Diclofenac Sodium

Product NDC
50383-528
11-digit product format
503830528
Labeler code
50383
Product ID
50383-528_0b7b1230-d848-4795-be3b-387d26eb2932
Type
HUMAN OTC DRUG
Nonproprietary name
Diclofenac Sodium
Dosage form
GEL
Route
TOPICAL
Labeler
Akorn
Application
ANDA209484
Marketing category
ANDA
Marketing start
2021-12-31
Marketing end
0000-00-00
Substance
DICLOFENAC SODIUM
Active strength
10 mg/g
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50383-528-012025-09-10C16284748780-11030e365-42e1-111a-e063-dadaa90a10e20b7b1230-d848-4795-be3b-387d26eb2932
50383-528-012024-01-30C16284748780-11030e365-42e1-111a-e063-dadaa90a10e20b7b1230-d848-4795-be3b-387d26eb2932

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50383-528DICLOFENAC SODIUM GEL [AKORN]2Legacy NDC20220427_0b7b1230-d848-4795-be3b-387d26eb2932.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50383-528-01503830528011 TUBE in 1 CARTON (50383-528-01) > 100 g in 1 TUBE1 tube2021-12-310000-00-00NoNoCurrent