FDA.reportPublic FDA data

Diclofenac Sodium

Product NDC
49884-935
11-digit product format
498840935
Labeler code
49884
Product ID
49884-935_5573200b-bb6a-4197-9f5d-bff47f824ddb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diclofenac sodium
Dosage form
GEL
Route
TOPICAL
Labeler
Par Pharmaceutical Inc
Application
NDA022122
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2016-07-01
Marketing end
0000-00-00
Substance
DICLOFENAC SODIUM
Active strength
10 mg/g
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
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
49884-935-472021-07-23C16284748780-1c7ccaba7-0f09-fd44-e053-dadaa90aa01bThese highlights do not include all the information needed to use DICLOFENAC SODIUM TOPICAL GEL safely and effectively. See full prescribing information for DICLOFENAC SODIUM TOPICAL GEL. DICLOFENAC SODIUM TOPICAL GEL 1%, for topical use only Initial U.S. Approval: 1988

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49884-935-47Diclofenac Sodium1 in 1 CARTONGEL16
49884-935-47Diclofenac Sodium100 g in 1 TUBEGEL1006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49884-935DICLOFENAC SODIUM GEL [PAR PHARMACEUTICAL INC]6Legacy NDC, 2 package rows20200312_d240f348-8a14-4f62-9815-a760f02b4f4f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855633diclofenac sodium 1 % Topical GelPSN721fceb7-25c6-43bc-85a7-58ac4a525d3b7
855633diclofenac sodium 0.01 MG/MG Topical GelSCD721fceb7-25c6-43bc-85a7-58ac4a525d3b7
855633diclofenac sodium 1 % Topical GelSY721fceb7-25c6-43bc-85a7-58ac4a525d3b7
855633diclofenac sodium 1 % Topical GelPSNd240f348-8a14-4f62-9815-a760f02b4f4f6
855633diclofenac sodium 0.01 MG/MG Topical GelSCDd240f348-8a14-4f62-9815-a760f02b4f4f6
855633diclofenac sodium 1 % Topical GelSYd240f348-8a14-4f62-9815-a760f02b4f4f6
855633diclofenac sodium 1 % Topical GelPSNa7447467-79e0-436e-a273-d1ddd06169cf3
855633diclofenac sodium 0.01 MG/MG Topical GelSCDa7447467-79e0-436e-a273-d1ddd06169cf3
855633diclofenac sodium 1 % Topical GelSYa7447467-79e0-436e-a273-d1ddd06169cf3
855633diclofenac sodium 1 % Topical GelPSN5c264f39-d23f-4bfb-9b67-fb7b005bbb441
855633diclofenac sodium 0.01 MG/MG Topical GelSCD5c264f39-d23f-4bfb-9b67-fb7b005bbb441
855633diclofenac sodium 1 % Topical GelSY5c264f39-d23f-4bfb-9b67-fb7b005bbb441

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49884-935-47498840935471 TUBE in 1 CARTON (49884-935-47) > 100 g in 1 TUBE1 tube2016-07-012022-11-30NoNoCurrent