SIMBRINZA

Product NDC
0078-0904
11-digit product format
000780904
Labeler code
0078
Product ID
0078-0904_c2a9e73d-9414-489a-9840-aa8aae4cdd00
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
brinzolamide/brimonidine tartrate
Dosage form
SUSPENSION/ DROPS
Route
OPHTHALMIC
Labeler
Novartis Pharmaceuticals Corporation
Application
NDA204251
Marketing category
NDA
Marketing start
2013-05-01
Marketing end
2023-02-28
Substance
BRIMONIDINE TARTRATE; BRINZOLAMIDE
Active strength
2 mg/mL; mg/mL
Pharmacologic classes
Adrenergic alpha-Agonists [MoA], Carbonic Anhydrase Inhibitor [EPC], Carbonic Anhydrase Inhibitors [MoA], alpha-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0078-0904-38000780904381 BOTTLE in 1 CARTON (0078-0904-38) > 8 mL in 1 BOTTLE1 bottle2020-08-040000-00-00NoNoCurrent
0078-0904-98000780904981 BOTTLE in 1 CARTON (0078-0904-98) > 2.5 mL in 1 BOTTLE1 bottle2020-08-040000-00-00YesNoCurrent