Diclofenac Sodium

Product NDC
70518-2707
11-digit product format
705182707
Labeler code
70518
Product ID
70518-2707_4e3ece60-9bee-235f-e063-6394a90abcf7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA075185
Marketing category
ANDA
Marketing start
2020-04-23
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
Brand name suffix
Delayed Release
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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-2707-0Diclofenac SodiumDelayed Release90 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE9012
70518-2707-1Diclofenac SodiumDelayed Release60 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE6012
70518-2707-2Diclofenac SodiumDelayed Release60 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE6012
70518-2707-3Diclofenac SodiumDelayed Release30 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE3012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70518-2707-2EA - Each70518-2707cd78da41-89b9-4e97-b529-a842f9d86d4512026-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2707DICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [REMEDYREPACK INC.]8Current NDC, Legacy NDC, 4 package rows20250330_ddd2278b-70be-41ca-8a84-e3fe0f1a1561.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855906diclofenac sodium 50 MG Delayed Release Oral TabletPSNddd2278b-70be-41ca-8a84-e3fe0f1a156112
855906diclofenac sodium 50 MG Delayed Release Oral TabletSCDddd2278b-70be-41ca-8a84-e3fe0f1a156112

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-2707-07051827070090 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (70518-2707-0) 2020-04-230000-00-00NoNoCurrent
70518-2707-17051827070160 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (70518-2707-1) 2020-12-220000-00-00NoNoCurrent
70518-2707-27051827070260 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (70518-2707-2) 2021-10-200000-00-00NoNoCurrent
70518-2707-37051827070330 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (70518-2707-3) 2025-08-11NoNoHistorical