Azopt

Product NDC
0078-0722
11-digit product format
000780722
Labeler code
0078
Product ID
0078-0722_4a9f4516-bb9d-49a5-a8c6-fcd82063b63f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
brinzolamide
Dosage form
SUSPENSION/ DROPS
Route
OPHTHALMIC
Labeler
Novartis Pharmaceuticals Corporation
Application
NDA020816
Marketing category
NDA
Marketing start
1998-04-30
Marketing end
0000-00-00
Substance
BRINZOLAMIDE
Active strength
10 mg/mL
Pharmacologic classes
Carbonic Anhydrase Inhibitor [EPC], Carbonic Anhydrase Inhibitors [MoA]
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
0078-0722-10ML - Milliliter0078-0722f45282a0-084b-4497-ac5b-055cdf19041e12022-04-06
0078-0722-15ML - Milliliter0078-0722cab44eb7-aed5-4b3c-a884-4bc70188173012022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0078-0722AZOPT (BRINZOLAMIDE) SUSPENSION/ DROPS [NOVARTIS PHARMACEUTICALS CORPORATION]4Legacy NDC20230708_acc89925-3ee3-4632-98ae-38a546848346.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0078-0722-10000780722101 BOTTLE in 1 CARTON (0078-0722-10) > 10 mL in 1 BOTTLE1 bottle2021-12-240000-00-00NoNoCurrent
0078-0722-15000780722151 BOTTLE in 1 CARTON (0078-0722-15) > 15 mL in 1 BOTTLE1 bottle2021-12-240000-00-00NoNoCurrent