Brimonidine Tartrate/Timolol Maleate

Product NDC
0591-2422
11-digit product format
005912422
Labeler code
0591
Product ID
0591-2422_1d48bdb8-e47a-4716-a13a-49482fd45b5e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Brimonidine Tartrate and Timolol Maleate
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Actavis Pharma, Inc.
Application
ANDA201949
Marketing category
ANDA
Marketing start
2022-10-07
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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0591-2422-12ML - Milliliter0591-2422d7761cb9-134e-483f-b16f-82155a58cc6412022-11-07
0591-2422-26ML - Milliliter0591-24222be79a08-6d56-4d47-b63f-cfbc1af5015d12022-11-07
0591-2422-79ML - Milliliter0591-24225cb66cba-1c99-42fa-bf49-f4135a042d5d12022-11-07

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0591-2422-12005912422121 BOTTLE, DROPPER in 1 CARTON (0591-2422-12) > 15 mL in 1 BOTTLE, DROPPER2022-10-070000-00-00NoNoCurrent
0591-2422-26005912422261 BOTTLE, DROPPER in 1 CARTON (0591-2422-26) > 5 mL in 1 BOTTLE, DROPPER2022-10-070000-00-00NoNoCurrent
0591-2422-79005912422791 BOTTLE, DROPPER in 1 CARTON (0591-2422-79) > 10 mL in 1 BOTTLE, DROPPER2022-10-070000-00-00NoNoCurrent