FDA.reportPublic FDA data

ALPHAGAN P

Product NDC
0023-9321
11-digit product format
000239321
Labeler code
0023
Product ID
0023-9321_f1dec1d6-7362-407f-abe3-c119c55832ef
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
brimonidine tartrate
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Allergan, Inc.
Application
NDA021770
Marketing category
NDA
Marketing start
2006-01-25
Substance
BRIMONIDINE TARTRATE
Active strength
1 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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BRIMONIDINE TARTRATE1 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4S9CL2DY2H
Rxcui861204, 861206, 861208, 861210

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
c6c0c444-a6ba-2fb5-a7bc-7f0443fa5791Product name420251208
8ec6541e-9842-115f-62bf-f7c9ab3aeddbProduct name320250805
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
39b7fcf4-8865-6d40-d24d-9b8c28bd6345Product name520250123
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
c93ffd9a-5bad-44d8-b5e5-16ef4d2fee72Product name120220316
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0023-9321-03ALPHAGAN P1 in 1 CARTONSOLUTION/ DROPS124
0023-9321-03ALPHAGAN P3 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS324
0023-9321-05ALPHAGAN P1 in 1 CARTONSOLUTION/ DROPS124
0023-9321-05ALPHAGAN P5 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS524
0023-9321-10ALPHAGAN P1 in 1 CARTONSOLUTION/ DROPS124
0023-9321-10ALPHAGAN P10 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS1024
0023-9321-15ALPHAGAN P15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS1524
0023-9321-15ALPHAGAN P1 in 1 CARTONSOLUTION/ DROPS124

