BASE GEL / TOPICAL 2021-09-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A209158-001 BRIMONIDINE TARTRATE EQ 0.33% BASE GEL / TOPICAL AB 2021-09-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A209158-001 BRIMONIDINE TARTRATE EQ 0.33% BASE GEL / TOPICAL AB 2021-09-23 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A209158-001 BRIMONIDINE TARTRATE EQ 0.33% BASE GEL / TOPICAL AB 2021-09-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A209158-001 BRIMONIDINE TARTRATE EQ 0.33% BASE GEL / TOPICAL AB 2021-09-23 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A209158-001 BRIMONIDINE TARTRATE EQ 0.33% BASE GEL / TOPICAL AB 2021-09-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A209158-001 BRIMONIDINE TARTRATE EQ 0.33% BASE GEL / TOPICAL AB 2021-09-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A209158-001 BRIMONIDINE TARTRATE EQ 0.33% BASE GEL / TOPICAL AB 2021-09-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A209158-001 BRIMONIDINE TARTRATE EQ 0.33% BASE GEL / TOPICAL AB 2021-09-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A209158-001 BRIMONIDINE TARTRATE EQ 0.33% BASE GEL / TOPICAL AB 2021-09-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A209158-001 BRIMONIDINE TARTRATE EQ 0.33% BASE GEL / TOPICAL AB 2021-09-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A209158-001 BRIMONIDINE TARTRATE EQ 0.33% BASE GEL / TOPICAL AB 2021-09-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A209158-001 BRIMONIDINE TARTRATE EQ 0.33% BASE GEL / TOPICAL AB 2021-09-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A209158-001 BRIMONIDINE TARTRATE EQ 0.33% BASE GEL / TOPICAL AB 2021-09-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A209158-001 BRIMONIDINE TARTRATE EQ 0.33% BASE GEL / TOPICAL 2021-09-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A209158-001 BRIMONIDINE TARTRATE EQ 0.33% BASE GEL / TOPICAL 2021-09-23 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A209158-001 BRIMONIDINE TARTRATE EQ 0.33% BASE GEL / TOPICAL 2021-09-23 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A209158-001 BRIMONIDINE TARTRATE EQ 0.33% BASE GEL / TOPICAL 2021-09-23 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A209158-001 BRIMONIDINE TARTRATE EQ 0.33% BASE GEL / TOPICAL AB 2021-09-23 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base BRIMONIDINE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BRIMONIDINE TARTRATE 5 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4S9CL2DY2H Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1437707 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63629-9616-1 BRIMONIDINE 30 g in 1 BOTTLE, PUMP GEL 30 100 63629-9616-1 BRIMONIDINE 1 in 1 CARTON GEL 1 100
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63629-9616 BRIMONIDINE GEL [BRYANT RANCH PREPACK] 100 Current NDC, 2 package rows 20230204_9f17bf0c-d880-4328-bf92-00ac81d02fd1.zip
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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 63629-9616-1 63629961601 1 BOTTLE, PUMP in 1 CARTON (63629-9616-1) / 30 g in 1 BOTTLE, PUMP 2023-02-03 No No Current