DUREZOL

Product NDC
0065-9240
11-digit product format
000659240
Labeler code
0065
Product ID
0065-9240_ff961dd4-e9a3-4a20-9a36-62319724d973
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DUREZOL
Dosage form
EMULSION
Route
OPHTHALMIC
Labeler
Alcon Laboratories, Inc.
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
0065-9240-05ML - Milliliter0065-924005a9c157-6cea-4718-8429-94f99fe3888112012-07-24
0065-9240-07ML - Milliliter0065-9240f10b2ebb-6680-4ff7-b334-4e35ef6f22e812013-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIFLUPREDNATEACTIVE INGREDIENTS8A06QG2QEDUREZOL EMULSION [PHYSICIANS TOTAL CARE, INC.]1
DIFLUPREDNATEACTIVE MOIETYS8A06QG2QEDUREZOL EMULSION [PHYSICIANS TOTAL CARE, INC.]1
BORIC ACIDINACTIVE INGREDIENTR57ZHV85D4DUREZOL EMULSION [PHYSICIANS TOTAL CARE, INC.]1
CASTOR OILINACTIVE INGREDIENTD5340Y2I9GDUREZOL EMULSION [PHYSICIANS TOTAL CARE, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDUREZOL EMULSION [PHYSICIANS TOTAL CARE, INC.]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HDUREZOL EMULSION [PHYSICIANS TOTAL CARE, INC.]1
SODIUM ACETATEINACTIVE INGREDIENT4550K0SC9BDUREZOL EMULSION [PHYSICIANS TOTAL CARE, INC.]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IDUREZOL EMULSION [PHYSICIANS TOTAL CARE, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RDUREZOL EMULSION [PHYSICIANS TOTAL CARE, INC.]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
804544difluprednate 0.05 % Ophthalmic EmulsionPSN40ac0711-e2c3-4753-ac58-cb99f558f2931
804544difluprednate 0.5 MG/ML Ophthalmic SuspensionSCD40ac0711-e2c3-4753-ac58-cb99f558f2931
804544difluprednate 0.05 % Ophthalmic EmulsionSY40ac0711-e2c3-4753-ac58-cb99f558f2931

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0065-9240-07000659240071 BOTTLE in 1 CARTON (0065-9240-07) > 5 mL in 1 BOTTLE1 bottle2013-05-150000-00-00NoNoCurrent
0065-9240-08000659240081 BOTTLE in 1 CARTON (0065-9240-08) > 1 mL in 1 BOTTLE1 bottle2013-05-150000-00-00NoNoCurrent