Diclofenac Sodium

Product NDC
51407-538
11-digit product format
514070538
Labeler code
51407
Product ID
51407-538_39e67937-b2c7-a024-e063-6394a90a6ae0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA075185
Marketing category
ANDA
Marketing start
1998-11-13
Substance
DICLOFENAC SODIUM
Active strength
75 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
Brand name suffix
Delayed Release
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DICLOFENAC SODIUM75 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQTG126297Q
Rxcui855906, 855926

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
51407-538-01Diclofenac SodiumDelayed Release100 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE1001
51407-538-10Diclofenac SodiumDelayed Release1000 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE10001
51407-538-18Diclofenac SodiumDelayed Release180 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE1801

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51407-538-01EA - Each51407-538371e4e3e-772f-4854-a625-499a7f054d4512025-08-11
51407-538-10EA - Each51407-538fb6210ce-2690-499d-9ef9-a34990f15e9e12025-08-11
51407-538-18EA - Each51407-53847239e75-cb12-4aff-9654-7683b716831612025-08-11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855906diclofenac sodium 50 MG Delayed Release Oral TabletPSN39e67a90-df3e-ad30-e063-6394a90a7a821
855926diclofenac sodium 75 MG Delayed Release Oral TabletPSN39e67a90-df3e-ad30-e063-6394a90a7a821
855906diclofenac sodium 50 MG Delayed Release Oral TabletSCD39e67a90-df3e-ad30-e063-6394a90a7a821
855926diclofenac sodium 75 MG Delayed Release Oral TabletSCD39e67a90-df3e-ad30-e063-6394a90a7a821

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
51407-538-0151407053801100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (51407-538-01) 2025-04-08NoNoCurrent
51407-538-10514070538101000 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (51407-538-10) 2025-04-08NoNoCurrent
51407-538-1851407053818180 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (51407-538-18) 2025-04-08NoNoCurrent