FDA.reportPublic FDA data

DICLOFENAC SODIUM

Product NDC
68071-3516
11-digit product format
680713516
Labeler code
68071
Product ID
68071-3516_4af5a0b8-d72d-cca7-e063-6294a90a1b7f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diclofenac sodium
Dosage form
GEL
Route
TOPICAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA208301
Marketing category
ANDA
Marketing start
2016-09-13
Substance
DICLOFENAC SODIUM
Active strength
30 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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
DICLOFENAC SODIUM
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DICLOFENAC SODIUM30 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQTG126297Q
Rxcui855642

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
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-3516-12025-02-01C16284748780-12cef2736-9070-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use DICLOFENAC SODIUM GEL safely and effectively. See full prescribing information for DICLOFENAC SODIUM GEL. DICLOFENAC SODIUM topical gel Initial U.S. Approval: 2000

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-3516-1DICLOFENAC SODIUM1 in 1 CARTONGEL13
68071-3516-1DICLOFENAC SODIUM100 g in 1 TUBEGEL1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3516DICLOFENAC SODIUM GEL [NUCARE PHARMACEUTICALS,INC.]2Current NDC, 2 package rows20250202_06862cf2-9537-6661-e063-6294a90a2084.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855642diclofenac sodium 3 % Topical GelPSN06862cf2-9537-6661-e063-6294a90a20843
855642diclofenac sodium 0.03 MG/MG Topical GelSCD06862cf2-9537-6661-e063-6294a90a20843
855642diclofenac sodium 3 % Topical GelSY06862cf2-9537-6661-e063-6294a90a20843

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68071-3516-1680713516011 TUBE in 1 CARTON (68071-3516-1) / 100 g in 1 TUBE1 tube2023-09-29NoNoHistorical