FDA.reportPublic FDA data

Diclofenac Sodium

Product NDC
71335-2543
11-digit product format
713352543
Labeler code
71335
Product ID
71335-2543_a080cd82-7866-49c6-91a9-722e38dba3a4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA090066
Marketing category
ANDA
Marketing start
2010-12-31
Substance
DICLOFENAC SODIUM
Active strength
50 mg/1
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 SODIUM50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQTG126297Q
Rxcui855906

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-2543-1Diclofenac Sodium30 in 1 BOTTLETABLET, DELAYED RELEASE302
71335-2543-2Diclofenac Sodium60 in 1 BOTTLETABLET, DELAYED RELEASE602
71335-2543-3Diclofenac Sodium90 in 1 BOTTLETABLET, DELAYED RELEASE902
71335-2543-4Diclofenac Sodium120 in 1 BOTTLETABLET, DELAYED RELEASE1202
71335-2543-5Diclofenac Sodium20 in 1 BOTTLETABLET, DELAYED RELEASE202
71335-2543-6Diclofenac Sodium1000 in 1 BOTTLETABLET, DELAYED RELEASE10002
71335-2543-7Diclofenac Sodium14 in 1 BOTTLETABLET, DELAYED RELEASE142

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2543DICLOFENAC SODIUM TABLET, DELAYED RELEASE [BRYANT RANCH PREPACK]2Current NDC, 7 package rows20250212_af480e78-ff65-4709-af26-c430aefb77d6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855906diclofenac sodium 50 MG Delayed Release Oral TabletPSNaf480e78-ff65-4709-af26-c430aefb77d62
855906diclofenac sodium 50 MG Delayed Release Oral TabletSCDaf480e78-ff65-4709-af26-c430aefb77d62

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-2543-17133525430130 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2543-1) 2025-01-08NoNoHistorical
71335-2543-27133525430260 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2543-2) 2025-01-08NoNoHistorical
71335-2543-37133525430390 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2543-3) 2025-01-08NoNoHistorical
71335-2543-471335254304120 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2543-4) 2025-01-08NoNoHistorical
71335-2543-57133525430520 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2543-5) 2025-01-08NoNoHistorical
71335-2543-6713352543061000 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2543-6) 2025-01-08NoNoHistorical
71335-2543-77133525430714 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2543-7) 2025-01-08NoNoHistorical