DIFLUPREDNATE

Product NDC
69097-341
11-digit product format
690970341
Labeler code
69097
Product ID
69097-341_825a55a7-ffdf-4fde-bbb2-486cbd16e602
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DIFLUPREDNATE
Dosage form
EMULSION
Route
OPHTHALMIC
Labeler
Cipla USA Inc.
Application
ANDA211776
Marketing category
ANDA
Marketing start
2021-08-09
Substance
DIFLUPREDNATE
Active strength
.5 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
DIFLUPREDNATE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIFLUPREDNATE.5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiS8A06QG2QE
Rxcui804544

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69097-341-35DIFLUPREDNATE1 in 1 CARTONEMULSION11
69097-341-35DIFLUPREDNATE5 mL in 1 BOTTLEEMULSION51

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69097-341-35ML - Milliliter69097-341da3feb29-51a2-4ec1-8f42-197c8c174fad12021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69097-341DIFLUPREDNATE EMULSION [CIPLA USA INC.]1Current NDC, Legacy NDC, 2 package rows20210814_8a7254de-a7a2-476d-9295-c41926267ec9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
804544difluprednate 0.05 % Ophthalmic EmulsionPSN8a7254de-a7a2-476d-9295-c41926267ec91
804544difluprednate 0.5 MG/ML Ophthalmic SuspensionSCD8a7254de-a7a2-476d-9295-c41926267ec91
804544difluprednate 0.05 % Ophthalmic EmulsionSY8a7254de-a7a2-476d-9295-c41926267ec91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69097-341-35690970341351 BOTTLE in 1 CARTON (69097-341-35) / 5 mL in 1 BOTTLE1 bottle2021-08-090000-00-00NoNoCurrent