Brimonidine Tartrate/Timolol Maleate

Product NDC
60505-6225
11-digit product format
605056225
Labeler code
60505
Product ID
60505-6225_27c9a4e3-a7a1-4294-8645-8f46bc529d71
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
brimonidine tartrate, timolol maleate
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Apotex Corp
Application
NDA021398
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2022-01-19
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
60505-6225-0ML - Milliliter60505-6225e4bbba07-0539-4ec7-8339-7ea5b30ee93212022-02-07
60505-6225-1ML - Milliliter60505-6225a31563ae-1fcd-4a52-bbeb-7a860103d0a712022-02-07
60505-6225-2ML - Milliliter60505-6225d0f5cd10-7280-4b72-b289-8bb6c5c86b3512022-02-07

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60505-6225-0605056225001 BOTTLE, DROPPER in 1 CARTON (60505-6225-0) > 5 mL in 1 BOTTLE, DROPPER2022-01-190000-00-00NoNoCurrent
60505-6225-1605056225011 BOTTLE, DROPPER in 1 CARTON (60505-6225-1) > 10 mL in 1 BOTTLE, DROPPER2022-01-190000-00-00NoNoCurrent
60505-6225-2605056225021 BOTTLE, DROPPER in 1 CARTON (60505-6225-2) > 15 mL in 1 BOTTLE, DROPPER2022-01-190000-00-00NoNoCurrent