Home NDC 0299-5980 Mirvaso
Product NDC 0299-5980
11-digit product format 002995980
Labeler code 0299
Product ID 0299-5980_253bf4a2-3c4d-f4af-e063-6394a90a0b0a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name brimonidine tartrate
Dosage form GEL
Route TOPICAL
Labeler Galderma Laboratories, L.P.
Application NDA204708
Marketing category NDA
Marketing start 2013-08-23
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 1 .
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 N204708-001 MIRVASO BRIMONIDINE TARTRATE EQ 0.33% BASE GEL / TOPICAL AB RLD, RS 2013-08-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N204708-001 AB
Orange Book patents# Current patent rows page 1 of 1 · 7 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N204708-001 8513247 2031-03-25 U-1428 Drug product 2013-09-13 N204708-001 8513249 2031-03-25 U-1428 Drug product 2013-09-13 N204708-001 9861631 2031-03-25 U-1428 2018-01-25 N204708-001 9861632 2031-03-25 U-1428 2018-01-25 N204708-001 10201517 2031-06-13 Drug product 2019-02-13 N204708-001 8053427 2031-06-13 U-1428 Drug product 2013-09-13 N204708-001 8163725 2031-06-13 Drug product 2013-09-13
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 · 41 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 2026-02-19 14:30 UTC 2026-02 N204708-001 MIRVASO EQ 0.33% BASE GEL / TOPICAL AB RLD, RS 2013-08-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204708-001 MIRVASO EQ 0.33% BASE GEL / TOPICAL AB RLD, RS 2013-08-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N204708-001 MIRVASO EQ 0.33% BASE GEL / TOPICAL AB RLD, RS 2013-08-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204708-001 MIRVASO EQ 0.33% BASE GEL / TOPICAL AB RLD, RS 2013-08-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204708-001 MIRVASO EQ 0.33% BASE GEL / TOPICAL AB RLD, RS 2013-08-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204708-001 MIRVASO EQ 0.33% BASE GEL / TOPICAL AB RLD, RS 2013-08-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N204708-001 MIRVASO EQ 0.33% BASE GEL / TOPICAL AB RLD, RS 2013-08-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N204708-001 MIRVASO EQ 0.33% BASE GEL / TOPICAL AB RLD, RS 2013-08-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N204708-001 MIRVASO EQ 0.33% BASE GEL / TOPICAL AB RLD, RS 2013-08-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N204708-001 MIRVASO EQ 0.33% BASE GEL / TOPICAL AB RLD, RS 2013-08-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N204708-001 MIRVASO EQ 0.33% BASE GEL / TOPICAL AB RLD, RS 2013-08-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N204708-001 MIRVASO EQ 0.33% BASE GEL / TOPICAL AB RLD, RS 2013-08-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N204708-001 MIRVASO EQ 0.33% BASE GEL / TOPICAL AB RLD, RS 2013-08-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N204708-001 MIRVASO EQ 0.33% BASE GEL / TOPICAL AB RLD, RS 2013-08-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N204708-001 MIRVASO EQ 0.33% BASE GEL / TOPICAL RLD, RS 2013-08-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N204708-001 MIRVASO EQ 0.33% BASE GEL / TOPICAL AB RLD, RS 2013-08-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N204708-001 MIRVASO EQ 0.33% BASE GEL / TOPICAL AB RLD, RS 2013-08-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N204708-001 MIRVASO EQ 0.33% BASE GEL / TOPICAL RLD, RS 2013-08-23 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N204708-001 MIRVASO EQ 0.33% BASE GEL / TOPICAL AB RLD, RS 2013-08-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N204708-001 MIRVASO EQ 0.33% BASE GEL / TOPICAL AB RLD, RS 2013-08-23 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N204708-001 MIRVASO EQ 0.33% BASE GEL / TOPICAL RLD, RS 2013-08-23 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N204708-001 MIRVASO EQ 0.33% BASE GEL / TOPICAL RLD, RS 2013-08-23 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N204708-001 MIRVASO EQ 0.33% BASE GEL / TOPICAL RLD, RS 2013-08-23 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N204708-001 MIRVASO EQ 0.33% BASE GEL / TOPICAL RLD, RS 2013-08-23 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N204708-001 MIRVASO EQ 0.33% BASE GEL / TOPICAL RLD, RS 2013-08-23 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N204708-001 