Home NDC 61314-144 Brimonidine Tartrate
Product NDC 61314-144
11-digit product format 613140144
Labeler code 61314
Product ID 61314-144_6a98ed35-7065-4099-aefc-6d22e674ef55
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Brimonidine Tartrate
Dosage form SOLUTION
Route OPHTHALMIC
Labeler Sandoz Inc
Application NDA021764
Marketing category NDA
Marketing start 2010-10-02
Substance BRIMONIDINE TARTRATE
Active strength 1.5 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 43 .
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 N021764-001 QOLIANA BRIMONIDINE TARTRATE 0.15% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2006-05-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N021764-001 AT
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.
Product history page 1 of 2 · 43 observed 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 2026-09-14 22:38:34 2026-08 N021764-001 QOLIANA 0.15% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2006-05-22 84e616aacf4f…2026-08-18 06:07:40 2026-07 N021764-001 QOLIANA 0.15% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2006-05-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021764-001 QOLIANA 0.15% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2006-05-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021764-001 QOLIANA 0.15% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2006-05-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021764-001 QOLIANA 0.15% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2006-05-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021764-001 QOLIANA 0.15% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2006-05-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021764-001 QOLIANA 0.15% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2006-05-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021764-001 QOLIANA 0.15% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2006-05-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021764-001 QOLIANA 0.15% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2006-05-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021764-001 QOLIANA 0.15% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2006-05-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021764-001 QOLIANA 0.15% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2006-05-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021764-001 QOLIANA 0.15% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2006-05-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021764-001 QOLIANA 0.15% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2006-05-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021764-001 QOLIANA 0.15% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2006-05-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021764-001 QOLIANA 0.15% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2006-05-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021764-001 QOLIANA 0.15% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2006-05-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021764-001 QOLIANA 0.15% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2006-05-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021764-001 QOLIANA 0.15% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2006-05-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021764-001 QOLIANA 0.15% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2006-05-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021764-001 QOLIANA 0.15% SOLUTION/DROPS / OPHTHALMIC AT 2006-05-22 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021764-001 QOLIANA 0.15% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2006-05-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021764-001 QOLIANA 0.15% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2006-05-22 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021764-001 QOLIANA 0.15% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2006-05-22 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021764-001 QOLIANA 0.15% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2006-05-22 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021764-001 QOLIANA 0.15% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2006-05-22 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021764-001 QOLIANA 0.15% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2006-05-22 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021764-001 QOLIANA 0.15% SOLUTION/DROPS / OPHTHALMIC AT 2006-05-22 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021764-001 QOLIANA 0.15% SOLUTION/DROPS / OPHTHALMIC AT 2006-05-22 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021764-001 QOLIANA 0.15% SOLUTION/DROPS / OPHTHALMIC AT 2006-05-22 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021764-001 QOLIANA 0.15% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2006-05-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021764-001 QOLIANA 0.15% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2006-05-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021764-001 QOLIANA 0.15% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2006-05-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021764-001 QOLIANA 0.15% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2006-05-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021764-001 QOLIANA 0.15% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2006-05-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021764-001 QOLIANA 0.15% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2006-05-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021764-001 QOLIANA 0.15% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2006-05-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021764-001 QOLIANA 0.15% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2006-05-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021764-001 QOLIANA 0.15% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2006-05-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021764-001 QOLIANA 0.15% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2006-05-22 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021764-001 QOLIANA 0.15% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2006-05-22 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021764-001 7265117 2025-08-19 Drug product 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021764-001 7265117 2025-08-19 Drug product 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021764-001 7265117 2025-08-19 Drug product fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021764-001 7265117 2025-08-19 Drug product b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021764-001 7265117 2025-08-19 Drug product 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021764-001 7265117 2025-08-19 Drug product 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021764-001 