FDA.reportPublic FDA data

Diclofenac sodium

Product NDC
69238-2053
11-digit product format
692382053
Labeler code
69238
Product ID
69238-2053_a723bc13-8e04-48e5-8427-5cb5e6471e4a
Type
HUMAN OTC DRUG
Nonproprietary name
Diclofenac
Dosage form
GEL
Route
TOPICAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA208077
Marketing category
ANDA
Marketing start
2016-03-21
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Diclofenac sodium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DICLOFENAC SODIUM10 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQTG126297Q
Rxcui855633

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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69238-2053-1Diclofenac sodium100 g in 1 TUBEGEL10022
69238-2053-1Diclofenac sodium1 in 1 CARTONGEL122

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-2053DICLOFENAC SODIUM (DICLOFENAC) GEL [AMNEAL PHARMACEUTICALS NY LLC]22Current NDC, Legacy NDC, 2 package rows20231230_1084e0c3-6d75-4090-84dc-02a18e0299b9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855633diclofenac sodium 1 % Topical GelPSN1084e0c3-6d75-4090-84dc-02a18e0299b922
855633diclofenac sodium 0.01 MG/MG Topical GelSCD1084e0c3-6d75-4090-84dc-02a18e0299b922
855633diclofenac sodium 1 % Topical GelSY1084e0c3-6d75-4090-84dc-02a18e0299b922
855633diclofenac sodium 1 % Topical GelPSN03ddf347-a3a3-4313-87d1-a246c1d4e0b46
855633diclofenac sodium 0.01 MG/MG Topical GelSCD03ddf347-a3a3-4313-87d1-a246c1d4e0b46
855633diclofenac sodium 1 % Topical GelSY03ddf347-a3a3-4313-87d1-a246c1d4e0b46
855633diclofenac sodium 1 % Topical GelPSN98f94aa2-6bc2-4c07-81c8-63b2c262cf393
855633diclofenac sodium 0.01 MG/MG Topical GelSCD98f94aa2-6bc2-4c07-81c8-63b2c262cf393
855633diclofenac sodium 1 % Topical GelSY98f94aa2-6bc2-4c07-81c8-63b2c262cf393

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69238-2053-1692382053011 TUBE in 1 CARTON (69238-2053-1) / 100 g in 1 TUBE1 tube2016-03-210000-00-00NoNoCurrent