MIRVASO EQ 0.33% BASE GEL / TOPICAL RLD, RS 2013-08-23 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N204708-001 MIRVASO EQ 0.33% BASE GEL / TOPICAL RLD, RS 2013-08-23 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N204708-001 MIRVASO EQ 0.33% BASE GEL / TOPICAL AB RLD, RS 2013-08-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N204708-001 MIRVASO EQ 0.33% BASE GEL / TOPICAL AB RLD, RS 2013-08-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N204708-001 MIRVASO EQ 0.33% BASE GEL / TOPICAL AB RLD, RS 2013-08-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N204708-001 MIRVASO EQ 0.33% BASE GEL / TOPICAL AB RLD, RS 2013-08-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N204708-001 MIRVASO EQ 0.33% BASE GEL / TOPICAL AB RLD, RS 2013-08-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N204708-001 MIRVASO EQ 0.33% BASE GEL / TOPICAL AB RLD, RS 2013-08-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N204708-001 MIRVASO EQ 0.33% BASE GEL / TOPICAL AB RLD, RS 2013-08-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N204708-001 MIRVASO EQ 0.33% BASE GEL / TOPICAL AB RLD, RS 2013-08-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N204708-001 MIRVASO EQ 0.33% BASE GEL / TOPICAL AB RLD, RS 2013-08-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N204708-001 MIRVASO EQ 0.33% BASE GEL / TOPICAL RLD, RS 2013-08-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N204708-001 MIRVASO EQ 0.33% BASE GEL / TOPICAL RLD, RS 2013-08-23 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N204708-001 MIRVASO EQ 0.33% BASE GEL / TOPICAL RLD, RS 2013-08-23 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N204708-001 MIRVASO EQ 0.33% BASE GEL / TOPICAL RLD, RS 2013-08-23 cb3db0bc1861…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 12 · 478 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N204708-001 8513247 2031-03-25 U-1428 Drug product 2013-09-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204708-001 8513249 2031-03-25 U-1428 Drug product 2013-09-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204708-001 9861631 2031-03-25 U-1428 2018-01-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204708-001 9861632 2031-03-25 U-1428 2018-01-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204708-001 10201517 2031-06-13 Drug product 2019-02-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204708-001 8053427 2031-06-13 U-1428 Drug product 2013-09-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204708-001 8163725 2031-06-13 Drug product 2013-09-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204708-001 8231885 2025-05-24 Drug product 2013-09-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204708-001 8410102 2025-05-24 U-1428 2013-09-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204708-001 8426410 2025-05-24 U-1428 2013-09-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204708-001 7439241 2025-08-25 U-1428 2013-09-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204708-001 8513247 2031-03-25 U-1428 Drug product 2013-09-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204708-001 8513249 2031-03-25 U-1428 Drug product 2013-09-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204708-001 9861631 2031-03-25 U-1428 2018-01-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204708-001 9861632 2031-03-25 U-1428 2018-01-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204708-001 10201517 2031-06-13 Drug product 2019-02-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204708-001 8053427 2031-06-13 U-1428 Drug product 2013-09-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204708-001 8163725 2031-06-13 Drug product 2013-09-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N204708-001 8231885 2025-05-24 Drug product 2013-09-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204708-001 8410102 2025-05-24 U-1428 2013-09-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204708-001 8426410 2025-05-24 U-1428 2013-09-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204708-001 7439241 2025-08-25 U-1428 2013-09-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204708-001 8513247 2031-03-25 U-1428 Drug product 2013-09-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204708-001 