FDA.reportPublic FDA data

DICLOFENAC SODIUM

Product NDC
72888-150
11-digit product format
728880150
Labeler code
72888
Product ID
72888-150_34008387-2a5c-a02a-e063-6394a90a4c40
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DICLOFENAC SODIUM
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
Advagen Pharma Ltd
Application
ANDA077600
Marketing category
ANDA
Marketing start
2025-04-30
Substance
DICLOFENAC SODIUM
Active strength
1 mg/mL
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DICLOFENAC SODIUM1 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQTG126297Q
Rxcui854801

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814
111d457e-3138-4512-b0ba-d0cd760c4055Product name320250225
0426261e-1bb9-b78b-abd2-80da765a7e3eProduct name220240513
7b6158ae-c3f4-3d73-c35f-6f5d18b9efd7Product name520240320
0ac2f11f-f58d-baf2-71a0-680993b48a61Product name220231211
855d63c3-b090-4636-8fc7-6d39ad23c44fProduct name120230829
bb58f410-04be-65dd-9211-e89ead899698Product name620230323
0fcbc38a-8b29-3348-1cef-5222ea53484fProduct name420220516
c4e1eedc-aca2-4551-8382-89144ed9d049Product name320220126
8d368a34-1453-43ea-828d-0dbcd72b8794Product name820210622
d6bab9d2-edce-a213-4796-226ab15472c3Product name620200616
2487e6ef-d419-42fc-aaf8-7acc805d2370Product name220170718
e071c814-e5e7-e7ed-ec76-428765d9c66bProduct name220151120
93148e06-b8d7-4e6c-853e-62f807d17fbbProduct name120151014
dbb00be6-fb1c-4b0a-a770-31f7e05e247eProduct name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72888-150-21DICLOFENAC SODIUM2.5 mL in 1 BOTTLESOLUTION2.53
72888-150-21DICLOFENAC SODIUM1 in 1 CARTONSOLUTION13
72888-150-22DICLOFENAC SODIUM5 mL in 1 BOTTLESOLUTION53
72888-150-22DICLOFENAC SODIUM1 in 1 CARTONSOLUTION13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72888-150-21ML - Milliliter72888-1504f7c8f90-b3b6-45bf-b4c5-f13fed71a26612025-06-13
72888-150-22ML - Milliliter72888-150407a89b3-05f5-454f-9cfd-6cdfa833653f12025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72888-150DICLOFENAC SODIUM SOLUTION [ADVAGEN PHARMA LTD]3Current NDC, 4 package rows20250501_72419a68-4c9d-44e0-9b43-922440e2c8d7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854801diclofenac sodium 0.1 % Ophthalmic SolutionPSN72419a68-4c9d-44e0-9b43-922440e2c8d73
854801diclofenac sodium 1 MG/ML Ophthalmic SolutionSCD72419a68-4c9d-44e0-9b43-922440e2c8d73
854801diclofenac sodium 0.1 % Ophthalmic SolutionSY72419a68-4c9d-44e0-9b43-922440e2c8d73

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72888-150-21728880150211 BOTTLE in 1 CARTON (72888-150-21) / 2.5 mL in 1 BOTTLE1 bottle2025-04-30NoNoCurrent
72888-150-22728880150221 BOTTLE in 1 CARTON (72888-150-22) / 5 mL in 1 BOTTLE1 bottle2025-04-30NoNoCurrent