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

Additional Listing Data#

Finished product
Yes
Brand name base
Mirvaso
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BRIMONIDINE TARTRATE5 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4S9CL2DY2H
Rxcui1437707, 1437709

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6c0c444-a6ba-2fb5-a7bc-7f0443fa5791Product name420251208
8ec6541e-9842-115f-62bf-f7c9ab3aeddbProduct name320250805
39b7fcf4-8865-6d40-d24d-9b8c28bd6345Product name520250123
c93ffd9a-5bad-44d8-b5e5-16ef4d2fee72Product name120220316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0299-5980-00Mirvaso2 g in 1 TUBEGEL211
0299-5980-00Mirvaso1 in 1 BLISTER PACKGEL111
0299-5980-02Mirvaso2 g in 1 TUBEGEL211
0299-5980-30Mirvaso30 g in 1 TUBEGEL3011
0299-5980-35Mirvaso1 in 1 CARTONGEL111
0299-5980-35Mirvaso30 g in 1 BOTTLE, PUMPGEL3011
0299-5980-45Mirvaso45 g in 1 TUBEGEL4511

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0299-5980-30GM - Gram0299-598042f4938f-c58a-4e65-9729-88ba63bd1bdd12013-10-17
0299-5980-35GM - Gram0299-59804f970974-f73d-4fcf-a02b-5b9a9c7133b912016-06-14

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0299-5980MIRVASO (BRIMONIDINE TARTRATE) GEL [GALDERMA LABORATORIES, L.P.]11Current NDC, Legacy NDC, 7 package rows20241027_f6a4353f-ae69-4214-901f-e5d42a6fbde7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1437707brimonidine 0.33 % Topical GelPSNf6a4353f-ae69-4214-901f-e5d42a6fbde711
1437709Mirvaso 0.33 % Topical GelPSNf6a4353f-ae69-4214-901f-e5d42a6fbde711
1437709brimonidine 0.0033 MG/MG Topical Gel [Mirvaso]SBDf6a4353f-ae69-4214-901f-e5d42a6fbde711
1437707brimonidine 0.0033 MG/MG Topical GelSCDf6a4353f-ae69-4214-901f-e5d42a6fbde711
1437707brimonidine 0.33 % (as brimonidine tartrate) Topical GelSYf6a4353f-ae69-4214-901f-e5d42a6fbde711
1437709Mirvaso 0.0033 MG/MG Topical GelSYf6a4353f-ae69-4214-901f-e5d42a6fbde711
1437709Mirvaso 0.33 % (as brimonidine tartrate 5 mg/ml) Topical GelSYf6a4353f-ae69-4214-901f-e5d42a6fbde711

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0299-5980-00002995980001 TUBE in 1 BLISTER PACK (0299-5980-00) / 2 g in 1 TUBE1 tube2013-08-230000-00-00YesNoCurrent
0299-5980-02002995980022 g in 1 TUBE (0299-5980-02) 2 g2013-08-230000-00-00YesNoCurrent
0299-5980-300029959803030 g in 1 TUBE (0299-5980-30) 30 g2013-08-230000-00-00NoNoCurrent
0299-5980-35002995980351 BOTTLE, PUMP in 1 CARTON (0299-5980-35) / 30 g in 1 BOTTLE, PUMP2013-08-230000-00-00NoNoCurrent
0299-5980-450029959804545 g in 1 TUBE (0299-5980-45) 45 g2013-08-230000-00-00NoNoCurrent