FDA.reportPublic FDA data

Diclofenac Sodium

Product NDC
53002-4642
11-digit product format
530024642
Labeler code
53002
Product ID
53002-4642_1fb9f1ec-711f-47f5-8138-1d762e6c8255
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Sodium Topical Gel, 1%,
Dosage form
GEL
Route
TOPICAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA210986
Marketing category
ANDA
Marketing start
2020-01-30
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

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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
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
53002-4642-12025-01-30C16284748780-12cef2736-904a-d83d-e063-dadaa90ab31fThese 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
53002-4642-1Diclofenac Sodium100 g in 1 TUBEGEL1001
53002-4642-1Diclofenac Sodium1 in 1 CARTONGEL11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-4642DICLOFENAC SODIUM (DICLOFENAC SODIUM TOPICAL GEL, 1%,) GEL [RPK PHARMACEUTICALS, INC.]1Legacy NDC, 2 package rows20220331_1f21022e-7d86-438f-a49e-0a787f499cc4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855633diclofenac sodium 1 % Topical GelPSN1f21022e-7d86-438f-a49e-0a787f499cc41
855633diclofenac sodium 0.01 MG/MG Topical GelSCD1f21022e-7d86-438f-a49e-0a787f499cc41
855633diclofenac sodium 1 % Topical GelSY1f21022e-7d86-438f-a49e-0a787f499cc41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-4642-1530024642011 TUBE in 1 CARTON (53002-4642-1) > 100 g in 1 TUBE1 tube2021-01-010000-00-00NoNoCurrent