FDA.reportPublic FDA data

Diclofenac Sodium

Product NDC
71335-2684
11-digit product format
713352684
Labeler code
71335
Product ID
71335-2684_a18f3fb9-d435-4b8f-9081-22d615fe35eb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA216548
Marketing category
ANDA
Marketing start
2023-05-11
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
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
71335-2684-0Diclofenac Sodium40 in 1 BOTTLETABLET, DELAYED RELEASE401
71335-2684-1Diclofenac Sodium28 in 1 BOTTLETABLET, DELAYED RELEASE281
71335-2684-2Diclofenac Sodium60 in 1 BOTTLETABLET, DELAYED RELEASE601
71335-2684-3Diclofenac Sodium20 in 1 BOTTLETABLET, DELAYED RELEASE201
71335-2684-4Diclofenac Sodium30 in 1 BOTTLETABLET, DELAYED RELEASE301
71335-2684-5Diclofenac Sodium120 in 1 BOTTLETABLET, DELAYED RELEASE1201
71335-2684-6Diclofenac Sodium90 in 1 BOTTLETABLET, DELAYED RELEASE901
71335-2684-7Diclofenac Sodium100 in 1 BOTTLETABLET, DELAYED RELEASE1001
71335-2684-8Diclofenac Sodium15 in 1 BOTTLETABLET, DELAYED RELEASE151
71335-2684-9Diclofenac Sodium14 in 1 BOTTLETABLET, DELAYED RELEASE141

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2684-2EA - Each71335-268434fbe769-33f8-48ea-80d3-984d00bc086c12026-03-17
71335-2684-4EA - Each71335-26847e9a2149-4120-4c6d-a922-3ede3f74aa9812026-03-17

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855926diclofenac sodium 75 MG Delayed Release Oral TabletPSN03c4f06f-6a49-4404-bf3b-0aafa33c81ef1
855926diclofenac sodium 75 MG Delayed Release Oral TabletSCD03c4f06f-6a49-4404-bf3b-0aafa33c81ef1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-2684-07133526840040 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2684-0) 2026-02-13NoNoHistorical
71335-2684-17133526840128 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2684-1) 2026-02-13NoNoHistorical
71335-2684-27133526840260 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2684-2) 2026-02-13NoNoHistorical
71335-2684-37133526840320 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2684-3) 2026-02-13NoNoHistorical
71335-2684-47133526840430 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2684-4) 2026-02-13NoNoHistorical
71335-2684-571335268405120 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2684-5) 2026-02-13NoNoHistorical
71335-2684-67133526840690 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2684-6) 2026-02-13NoNoHistorical
71335-2684-771335268407100 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2684-7) 2026-02-13NoNoHistorical
71335-2684-87133526840815 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2684-8) 2026-02-13NoNoHistorical
71335-2684-97133526840914 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2684-9) 2026-02-13NoNoHistorical