FDA.reportPublic FDA data

Diclofenac Sodium

Product NDC
68788-8784
11-digit product format
687888784
Labeler code
68788
Product ID
68788-8784_d4e5f932-8371-496b-b551-c70a9ca76bda
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA090066
Marketing category
ANDA
Marketing start
2024-12-12
Substance
DICLOFENAC SODIUM
Active strength
50 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 SODIUM50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQTG126297Q
Rxcui855906

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
68788-8784-1Diclofenac Sodium100 in 1 BOTTLETABLET, DELAYED RELEASE1002
68788-8784-3Diclofenac Sodium30 in 1 BOTTLETABLET, DELAYED RELEASE302
68788-8784-6Diclofenac Sodium60 in 1 BOTTLETABLET, DELAYED RELEASE602
68788-8784-8Diclofenac Sodium120 in 1 BOTTLETABLET, DELAYED RELEASE1202
68788-8784-9Diclofenac Sodium90 in 1 BOTTLETABLET, DELAYED RELEASE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8784-1EA - Each68788-8784e16f9b4f-3f86-4582-8568-33760bdcd2b812025-02-10
68788-8784-3EA - Each68788-87847cfd55a6-e7ae-4db5-802a-c5768970a01312025-02-10
68788-8784-6EA - Each68788-8784603f7961-acf1-49ec-aedb-f21f1283217712025-02-10
68788-8784-8EA - Each68788-8784eaca9fba-e893-4bc1-950f-8753b2ecaecf12025-02-10
68788-8784-9EA - Each68788-878465136704-a1c8-4881-b5f0-0001ff63532d12025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8784DICLOFENAC SODIUM TABLET, DELAYED RELEASE [PREFERRED PHARMACEUTICALS INC.]1Current NDC, 5 package rows20241215_4ee64a93-9965-47c8-be2c-14232df44b2b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855906diclofenac sodium 50 MG Delayed Release Oral TabletPSN4ee64a93-9965-47c8-be2c-14232df44b2b2
855906diclofenac sodium 50 MG Delayed Release Oral TabletSCD4ee64a93-9965-47c8-be2c-14232df44b2b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68788-8784-168788878401100 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-8784-1) 2024-12-12NoNoHistorical
68788-8784-36878887840330 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-8784-3) 2024-12-12NoNoHistorical
68788-8784-66878887840660 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-8784-6) 2024-12-12NoNoHistorical
68788-8784-868788878408120 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-8784-8) 2024-12-12NoNoHistorical
68788-8784-96878887840990 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-8784-9) 2024-12-12NoNoHistorical