FDA.reportPublic FDA data

Diclofenac Sodium 1.5%

Product NDC
50436-3338
11-digit product format
504363338
Labeler code
50436
Product ID
50436-3338_09544567-99d6-4d06-bc89-6929746157ee
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Sodium Topical
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Unit Dose Services
Application
ANDA204132
Marketing category
ANDA
Marketing start
2021-06-04
Marketing end
0000-00-00
Substance
DICLOFENAC SODIUM
Active strength
16 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
2023-12-31
Current FDA listing
Historical FDA.report record

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
50436-3338-12024-01-30C16284748780-11030e365-6c94-111a-e063-dadaa90a10e2HIGHLIGHTS OF PRESCRIBING INFORMATION These 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. Initial U.S. Approval: 1988

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-3338-1Diclofenac Sodium 1.5%150 mL in 1 BOTTLESOLUTION1502

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50436-3338-1ML - Milliliter50436-33387adc5efb-0fb8-4fd4-9bdf-bccebdfc19db12022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-3338DICLOFENAC SODIUM 1.5% (DICLOFENAC SODIUM TOPICAL) SOLUTION [UNIT DOSE SERVICES]2Legacy NDC, 1 package rows20220121_1f12948a-a52b-4a71-b555-edd98cc5a373.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857700diclofenac sodium 1.5 % Topical SolutionPSN1f12948a-a52b-4a71-b555-edd98cc5a3732
857700diclofenac sodium 15 MG/ML Topical SolutionSCD1f12948a-a52b-4a71-b555-edd98cc5a3732
857700diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical SolutionSY1f12948a-a52b-4a71-b555-edd98cc5a3732
857700diclofenac sodium 16.05 MG per 1 ML Topical SolutionSY1f12948a-a52b-4a71-b555-edd98cc5a3732

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50436-3338-150436333801150 mL in 1 BOTTLE (50436-3338-1) 150 ml2021-12-150000-00-00NoNoCurrent