FDA.reportPublic FDA data

Diclofenac Sodium

Product NDC
50090-7646
11-digit product format
500907646
Labeler code
50090
Product ID
50090-7646_ebbf814a-dc1d-47eb-9156-bdf4f1dc1100
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
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
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
50090-7646-0Diclofenac Sodium100 in 1 BOTTLETABLET, DELAYED RELEASE1003
50090-7646-1Diclofenac Sodium20 in 1 BOTTLETABLET, DELAYED RELEASE203
50090-7646-2Diclofenac Sodium30 in 1 BOTTLETABLET, DELAYED RELEASE303
50090-7646-3Diclofenac Sodium14 in 1 BOTTLETABLET, DELAYED RELEASE143
50090-7646-4Diclofenac Sodium60 in 1 BOTTLETABLET, DELAYED RELEASE603
50090-7646-8Diclofenac Sodium90 in 1 BOTTLETABLET, DELAYED RELEASE903
50090-7646-9Diclofenac Sodium180 in 1 BOTTLETABLET, DELAYED RELEASE1803

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7646-0EA - Each50090-7646b8b6c801-6cab-4754-8a51-9e0eecf709be12025-10-14
50090-7646-1EA - Each50090-7646507eb77c-000d-4959-a54f-9575b01a7ed112025-10-14
50090-7646-2EA - Each50090-76465b60573a-033c-4646-914d-ee88f62c25fc12025-10-14
50090-7646-3EA - Each50090-764605da96dd-1f58-443a-9755-3d78469ec3ed12025-10-14
50090-7646-4EA - Each50090-7646e4991120-21e6-46b6-94ea-a5390bfe55ef12025-10-14
50090-7646-8EA - Each50090-7646b7eff32e-659b-44d4-a7ea-e6bc75efc7ef12025-10-14
50090-7646-9EA - Each50090-76469313a4e2-3fc5-4ddd-842e-7b581beb177512025-10-14

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-7646-050090764600100 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-7646-0) 2025-09-03NoNoHistorical
50090-7646-15009076460120 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-7646-1) 2025-09-03NoNoHistorical
50090-7646-25009076460230 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-7646-2) 2025-09-03NoNoHistorical
50090-7646-35009076460314 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-7646-3) 2025-09-03NoNoHistorical
50090-7646-45009076460460 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-7646-4) 2025-09-03NoNoHistorical
50090-7646-85009076460890 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-7646-8) 2025-09-03NoNoHistorical
50090-7646-950090764609180 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-7646-9) 2025-09-03NoNoHistorical