DUREZOL

Product NDC
0078-0862
11-digit product format
000780862
Labeler code
0078
Product ID
0078-0862_830dd64e-8b1a-4bc4-86bd-e0a0915b59e7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
difluprednate
Dosage form
EMULSION
Route
OPHTHALMIC
Labeler
Novartis Pharmaceuticals Corporation
Application
NDA022212
Marketing category
NDA
Marketing start
2011-01-25
Marketing end
0000-00-00
Substance
DIFLUPREDNATE
Active strength
1 mg/mL
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
05bd5167-c8bb-b60b-f647-c2bfd6944eb3Product name520260107
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0078-0862-25ML - Milliliter0078-0862988f3d5c-df6d-4cad-b039-bb7ed412087b12023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0078-0862DUREZOL (DIFLUPREDNATE) EMULSION [NOVARTIS PHARMACEUTICALS CORPORATION]2Legacy NDC20230628_830dd64e-8b1a-4bc4-86bd-e0a0915b59e7.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0078-0862-25000780862251 BOTTLE in 1 CARTON (0078-0862-25) > 5 mL in 1 BOTTLE1 bottle2022-07-050000-00-00NoNoCurrent