FDA.reportPublic FDA data

Diclofenac Sodium

Product NDC
71335-0456
11-digit product format
713350456
Labeler code
71335
Product ID
71335-0456_824033ce-a50b-4914-b0b9-b0005739555c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA077863
Marketing category
ANDA
Marketing start
2008-08-19
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
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
71335-0456-0Diclofenac Sodium40 in 1 BOTTLETABLET, DELAYED RELEASE405
71335-0456-1Diclofenac Sodium28 in 1 BOTTLETABLET, DELAYED RELEASE285
71335-0456-2Diclofenac Sodium60 in 1 BOTTLETABLET, DELAYED RELEASE605
71335-0456-3Diclofenac Sodium20 in 1 BOTTLETABLET, DELAYED RELEASE205
71335-0456-4Diclofenac Sodium30 in 1 BOTTLETABLET, DELAYED RELEASE305
71335-0456-5Diclofenac Sodium120 in 1 BOTTLETABLET, DELAYED RELEASE1205
71335-0456-6Diclofenac Sodium90 in 1 BOTTLETABLET, DELAYED RELEASE905
71335-0456-7Diclofenac Sodium100 in 1 BOTTLETABLET, DELAYED RELEASE1005
71335-0456-8Diclofenac Sodium15 in 1 BOTTLETABLET, DELAYED RELEASE155
71335-0456-9Diclofenac Sodium14 in 1 BOTTLETABLET, DELAYED RELEASE145

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0456-0EA - Each71335-04568edd1a66-bc54-46d3-9d9d-662f0f0db6aa12018-03-08
71335-0456-1EA - Each71335-045627f9c6c0-3463-4d15-a5b0-88c198ac370912018-03-08
71335-0456-2EA - Each71335-04561ef18911-3049-45f1-99b4-2888c5b2cf3e12018-03-08
71335-0456-3EA - Each71335-0456b1be1f32-7f2c-4a6a-98f9-e4a6665e052212018-03-08
71335-0456-4EA - Each71335-0456ffbe2a00-69d8-4cea-98f5-bb8be0abcbd212018-03-08
71335-0456-5EA - Each71335-04561e493354-7953-4edd-9a6e-9822a8ef0a2512018-03-08
71335-0456-6EA - Each71335-04562b96d76f-ae96-436b-aa7f-8bd545d0072612018-03-08
71335-0456-7EA - Each71335-045643499d56-6e1c-47d1-8113-65176f352b5b12018-03-08
71335-0456-8EA - Each71335-0456b5aaba6e-f5da-42a5-88c3-2991f3492b1412018-03-08
71335-0456-9EA - Each71335-045676557782-b50e-4a75-a64f-aff7e30bb35912018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0456DICLOFENAC SODIUM TABLET, DELAYED RELEASE [BRYANT RANCH PREPACK]5Current NDC, Legacy NDC, 10 package rows20250331_487fa223-f4d9-4ab1-a5af-fb0d93f2bd0e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855926diclofenac sodium 75 MG Delayed Release Oral TabletPSN487fa223-f4d9-4ab1-a5af-fb0d93f2bd0e5
855926diclofenac sodium 75 MG Delayed Release Oral TabletSCD487fa223-f4d9-4ab1-a5af-fb0d93f2bd0e5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-0456-07133504560040 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-0456-0) 2009-08-240000-00-00NoNoCurrent
71335-0456-17133504560128 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-0456-1) 2009-08-240000-00-00NoNoCurrent
71335-0456-27133504560260 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-0456-2) 2009-08-240000-00-00NoNoCurrent
71335-0456-37133504560320 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-0456-3) 2009-08-240000-00-00NoNoCurrent
71335-0456-47133504560430 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-0456-4) 2009-08-240000-00-00NoNoCurrent
71335-0456-571335045605120 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-0456-5) 2009-08-240000-00-00NoNoCurrent
71335-0456-67133504560690 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-0456-6) 2009-08-240000-00-00NoNoCurrent
71335-0456-771335045607100 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-0456-7) 2009-08-240000-00-00NoNoCurrent
71335-0456-87133504560815 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-0456-8) 2009-08-240000-00-00NoNoCurrent
71335-0456-97133504560914 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-0456-9) 2009-08-240000-00-00NoNoCurrent