FDA.reportPublic FDA data

Diclofenac Sodium

Product NDC
50090-2454
11-digit product format
500902454
Labeler code
50090
Product ID
50090-2454_98e8ede7-aa2f-4dfa-90de-b7a9c5b828b4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Sodium
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
A-S Medication Solutions
Application
ANDA078792
Marketing category
ANDA
Marketing start
2007-12-28
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-2454-02025-02-07C16284748780-19d75b9cf-d244-f424-e053-dadaa90a57ceDiclofenac Sodium Ophthalmic Solution, 0.1% (Sterile) Rx only
50090-2454-02020-01-31C16284748780-19d75b9cf-d244-f424-e053-dadaa90a57ceDiclofenac Sodium Ophthalmic Solution, 0.1% (Sterile) Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-2454-0Diclofenac Sodium5 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS515
50090-2454-0Diclofenac Sodium1 in 1 CARTONSOLUTION/ DROPS115

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2454-0ML - Milliliter50090-2454a853ec8a-8313-45d2-bf1b-4de24934297d12024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2454DICLOFENAC SODIUM SOLUTION/ DROPS [A-S MEDICATION SOLUTIONS]15Current NDC, Legacy NDC, 2 package rows20250210_5d74488c-e092-415d-b19b-05318380d9b1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854801diclofenac sodium 0.1 % Ophthalmic SolutionPSN5d74488c-e092-415d-b19b-05318380d9b115
854801diclofenac sodium 1 MG/ML Ophthalmic SolutionSCD5d74488c-e092-415d-b19b-05318380d9b115
854801diclofenac sodium 0.1 % Ophthalmic SolutionSY5d74488c-e092-415d-b19b-05318380d9b115

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-2454-0500902454001 BOTTLE, DROPPER in 1 CARTON (50090-2454-0) / 5 mL in 1 BOTTLE, DROPPER2016-08-12NoNoHistorical