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0023-9321-05ML - Milliliter0023-93215f93815f-ebe6-44fb-8462-b0274116eb9c12012-07-24
0023-9321-10ML - Milliliter0023-9321fd89ebce-6142-472f-9785-ea377bb592e612012-07-24
0023-9321-15ML - Milliliter0023-93219c1b17d8-4702-408f-9f16-cf1859770e1c12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
brimonidine tartrateACTIVE INGREDIENT4S9CL2DY2HALPHAGAN P (BRIMONIDINE TARTRATE) SOLUTION/ DROPS [ALLERGAN, INC. ]10
brimonidineACTIVE MOIETYE6GNX3HHTEALPHAGAN P (BRIMONIDINE TARTRATE) SOLUTION/ DROPS [ALLERGAN, INC. ]10
boric acidINACTIVE INGREDIENTR57ZHV85D4ALPHAGAN P (BRIMONIDINE TARTRATE) SOLUTION/ DROPS [ALLERGAN, INC. ]10
calcium chlorideINACTIVE INGREDIENTM4I0D6VV5MALPHAGAN P (BRIMONIDINE TARTRATE) SOLUTION/ DROPS [ALLERGAN, INC. ]10
carboxymethylcellulose sodiumINACTIVE INGREDIENTK679OBS311ALPHAGAN P (BRIMONIDINE TARTRATE) SOLUTION/ DROPS [ALLERGAN, INC. ]10
hydrochloric acidINACTIVE INGREDIENTQTT17582CBALPHAGAN P (BRIMONIDINE TARTRATE) SOLUTION/ DROPS [ALLERGAN, INC. ]10
magnesium chlorideINACTIVE INGREDIENT02F3473H9OALPHAGAN P (BRIMONIDINE TARTRATE) SOLUTION/ DROPS [ALLERGAN, INC. ]10
potassium chlorideINACTIVE INGREDIENT660YQ98I10ALPHAGAN P (BRIMONIDINE TARTRATE) SOLUTION/ DROPS [ALLERGAN, INC. ]10
sodium borateINACTIVE INGREDIENT91MBZ8H3QOALPHAGAN P (BRIMONIDINE TARTRATE) SOLUTION/ DROPS [ALLERGAN, INC. ]10
sodium chlorideINACTIVE INGREDIENT451W47IQ8XALPHAGAN P (BRIMONIDINE TARTRATE) SOLUTION/ DROPS [ALLERGAN, INC. ]10
sodium hydroxideINACTIVE INGREDIENT55X04QC32IALPHAGAN P (BRIMONIDINE TARTRATE) SOLUTION/ DROPS [ALLERGAN, INC. ]10
waterINACTIVE INGREDIENT059QF0KO0RALPHAGAN P (BRIMONIDINE TARTRATE) SOLUTION/ DROPS [ALLERGAN, INC. ]10
brimonidine tartrateACTIVE INGREDIENT4S9CL2DY2HALPHAGAN P (BRIMONIDINE TARTRATE) SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]4
brimonidineACTIVE MOIETYE6GNX3HHTEALPHAGAN P (BRIMONIDINE TARTRATE) SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]4
boric acidINACTIVE INGREDIENTR57ZHV85D4ALPHAGAN P (BRIMONIDINE TARTRATE) SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]4
calcium chlorideINACTIVE INGREDIENTM4I0D6VV5MALPHAGAN P (BRIMONIDINE TARTRATE) SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]4
carboxymethylcellulose sodiumINACTIVE INGREDIENTK679OBS311ALPHAGAN P (BRIMONIDINE TARTRATE) SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]4
hydrochloric acidINACTIVE INGREDIENTQTT17582CBALPHAGAN P (BRIMONIDINE TARTRATE) SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]4
magnesium chlorideINACTIVE INGREDIENT02F3473H9OALPHAGAN P (BRIMONIDINE TARTRATE) SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]4
potassium chlorideINACTIVE INGREDIENT660YQ98I10ALPHAGAN P (BRIMONIDINE TARTRATE) SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]4
sodium borateINACTIVE INGREDIENT91MBZ8H3QOALPHAGAN P (BRIMONIDINE TARTRATE) SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]4
sodium chlorideINACTIVE INGREDIENT451W47IQ8XALPHAGAN P (BRIMONIDINE TARTRATE) SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]4
sodium hydroxideINACTIVE INGREDIENT55X04QC32IALPHAGAN P (BRIMONIDINE TARTRATE) SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]4
waterINACTIVE INGREDIENT059QF0KO0RALPHAGAN P (BRIMONIDINE TARTRATE) SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0023-9321ALPHAGAN P (BRIMONIDINE TARTRATE) SOLUTION/ DROPS [ALLERGAN, INC.]23Current NDC, Legacy NDC, 8 package rows20250424_264c4494-c225-486f-888a-caaf36be46b3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861206Alphagan P 0.1 % Ophthalmic SolutionPSN264c4494-c225-486f-888a-caaf36be46b324
861210Alphagan P 0.15 % Ophthalmic SolutionPSN264c4494-c225-486f-888a-caaf36be46b324
861204brimonidine tartrate 0.1 % Ophthalmic SolutionPSN264c4494-c225-486f-888a-caaf36be46b324
861208brimonidine tartrate 0.15 % Ophthalmic SolutionPSN264c4494-c225-486f-888a-caaf36be46b324
861206brimonidine tartrate 1 MG/ML Ophthalmic Solution [Alphagan]SBD264c4494-c225-486f-888a-caaf36be46b324
861210brimonidine tartrate 1.5 MG/ML Ophthalmic Solution [Alphagan]SBD264c4494-c225-486f-888a-caaf36be46b324
861204brimonidine tartrate 1 MG/ML Ophthalmic SolutionSCD264c4494-c225-486f-888a-caaf36be46b324
861208brimonidine tartrate 1.5 MG/ML Ophthalmic SolutionSCD264c4494-c225-486f-888a-caaf36be46b324
861206Alphagan 1 MG/ML Ophthalmic SolutionSY264c4494-c225-486f-888a-caaf36be46b324
861210Alphagan 1.5 MG/ML Ophthalmic SolutionSY264c4494-c225-486f-888a-caaf36be46b324
861206Alphagan P 0.1 % Ophthalmic DropsSY264c4494-c225-486f-888a-caaf36be46b324
861210Alphagan P 0.15 % Ophthalmic DropsSY264c4494-c225-486f-888a-caaf36be46b324
861204brimonidine tartrate 0.1 % Ophthalmic SolutionSY264c4494-c225-486f-888a-caaf36be46b324
861208brimonidine tartrate 0.15 % Ophthalmic DropsSY264c4494-c225-486f-888a-caaf36be46b324
861206Alphagan P 0.1 % Ophthalmic SolutionPSNba15fa83-c808-4298-bb0e-43ed1429c5264
861210Alphagan P 0.15 % Ophthalmic SolutionPSNba15fa83-c808-4298-bb0e-43ed1429c5264
861204brimonidine tartrate 0.1 % Ophthalmic SolutionPSNba15fa83-c808-4298-bb0e-43ed1429c5264
861208brimonidine tartrate 0.15 % Ophthalmic SolutionPSNba15fa83-c808-4298-bb0e-43ed1429c5264
861206brimonidine tartrate 1 MG/ML Ophthalmic Solution [Alphagan]SBDba15fa83-c808-4298-bb0e-43ed1429c5264
861210brimonidine tartrate 1.5 MG/ML Ophthalmic Solution [Alphagan]SBDba15fa83-c808-4298-bb0e-43ed1429c5264
861204brimonidine tartrate 1 MG/ML Ophthalmic SolutionSCDba15fa83-c808-4298-bb0e-43ed1429c5264
861208brimonidine tartrate 1.5 MG/ML Ophthalmic SolutionSCDba15fa83-c808-4298-bb0e-43ed1429c5264
861206Alphagan 1 MG/ML Ophthalmic SolutionSYba15fa83-c808-4298-bb0e-43ed1429c5264
861210Alphagan 1.5 MG/ML Ophthalmic SolutionSYba15fa83-c808-4298-bb0e-43ed1429c5264
861206Alphagan P 0.1 % Ophthalmic DropsSYba15fa83-c808-4298-bb0e-43ed1429c5264
861210Alphagan P 0.15 % Ophthalmic DropsSYba15fa83-c808-4298-bb0e-43ed1429c5264
861204brimonidine tartrate 0.1 % Ophthalmic SolutionSYba15fa83-c808-4298-bb0e-43ed1429c5264
861208brimonidine tartrate 0.15 % Ophthalmic DropsSYba15fa83-c808-4298-bb0e-43ed1429c5264

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0023-9321-03000239321031 BOTTLE, DROPPER in 1 CARTON (0023-9321-03) / 3 mL in 1 BOTTLE, DROPPER2006-01-250000-00-00NoNoCurrent
0023-9321-05000239321051 BOTTLE, DROPPER in 1 CARTON (0023-9321-05) / 5 mL in 1 BOTTLE, DROPPER2006-01-250000-00-00NoNoCurrent
0023-9321-10000239321101 BOTTLE, DROPPER in 1 CARTON (0023-9321-10) / 10 mL in 1 BOTTLE, DROPPER2006-01-250000-00-00NoNoCurrent
0023-9321-15000239321151 BOTTLE, DROPPER in 1 CARTON (0023-9321-15) / 15 mL in 1 BOTTLE, DROPPER2006-01-250000-00-00NoNoCurrent