FDA.reportPublic FDA data

Diclofenac Sodium

Product NDC
50090-7838
11-digit product format
500907838
Labeler code
50090
Product ID
50090-7838_8a5992ce-44cc-460a-970e-4d7b5ac068e5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA075185
Marketing category
ANDA
Marketing start
2025-03-28
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
Rxcui855926

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
50090-7838-0Diclofenac SodiumDelayed Release100 in 1 BOTTLETABLET, DELAYED RELEASE1001
50090-7838-1Diclofenac SodiumDelayed Release20 in 1 BOTTLETABLET, DELAYED RELEASE201
50090-7838-2Diclofenac SodiumDelayed Release30 in 1 BOTTLETABLET, DELAYED RELEASE301
50090-7838-3Diclofenac SodiumDelayed Release14 in 1 BOTTLETABLET, DELAYED RELEASE141
50090-7838-4Diclofenac SodiumDelayed Release60 in 1 BOTTLETABLET, DELAYED RELEASE601
50090-7838-8Diclofenac SodiumDelayed Release90 in 1 BOTTLETABLET, DELAYED RELEASE901
50090-7838-9Diclofenac SodiumDelayed Release180 in 1 BOTTLETABLET, DELAYED RELEASE1801

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7838-0EA - Each50090-7838aef16f2d-bbbb-4a0d-bc69-6dce4553c14612026-02-05
50090-7838-1EA - Each50090-7838b98a8d35-5c9a-4507-9119-5d256649294912026-02-05
50090-7838-2EA - Each50090-7838df863402-c6dd-4be5-b809-2e4902606aae12026-02-05
50090-7838-3EA - Each50090-7838886e5325-e885-4287-affc-d16bb456ff2b12026-02-05
50090-7838-4EA - Each50090-78381ae0264b-d010-432e-a253-3b8058a817a412026-02-05
50090-7838-8EA - Each50090-78380f17b2b8-41d1-4a12-bd40-a8c73bd09e5212026-02-05
50090-7838-9EA - Each50090-7838e5546fdc-6a7d-48de-a85f-f5e31e901d9b12026-02-05

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855926diclofenac sodium 75 MG Delayed Release Oral TabletPSN40388047-7fbe-49bf-bed8-e5087bed4e031
855926diclofenac sodium 75 MG Delayed Release Oral TabletSCD40388047-7fbe-49bf-bed8-e5087bed4e031

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-7838-050090783800100 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-7838-0) 2025-12-29NoNoCurrent
50090-7838-15009078380120 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-7838-1) 2025-12-29NoNoCurrent
50090-7838-25009078380230 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-7838-2) 2025-12-29NoNoCurrent
50090-7838-35009078380314 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-7838-3) 2025-12-29NoNoCurrent
50090-7838-45009078380460 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-7838-4) 2025-12-29NoNoCurrent
50090-7838-85009078380890 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-7838-8) 2025-12-29NoNoCurrent
50090-7838-950090783809180 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-7838-9) 2025-12-29NoNoCurrent