BRIMONIDINE TARTRATE and TIMOLOL MALEATE

Product NDC
82182-455
11-digit product format
821820455
Labeler code
82182
Product ID
82182-455_d25cce44-22ca-4129-8ed9-6c363a50e560
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BRIMONIDINE TARTRATE, TIMOLOL MALEATE
Dosage form
SOLUTION/ DROPS
Route
TOPICAL
Labeler
Pacific Pharma, Inc.
Application
NDA021398
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2022-10-21
Marketing end
0000-00-00
Substance
BRIMONIDINE TARTRATE; TIMOLOL MALEATE
Active strength
2 mg/mL; mg/mL
Pharmacologic classes
Adrenergic alpha-Agonists [MoA], Adrenergic beta-Antagonists [MoA], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6c0c444-a6ba-2fb5-a7bc-7f0443fa5791Product name420251208
8ec6541e-9842-115f-62bf-f7c9ab3aeddbProduct name320250805
73103a56-9f57-4f32-a306-a42bfa2fea36Product name120250505
425025fc-f910-4afe-815b-58d4486ed4f7Product name420250331
26c5ddae-5c69-622d-e599-5fd583634968Product name420250313
ee780602-134c-4c60-a2f0-e973ba549cd4Product name220250304
39b7fcf4-8865-6d40-d24d-9b8c28bd6345Product name520250123
03f77cb2-b4ad-3c11-8781-787b5ece4291Product name320240507
273981e4-09e7-45cc-967c-554f628ededfProduct name320230627
97dad5a2-c524-a7b5-dede-82edefe9ce62Product name720220929
c93ffd9a-5bad-44d8-b5e5-16ef4d2fee72Product name120220316
d11e749b-f93e-0ce3-ceda-28fe03d8081dProduct name220190731

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82182-455-05ML - Milliliter82182-45553dccda7-9b12-4d98-a10f-c942887fd6e012022-11-07
82182-455-10ML - Milliliter82182-45594a25136-f273-453a-ad50-3439b35c7e9112022-11-07
82182-455-15ML - Milliliter82182-45542ec7cbd-da72-4a1a-a416-1c8cd8195fae12022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82182-455BRIMONIDINE TARTRATE AND TIMOLOL MALEATE (BRIMONIDINE TARTRATE, TIMOLOL MALEATE) SOLUTION/ DROPS [PACIFIC PHARMA, INC.]4Legacy NDC20240802_8b13bd5a-b65f-4e39-83f1-8d3abe97d4c0.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
82182-455-05821820455055 mL in 1 BOTTLE, PLASTIC (82182-455-05) 5 ml2022-10-210000-00-00NoNoCurrent
82182-455-108218204551010 mL in 1 BOTTLE, PLASTIC (82182-455-10) 10 ml2022-10-210000-00-00NoNoCurrent
82182-455-158218204551515 mL in 1 BOTTLE, PLASTIC (82182-455-15) 15 ml2022-10-210000-00-00NoNoCurrent