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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BRIMONIDINE TARTRATE5 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4S9CL2DY2H
Rxcui1437707

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
63629-9616-1BRIMONIDINE30 g in 1 BOTTLE, PUMPGEL30100
63629-9616-1BRIMONIDINE1 in 1 CARTONGEL1100

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-9616-1GM - Gram63629-96167a345c95-b345-43ef-a8a9-c102977ed77412023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-9616BRIMONIDINE GEL [BRYANT RANCH PREPACK]100Current NDC, 2 package rows20230204_9f17bf0c-d880-4328-bf92-00ac81d02fd1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1437707brimonidine 0.33 % Topical GelPSN9f17bf0c-d880-4328-bf92-00ac81d02fd1100
1437707brimonidine 0.0033 MG/MG Topical GelSCD9f17bf0c-d880-4328-bf92-00ac81d02fd1100
1437707brimonidine 0.33 % (as brimonidine tartrate) Topical GelSY9f17bf0c-d880-4328-bf92-00ac81d02fd1100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
63629-9616-1636299616011 BOTTLE, PUMP in 1 CARTON (63629-9616-1) / 30 g in 1 BOTTLE, PUMP2023-02-03NoNoHistorical