FDA.reportPublic FDA data

DICLOFENAC SODIUM

Product NDC
50090-7855
11-digit product format
500907855
Labeler code
50090
Product ID
50090-7855_7cd367ac-9d03-4db9-9c8e-1d8dc26aee35
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DICLOFENAC SODIUM
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA075281
Marketing category
ANDA
Marketing start
2025-04-17
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
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
50090-7855-0DICLOFENAC SODIUM100 in 1 BOTTLETABLET, DELAYED RELEASE1001
50090-7855-1DICLOFENAC SODIUM20 in 1 BOTTLETABLET, DELAYED RELEASE201
50090-7855-2DICLOFENAC SODIUM30 in 1 BOTTLETABLET, DELAYED RELEASE301
50090-7855-3DICLOFENAC SODIUM14 in 1 BOTTLETABLET, DELAYED RELEASE141
50090-7855-4DICLOFENAC SODIUM60 in 1 BOTTLETABLET, DELAYED RELEASE601
50090-7855-8DICLOFENAC SODIUM90 in 1 BOTTLETABLET, DELAYED RELEASE901
50090-7855-9DICLOFENAC SODIUM180 in 1 BOTTLETABLET, DELAYED RELEASE1801

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7855-0EA - Each50090-78554b4bfc14-3299-433a-a838-4dd1015d074612026-02-05
50090-7855-1EA - Each50090-7855911459d4-d251-4b22-b120-a0690db3734012026-02-05
50090-7855-2EA - Each50090-785534235b0e-c88d-480a-aadf-f1db18cbec7f12026-02-05
50090-7855-3EA - Each50090-7855f8249f51-a697-47dd-aa8e-d5ae1f36d97512026-02-05
50090-7855-4EA - Each50090-78558c4db7f0-2cc0-4659-bab4-1b8bd9979b7812026-02-05
50090-7855-8EA - Each50090-7855bc216f61-f0bc-4268-8331-3dba701442de12026-02-05
50090-7855-9EA - Each50090-78555e809301-3d6c-4445-b25a-d20dddcc10ec12026-02-05

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855926diclofenac sodium 75 MG Delayed Release Oral TabletPSN6c57e330-ebbe-4165-84a8-4844b2f0097e1
855926diclofenac sodium 75 MG Delayed Release Oral TabletSCD6c57e330-ebbe-4165-84a8-4844b2f0097e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-7855-050090785500100 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-7855-0) 2026-01-14NoNoHistorical
50090-7855-15009078550120 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-7855-1) 2026-01-14NoNoHistorical
50090-7855-25009078550230 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-7855-2) 2026-01-14NoNoHistorical
50090-7855-35009078550314 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-7855-3) 2026-01-14NoNoHistorical
50090-7855-45009078550460 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-7855-4) 2026-01-14NoNoHistorical
50090-7855-85009078550890 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-7855-8) 2026-01-14NoNoHistorical
50090-7855-950090785509180 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-7855-9) 2026-01-14NoNoHistorical