FDA.reportPublic FDA data

Diclofenac Sodium

Product NDC
50090-3316
11-digit product format
500903316
Labeler code
50090
Product ID
50090-3316_49ad4cc4-ab83-4966-b18b-20b43b9120e8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac
Dosage form
SOLUTION
Route
TOPICAL
Labeler
A-S Medication Solutions
Application
ANDA206116
Marketing category
ANDA
Marketing start
2016-09-02
Substance
DICLOFENAC SODIUM
Active strength
16.05 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 SODIUM16.05 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQTG126297Q
Rxcui857700

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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
50090-3316-02023-02-07C16284748780-19d75b9d0-8eff-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use DICLOFENAC SODIUM TOPICAL SOLUTION safely and effectively. See full prescribing information for DICLOFENAC SODIUM TOPICAL SOLUTION. DICLOFENAC SODIUM topical solution 1.5% w/w, for topical use Initial U.S. Approval: 1988
50090-3316-02023-01-30C16284748780-19d75b9d0-8eff-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use DICLOFENAC SODIUM TOPICAL SOLUTION safely and effectively. See full prescribing information for DICLOFENAC SODIUM TOPICAL SOLUTION. DICLOFENAC SODIUM topical solution 1.5% w/w, for topical use Initial U.S. Approval: 1988
50090-3316-02020-10-13C16284748780-19d75b9d0-8eff-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use DICLOFENAC SODIUM TOPICAL SOLUTION safely and effectively. See full prescribing information for DICLOFENAC SODIUM TOPICAL SOLUTION. DICLOFENAC SODIUM topical solution 1.5% w/w, for topical use Initial U.S. Approval: 1988
50090-3316-02020-01-31C16284748780-19d75b9d0-8eff-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use DICLOFENAC SODIUM TOPICAL SOLUTION safely and effectively. See full prescribing information for DICLOFENAC SODIUM TOPICAL SOLUTION. DICLOFENAC SODIUM topical solution 1.5% w/w, for topical use Initial U.S. Approval: 1988

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3316-0Diclofenac Sodium1 in 1 CARTONSOLUTION112
50090-3316-0Diclofenac Sodium150 mL in 1 BOTTLESOLUTION15012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3316-0ML - Milliliter50090-33169640173e-2346-413b-addd-17b35259bcf712019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3316DICLOFENAC SODIUM (DICLOFENAC) SOLUTION [A-S MEDICATION SOLUTIONS]12Current NDC, Legacy NDC, 2 package rows20230511_58178f0d-3960-48e3-91ba-150f691be241.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857700diclofenac sodium 1.5 % Topical SolutionPSN58178f0d-3960-48e3-91ba-150f691be24112
857700diclofenac sodium 15 MG/ML Topical SolutionSCD58178f0d-3960-48e3-91ba-150f691be24112
857700diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical SolutionSY58178f0d-3960-48e3-91ba-150f691be24112
857700diclofenac sodium 16.05 MG per 1 ML Topical SolutionSY58178f0d-3960-48e3-91ba-150f691be24112

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-3316-0500903316001 BOTTLE in 1 CARTON (50090-3316-0) / 150 mL in 1 BOTTLE1 bottle2017-12-280000-00-00NoNoCurrent