FDA.reportPublic FDA data

Diclofenac Sodium

Product NDC
61145-101
11-digit product format
611450101
Labeler code
61145
Product ID
61145-101_a6c57ef9-36a1-413e-8266-fed804999cbb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
REPHARM LLC
Application
ANDA075185
Marketing category
ANDA
Marketing start
2017-09-27
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
61145-101-06Diclofenac SodiumDelayed Release24 in 1 BOXTABLET, DELAYED RELEASE245
61145-101-06Diclofenac SodiumDelayed Release60 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE605
61145-101-09Diclofenac SodiumDelayed Release24 in 1 BOXTABLET, DELAYED RELEASE245
61145-101-09Diclofenac SodiumDelayed Release90 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE905
61145-101-18Diclofenac SodiumDelayed Release180 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE1805
61145-101-18Diclofenac SodiumDelayed Release24 in 1 BOXTABLET, DELAYED RELEASE245

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61145-101DICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [REPHARM LLC]3Current NDC, Legacy NDC, 6 package rows20221221_b2d71822-a7f3-447c-911c-971a21af5346.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855906diclofenac sodium 50 MG Delayed Release Oral TabletPSNb2d71822-a7f3-447c-911c-971a21af53465
855926diclofenac sodium 75 MG Delayed Release Oral TabletPSNb2d71822-a7f3-447c-911c-971a21af53465
855906diclofenac sodium 50 MG Delayed Release Oral TabletSCDb2d71822-a7f3-447c-911c-971a21af53465
855926diclofenac sodium 75 MG Delayed Release Oral TabletSCDb2d71822-a7f3-447c-911c-971a21af53465

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61145-101-066114501010624 BOTTLE, PLASTIC in 1 BOX (61145-101-06) / 60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC2017-09-270000-00-00NoNoCurrent
61145-101-096114501010924 BOTTLE, PLASTIC in 1 BOX (61145-101-09) / 90 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC2017-09-270000-00-00NoNoCurrent
61145-101-186114501011824 BOTTLE, PLASTIC in 1 BOX (61145-101-18) / 180 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC2017-09-270000-00-00NoNoCurrent