7265117 2025-08-19 Drug product 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021764-001 7265117 2025-08-19 Drug product d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021764-001 7265117 2025-08-19 Drug product d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021764-001 7265117 2025-08-19 Drug product 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021764-001 7265117 2025-08-19 Drug product 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021764-001 7265117 2025-08-19 Drug product 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021764-001 7265117 2025-08-19 Drug product 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021764-001 7265117 2025-08-19 Drug product 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021764-001 7265117 2025-08-19 Drug product 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021764-001 7265117 2025-08-19 Drug product 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021764-001 7265117 2025-08-19 Drug product 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021764-001 7265117 2025-08-19 Drug product bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021764-001 7265117 2025-08-19 Drug product 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021764-001 7265117 2025-08-19 Drug product 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021764-001 7265117 2025-08-19 Drug product 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021764-001 7265117 2025-08-19 Drug product 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021764-001 7265117 2025-08-19 Drug product c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021764-001 7265117 2025-08-19 Drug product 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021764-001 7265117 2025-08-19 Drug product b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021764-001 7265117 2025-08-19 Drug product ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021764-001 7265117 2025-08-19 Drug product 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021764-001 7265117 2025-08-19 Drug product 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021764-001 7265117 2025-08-19 Drug product ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021764-001 7265117 2025-08-19 Drug product a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021764-001 7265117 2025-08-19 Drug product 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021764-001 7265117 2025-08-19 Drug product a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021764-001 7265117 2025-08-19 Drug product 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021764-001 7265117 2025-08-19 Drug product 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021764-001 7265117 2025-08-19 Drug product 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021764-001 7265117 2025-08-19 Drug product 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021764-001 7265117 2025-08-19 Drug product f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021764-001 7265117 2025-08-19 Drug product e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021764-001 7265117 2025-08-19 Drug product cb3db0bc1861…
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 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BRIMONIDINE TARTRATE 1.5 mg/mL
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 861208 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 61314-144-05 Brimonidine Tartrate 1 in 1 CARTON SOLUTION 1 11 61314-144-05 Brimonidine Tartrate 5 mL in 1 BOTTLE SOLUTION 5 11 61314-144-10 Brimonidine Tartrate 1 in 1 CARTON SOLUTION 1 11 61314-144-10 Brimonidine Tartrate 10 mL in 1 BOTTLE SOLUTION 10 11 61314-144-15 Brimonidine Tartrate 15 mL in 1 BOTTLE SOLUTION 15 11 61314-144-15 Brimonidine Tartrate 1 in 1 CARTON SOLUTION 1 11
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded BRIMONIDINE TARTRATE ACTIVE INGREDIENT 4S9CL2DY2H BRIMONIDINE TARTRATE SOLUTION [SANDOZ INC] 7 BRIMONIDINE ACTIVE MOIETY E6GNX3HHTE BRIMONIDINE TARTRATE SOLUTION [SANDOZ INC] 7 BORIC ACID INACTIVE INGREDIENT R57ZHV85D4 BRIMONIDINE TARTRATE SOLUTION [SANDOZ INC] 7 CALCIUM CHLORIDE INACTIVE INGREDIENT M4I0D6VV5M BRIMONIDINE TARTRATE SOLUTION [SANDOZ INC] 7 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB BRIMONIDINE TARTRATE SOLUTION [SANDOZ INC] 7 MANNITOL INACTIVE INGREDIENT 3OWL53L36A BRIMONIDINE TARTRATE SOLUTION [SANDOZ INC] 7 POTASSIUM CHLORIDE INACTIVE INGREDIENT 660YQ98I10 BRIMONIDINE TARTRATE SOLUTION [SANDOZ INC] 7 POVIDONES INACTIVE INGREDIENT FZ989GH94E BRIMONIDINE TARTRATE SOLUTION [SANDOZ INC] 7 SODIUM BORATE INACTIVE INGREDIENT 91MBZ8H3QO BRIMONIDINE TARTRATE SOLUTION [SANDOZ INC] 7 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X BRIMONIDINE TARTRATE SOLUTION [SANDOZ INC] 7 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I BRIMONIDINE TARTRATE SOLUTION [SANDOZ INC] 7 WATER INACTIVE INGREDIENT 059QF0KO0R BRIMONIDINE TARTRATE SOLUTION [SANDOZ INC] 7 BRIMONIDINE TARTRATE ACTIVE INGREDIENT 4S9CL2DY2H BRIMONIDINE TARTRATE SOLUTION [PHYSICIANS TOTAL CARE, INC.] 1 BRIMONIDINE ACTIVE MOIETY E6GNX3HHTE BRIMONIDINE TARTRATE SOLUTION [PHYSICIANS TOTAL CARE, INC.] 1 BORIC ACID INACTIVE INGREDIENT R57ZHV85D4 BRIMONIDINE TARTRATE SOLUTION [PHYSICIANS TOTAL CARE, INC.] 1 CALCIUM CHLORIDE INACTIVE INGREDIENT M4I0D6VV5M BRIMONIDINE TARTRATE SOLUTION [PHYSICIANS TOTAL CARE, INC.] 1 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB BRIMONIDINE TARTRATE SOLUTION [PHYSICIANS TOTAL CARE, INC.] 1 MAGNESIUM CHLORIDE INACTIVE INGREDIENT 02F3473H9O BRIMONIDINE TARTRATE SOLUTION [PHYSICIANS TOTAL CARE, INC.] 1 MANNITOL INACTIVE INGREDIENT 3OWL53L36A BRIMONIDINE TARTRATE SOLUTION [PHYSICIANS TOTAL CARE, INC.] 1 POTASSIUM CHLORIDE INACTIVE INGREDIENT 660YQ98I10 BRIMONIDINE TARTRATE SOLUTION [PHYSICIANS TOTAL CARE, INC.] 1 POVIDONE INACTIVE INGREDIENT FZ989GH94E BRIMONIDINE TARTRATE SOLUTION [PHYSICIANS TOTAL CARE, INC.] 1 SODIUM BORATE INACTIVE INGREDIENT 91MBZ8H3QO BRIMONIDINE TARTRATE SOLUTION [PHYSICIANS TOTAL CARE, INC.] 1 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X BRIMONIDINE TARTRATE SOLUTION [PHYSICIANS TOTAL CARE, INC.] 1 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I BRIMONIDINE TARTRATE SOLUTION [PHYSICIANS TOTAL CARE, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R BRIMONIDINE TARTRATE SOLUTION [PHYSICIANS TOTAL CARE, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61314-144 BRIMONIDINE TARTRATE SOLUTION [SANDOZ INC] 10 Current NDC, Legacy NDC, 6 package rows 20220216_b1e7ebd4-d0d2-40a5-aa11-5f68bc5972bd.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 61314-144-05 61314014405 1 BOTTLE in 1 CARTON (61314-144-05) / 5 mL in 1 BOTTLE 1 bottle 2010-10-02 0000-00-00 No No Current 61314-144-10 61314014410 1 BOTTLE in 1 CARTON (61314-144-10) / 10 mL in 1 BOTTLE 1 bottle 2010-10-02 0000-00-00 No No Current 61314-144-15 61314014415 1 BOTTLE in 1 CARTON (61314-144-15) / 15 mL in 1 BOTTLE 1 bottle 2010-10-02 0000-00-00 No No Current