Diclofenac Sodium

Product NDC
71205-995
11-digit product format
712050995
Labeler code
71205
Product ID
71205-995_38aee69e-e66f-42b1-814a-551742b1a9cd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA075185
Marketing category
ANDA
Marketing start
1998-11-13
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Diclofenac Sodium
Brand name suffix
Delayed Release
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DICLOFENAC SODIUM50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQTG126297Q
Rxcui855906, 855926

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
71205-995-00Diclofenac SodiumDelayed Release100 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE1004
71205-995-11Diclofenac SodiumDelayed Release1000 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE10004
71205-995-30Diclofenac SodiumDelayed Release30 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE304
71205-995-60Diclofenac SodiumDelayed Release60 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE604
71205-995-72Diclofenac SodiumDelayed Release120 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE1204
71205-995-78Diclofenac SodiumDelayed Release180 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE1804
71205-995-90Diclofenac SodiumDelayed Release90 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-995DICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [PROFICIENT RX LP]4Current NDC, Legacy NDC, 7 package rows20220716_afce2de2-0c59-4191-bf79-782ca31e427d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855906diclofenac sodium 50 MG Delayed Release Oral TabletPSNafce2de2-0c59-4191-bf79-782ca31e427d4
855926diclofenac sodium 75 MG Delayed Release Oral TabletPSNafce2de2-0c59-4191-bf79-782ca31e427d4
855906diclofenac sodium 50 MG Delayed Release Oral TabletSCDafce2de2-0c59-4191-bf79-782ca31e427d4
855926diclofenac sodium 75 MG Delayed Release Oral TabletSCDafce2de2-0c59-4191-bf79-782ca31e427d4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-995-0071205099500100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (71205-995-00) 2020-04-010000-00-00NoNoCurrent
71205-995-11712050995111000 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (71205-995-11) 2020-04-010000-00-00NoNoCurrent
71205-995-307120509953030 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (71205-995-30) 2020-04-010000-00-00NoNoCurrent
71205-995-607120509956060 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (71205-995-60) 2020-04-010000-00-00NoNoCurrent
71205-995-7271205099572120 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (71205-995-72) 2020-04-010000-00-00NoNoCurrent
71205-995-7871205099578180 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (71205-995-78) 2020-04-010000-00-00NoNoCurrent
71205-995-907120509959090 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (71205-995-90) 2020-04-010000-00-00NoNoCurrent