FDA.reportPublic FDA data

Diclofenac Sodium

Product NDC
72603-604
11-digit product format
726030604
Labeler code
72603
Product ID
72603-604_33965722-896c-cca3-e063-6394a90a3c61
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
NorthStar Rx LLC
Application
ANDA216548
Marketing category
ANDA
Marketing start
2025-04-23
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DICLOFENAC SODIUM75 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQTG126297Q
Rxcui855664, 855906, 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
72603-604-01Diclofenac Sodium60 in 1 BOTTLETABLET, DELAYED RELEASE601
72603-604-02Diclofenac Sodium500 in 1 BOTTLETABLET, DELAYED RELEASE5001
72603-604-03Diclofenac Sodium1000 in 1 BOTTLETABLET, DELAYED RELEASE10001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72603-604-01EA - Each72603-604c01a8698-5a24-4970-81a6-2a79b018537d12025-06-13
72603-604-02EA - Each72603-604104c0e2b-e10a-446b-a5ac-f3f1589c962612025-06-13
72603-604-03EA - Each72603-604e66741e5-32bc-4ab8-a24c-0cf725bccb8612025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72603-604DICLOFENAC SODIUM TABLET, DELAYED RELEASE [NORTHSTAR RX LLC]1Current NDC, 3 package rows20250427_c7431496-c0ef-403a-9716-92d942709b3d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855926diclofenac sodium 75 MG Delayed Release Oral TabletPSN337c2253-34c1-4611-88c9-d558507255a23
855926diclofenac sodium 75 MG Delayed Release Oral TabletSCD337c2253-34c1-4611-88c9-d558507255a23
855664diclofenac sodium 25 MG Delayed Release Oral TabletPSNc7431496-c0ef-403a-9716-92d942709b3d1
855906diclofenac sodium 50 MG Delayed Release Oral TabletPSNc7431496-c0ef-403a-9716-92d942709b3d1
855926diclofenac sodium 75 MG Delayed Release Oral TabletPSN4c5b722e-0d1a-48e9-87c8-9b370b8ced461
855926diclofenac sodium 75 MG Delayed Release Oral TabletPSNc7431496-c0ef-403a-9716-92d942709b3d1
855664diclofenac sodium 25 MG Delayed Release Oral TabletSCDc7431496-c0ef-403a-9716-92d942709b3d1
855906diclofenac sodium 50 MG Delayed Release Oral TabletSCDc7431496-c0ef-403a-9716-92d942709b3d1
855926diclofenac sodium 75 MG Delayed Release Oral TabletSCD4c5b722e-0d1a-48e9-87c8-9b370b8ced461
855926diclofenac sodium 75 MG Delayed Release Oral TabletSCDc7431496-c0ef-403a-9716-92d942709b3d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72603-604-017260306040160 TABLET, DELAYED RELEASE in 1 BOTTLE (72603-604-01) 2025-04-23NoNoCurrent
72603-604-0272603060402500 TABLET, DELAYED RELEASE in 1 BOTTLE (72603-604-02) 2025-04-23NoNoCurrent
72603-604-03726030604031000 TABLET, DELAYED RELEASE in 1 BOTTLE (72603-604-03) 2025-04-23NoNoCurrent