FDA.reportPublic FDA data

Diclofenac Sodium

Product NDC
60290-084
11-digit product format
602900084
Labeler code
60290
Product ID
60290-084_499a6352-e243-abaf-e063-6394a90a8ae4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Umedica Laboratories USA Inc.
Application
ANDA219945
Marketing category
ANDA
Marketing start
2026-02-15
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
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 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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
60290-084-01Diclofenac Sodium60 in 1 BOTTLETABLET, DELAYED RELEASE606
60290-084-02Diclofenac Sodium100 in 1 BOTTLETABLET, DELAYED RELEASE1006
60290-084-03Diclofenac Sodium500 in 1 BOTTLETABLET, DELAYED RELEASE5006
60290-084-04Diclofenac Sodium1000 in 1 BOTTLETABLET, DELAYED RELEASE10006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60290-084-01EA - Each60290-0841ff0e415-cac9-4a74-99bf-ade6ae44ef8d12026-05-22
60290-084-02EA - Each60290-0848b468ee6-d302-4d14-b6b7-410db63f1d0912026-05-22

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855664diclofenac sodium 25 MG Delayed Release Oral TabletPSN0e5c6669-390f-4c32-b9b8-13ed3c5174626
855906diclofenac sodium 50 MG Delayed Release Oral TabletPSN0e5c6669-390f-4c32-b9b8-13ed3c5174626
855926diclofenac sodium 75 MG Delayed Release Oral TabletPSN0e5c6669-390f-4c32-b9b8-13ed3c5174626
855664diclofenac sodium 25 MG Delayed Release Oral TabletSCD0e5c6669-390f-4c32-b9b8-13ed3c5174626
855906diclofenac sodium 50 MG Delayed Release Oral TabletSCD0e5c6669-390f-4c32-b9b8-13ed3c5174626
855926diclofenac sodium 75 MG Delayed Release Oral TabletSCD0e5c6669-390f-4c32-b9b8-13ed3c5174626

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
60290-084-016029000840160 TABLET, DELAYED RELEASE in 1 BOTTLE (60290-084-01) 2026-02-15NoNoCurrent
60290-084-0260290008402100 TABLET, DELAYED RELEASE in 1 BOTTLE (60290-084-02) 2026-02-15NoNoCurrent
60290-084-0360290008403500 TABLET, DELAYED RELEASE in 1 BOTTLE (60290-084-03) 2026-02-15NoNoCurrent
60290-084-04602900084041000 TABLET, DELAYED RELEASE in 1 BOTTLE (60290-084-04) 2026-02-15NoNoCurrent