8513249 2031-03-25 U-1428 Drug product 2013-09-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204708-001 9861631 2031-03-25 U-1428 2018-01-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204708-001 9861632 2031-03-25 U-1428 2018-01-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204708-001 10201517 2031-06-13 Drug product 2019-02-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204708-001 8053427 2031-06-13 U-1428 Drug product 2013-09-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204708-001 8163725 2031-06-13 Drug product 2013-09-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204708-001 8231885 2025-05-24 Drug product 2013-09-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204708-001 8410102 2025-05-24 U-1428 2013-09-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204708-001 8426410 2025-05-24 U-1428 2013-09-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204708-001 7439241 2025-08-25 U-1428 2013-09-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204708-001 8513247 2031-03-25 U-1428 Drug product 2013-09-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204708-001 8513249 2031-03-25 U-1428 Drug product 2013-09-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204708-001 9861631 2031-03-25 U-1428 2018-01-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204708-001 9861632 2031-03-25 U-1428 2018-01-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204708-001 10201517 2031-06-13 Drug product 2019-02-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204708-001 8053427 2031-06-13 U-1428 Drug product 2013-09-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204708-001 8163725 2031-06-13 Drug product 2013-09-13 fd3edfee7708…
Additional Listing Data#
Finished product Yes
Brand name base Mirvaso
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1437707 Internal RxNorm lookup 1437709 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded BRIMONIDINE TARTRATE ACTIVE INGREDIENT 4S9CL2DY2H MIRVASO (BRIMONIDINE TARTRATE) GEL [GALDERMA LABORATORIES, L.P.] 6 BRIMONIDINE ACTIVE MOIETY E6GNX3HHTE MIRVASO (BRIMONIDINE TARTRATE) GEL [GALDERMA LABORATORIES, L.P.] 6 Carbomer Homopolymer Type B (allyl Pentaerythritol Crosslinked) INACTIVE INGREDIENT HHT01ZNK31 MIRVASO (BRIMONIDINE TARTRATE) GEL [GALDERMA LABORATORIES, L.P.] 6 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX MIRVASO (BRIMONIDINE TARTRATE) GEL [GALDERMA LABORATORIES, L.P.] 6 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T MIRVASO (BRIMONIDINE TARTRATE) GEL [GALDERMA LABORATORIES, L.P.] 6 PHENOXYETHANOL INACTIVE INGREDIENT HIE492ZZ3T MIRVASO (BRIMONIDINE TARTRATE) GEL [GALDERMA LABORATORIES, L.P.] 6 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 MIRVASO (BRIMONIDINE TARTRATE) GEL [GALDERMA LABORATORIES, L.P.] 6 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I MIRVASO (BRIMONIDINE TARTRATE) GEL [GALDERMA LABORATORIES, L.P.] 6 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP MIRVASO (BRIMONIDINE TARTRATE) GEL [GALDERMA LABORATORIES, L.P.] 6 WATER INACTIVE INGREDIENT 059QF0KO0R MIRVASO (BRIMONIDINE TARTRATE) GEL [GALDERMA LABORATORIES, L.P.] 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0299-5980 MIRVASO (BRIMONIDINE TARTRATE) GEL [GALDERMA LABORATORIES, L.P.] 11 Current NDC, Legacy NDC, 7 package rows 20241027_f6a4353f-ae69-4214-901f-e5d42a6fbde7.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Mirvaso BRIMONIDINE TARTRATE Galderma Laboratories, L.P. f6a4353f-ae69-4214-901f-e5d42a6fbde7 2024-10-24 Warnings, Adverse reactions Exact identifier application applno (NDA): 204708 application number: NDA204708 ndc (product): 0299-5980
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 0299-5980-00 00299598000 1 TUBE in 1 BLISTER PACK (0299-5980-00) / 2 g in 1 TUBE 1 tube 2013-08-23 0000-00-00 Yes No Current 0299-5980-02 00299598002 2 g in 1 TUBE (0299-5980-02) 2 g 2013-08-23 0000-00-00 Yes No Current 0299-5980-30 00299598030 30 g in 1 TUBE (0299-5980-30) 30 g 2013-08-23 0000-00-00 No No Current 0299-5980-35 00299598035 1 BOTTLE, PUMP in 1 CARTON (0299-5980-35) / 30 g in 1 BOTTLE, PUMP 2013-08-23 0000-00-00 No No Current 0299-5980-45 00299598045 45 g in 1 TUBE (0299-5980-45) 45 g 2013-08-23 0000-00-00 No No Current