Home NDC 0299-5980 Mirvaso
Product NDC 0299-5980
11-digit product format 002995980
Labeler code 0299
Product ID 0299-5980_bdcc950f-48b2-4243-8b9b-928aa7184e0d
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
Marketing end 2027-03-31
Substance BRIMONIDINE TARTRATE
Active strength 5 mg/g
Pharmacologic classes Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]
NDC exclude flag No
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 · 44 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 2026-10-15 13:18:30 2026-09 N204708-001 MIRVASO EQ 0.33% BASE GEL / TOPICAL AB RLD, RS 2013-08-23 c2088c7a36db…2026-09-14 22:38:34 2026-08 N204708-001 MIRVASO EQ 0.33% BASE GEL / TOPICAL AB RLD, RS 2013-08-23 84e616aacf4f…2026-08-18 06:07:40 2026-07 N204708-001 MIRVASO EQ 0.33% BASE GEL / TOPICAL AB RLD, RS 2013-08-23 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 13 · 499 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-10-15 13:18:30 2026-09 N204708-001 8513247 2031-03-25 U-1428 Drug product 2013-09-13 c2088c7a36db…2026-10-15 13:18:30 2026-09 N204708-001 8513249 2031-03-25 U-1428 Drug product 2013-09-13 c2088c7a36db…2026-10-15 13:18:30 2026-09 N204708-001 9861631 2031-03-25 U-1428 2018-01-25 c2088c7a36db…2026-10-15 13:18:30 2026-09 N204708-001 9861632 2031-03-25 U-1428 2018-01-25 c2088c7a36db…2026-10-15 13:18:30 2026-09 N204708-001 10201517 2031-06-13 Drug product 2019-02-13 c2088c7a36db…2026-10-15 13:18:30 2026-09 N204708-001 8053427 2031-06-13 U-1428 Drug product 2013-09-13 c2088c7a36db…2026-10-15 13:18:30 2026-09 N204708-001 8163725 2031-06-13 Drug product 2013-09-13 c2088c7a36db…2026-09-14 22:38:34 2026-08 N204708-001 8513247 2031-03-25 U-1428 Drug product 2013-09-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204708-001 8513249 2031-03-25 U-1428 Drug product 2013-09-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204708-001 9861631 2031-03-25 U-1428 2018-01-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204708-001 9861632 2031-03-25 U-1428 2018-01-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204708-001 10201517 2031-06-13 Drug product 2019-02-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204708-001 8053427 2031-06-13 U-1428 Drug product 2013-09-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204708-001 8163725 2031-06-13 Drug product 2013-09-13 84e616aacf4f…2026-08-18 06:07:40 2026-07 N204708-001 8513247 2031-03-25 U-1428 Drug product 2013-09-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204708-001 8513249 2031-03-25 U-1428 Drug product 2013-09-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204708-001 9861631 2031-03-25 U-1428 2018-01-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204708-001 9861632 2031-03-25 U-1428 2018-01-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204708-001 10201517 2031-06-13 Drug product 2019-02-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204708-001 8053427 2031-06-13 U-1428 Drug product 2013-09-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204708-001 8163725 2031-06-13 Drug product 2013-09-13 caaa826d4ba7…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…
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 Mirvaso Active Ingredients# Ingredient, Strength table Ingredient Strength BRIMONIDINE TARTRATE 5 mg/g
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
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 No No Current 0299-5980-02 00299598002 2 g in 1 TUBE (0299-5980-02) 2 g 2013-08-23 0000-00-00 No 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 2027-03-31 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