Maxidex

Product NDC
0078-0925
11-digit product format
000780925
Labeler code
0078
Product ID
0078-0925_603f0bac-16b8-42f5-985e-fb0d73ee284d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dexamethasone
Dosage form
SUSPENSION/ DROPS
Route
OPHTHALMIC
Labeler
Novartis Pharmaceuticals Corporation
Application
NDA013422
Marketing category
NDA
Marketing start
1966-05-15
Marketing end
0000-00-00
Substance
DEXAMETHASONE
Active strength
1 mg/mL
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0078-0925-252025-05-02C16284748780-12cef2736-6758-d83d-e063-dadaa90ab31f603f0bac-16b8-42f5-985e-fb0d73ee284d
0078-0925-252025-01-30C16284748780-12cef2736-6758-d83d-e063-dadaa90ab31f603f0bac-16b8-42f5-985e-fb0d73ee284d

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0078-0925-25ML - Milliliter0078-0925033b5d8d-b7de-41fe-82f1-9da9534d06de12022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0078-0925MAXIDEX (DEXAMETHASONE) SUSPENSION/ DROPS [NOVARTIS PHARMACEUTICALS CORPORATION]3Legacy NDC20250504_603f0bac-16b8-42f5-985e-fb0d73ee284d.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0078-0925-25000780925255 mL in 1 BOTTLE (0078-0925-25) 5 ml2022-07-050000-00-00NoNoCurrent