FDA.reportPublic FDA data

Diclofenac Potassium

Product NDC
70518-3538
11-digit product format
705183538
Labeler code
70518
Product ID
70518-3538_4f570f56-0e12-4aa6-e063-6394a90a0f3c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diclofenac potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA215585
Marketing category
ANDA
Marketing start
2022-09-26
Substance
DICLOFENAC POTASSIUM
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 Potassium
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DICLOFENAC POTASSIUM50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL4D5UA6CB4
Rxcui855942

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
70518-3538-0Diclofenac Potassium60 in 1 BOTTLE, PLASTICTABLET, FILM COATED609
70518-3538-1Diclofenac Potassium30 in 1 BOTTLE, PLASTICTABLET, FILM COATED309
70518-3538-2Diclofenac Potassium270 in 1 BOTTLE, PLASTICTABLET, FILM COATED2709
70518-3538-3Diclofenac Potassium90 in 1 BOTTLE, PLASTICTABLET, FILM COATED909

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3538DICLOFENAC POTASSIUM TABLET, FILM COATED [REMEDYREPACK INC.]6Current NDC, Legacy NDC, 4 package rows20241011_c4976d69-ca06-4263-9240-6fd8b44a9b6d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855942diclofenac potassium 50 MG Oral TabletPSNc4976d69-ca06-4263-9240-6fd8b44a9b6d9
855942diclofenac potassium 50 MG Oral TabletSCDc4976d69-ca06-4263-9240-6fd8b44a9b6d9
855942Diclofenac K+ 50 MG Oral TabletSYc4976d69-ca06-4263-9240-6fd8b44a9b6d9
855942Diclofenac Pot 50 MG Oral TabletSYc4976d69-ca06-4263-9240-6fd8b44a9b6d9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-3538-07051835380060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3538-0) 2022-09-260000-00-00NoNoCurrent
70518-3538-17051835380130 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3538-1) 2022-12-190000-00-00NoNoCurrent
70518-3538-270518353802270 in 1 BOTTLE, PLASTICHistorical
70518-3538-37051835380390 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3538-3) 2023-04-06NoNoCurrent