FDA.reportPublic FDA data

Diclofenac Potassium

Product NDC
70512-750
11-digit product format
705120750
Labeler code
70512
Product ID
70512-750_47d44b29-dfd3-eace-e063-6394a90a4d24
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diclofenac potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
SOLA Pharmaceuticals, LLC
Application
ANDA215787
Marketing category
ANDA
Marketing start
2024-10-21
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
70512-750-10Diclofenac Potassium100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1005
70512-750-50Diclofenac Potassium500 in 1 BOTTLE, PLASTICTABLET, FILM COATED5005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70512-750-10EA - Each70512-750a01faf9d-4144-46ce-9a69-90145912e3d912024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70512-750DICLOFENAC POTASSIUM TABLET, FILM COATED [SOLA PHARMACEUTICALS, LLC]4Current NDC, 2 package rows20241027_e770efc8-bbad-4103-98e4-e31019a540f5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855942diclofenac potassium 50 MG Oral TabletPSNe770efc8-bbad-4103-98e4-e31019a540f55
855942diclofenac potassium 50 MG Oral TabletSCDe770efc8-bbad-4103-98e4-e31019a540f55
855942Diclofenac K+ 50 MG Oral TabletSYe770efc8-bbad-4103-98e4-e31019a540f55
855942Diclofenac Pot 50 MG Oral TabletSYe770efc8-bbad-4103-98e4-e31019a540f55
855942diclofenac potassium 50 MG Oral TabletPSN3fd418ac-49f6-d520-e063-6394a90afbd83
855942diclofenac potassium 50 MG Oral TabletSCD3fd418ac-49f6-d520-e063-6394a90afbd83
855942Diclofenac K+ 50 MG Oral TabletSY3fd418ac-49f6-d520-e063-6394a90afbd83
855942Diclofenac Pot 50 MG Oral TabletSY3fd418ac-49f6-d520-e063-6394a90afbd83
855942diclofenac potassium 50 MG Oral TabletPSN295d5dab-8890-d76e-e063-6394a90ad4021
855942diclofenac potassium 50 MG Oral TabletPSN6394ab5f-b3ff-4397-97eb-ff92485c5ec01
855942diclofenac potassium 50 MG Oral TabletSCD295d5dab-8890-d76e-e063-6394a90ad4021
855942diclofenac potassium 50 MG Oral TabletSCD6394ab5f-b3ff-4397-97eb-ff92485c5ec01
855942Diclofenac K+ 50 MG Oral TabletSY295d5dab-8890-d76e-e063-6394a90ad4021
855942Diclofenac K+ 50 MG Oral TabletSY6394ab5f-b3ff-4397-97eb-ff92485c5ec01
855942Diclofenac Pot 50 MG Oral TabletSY295d5dab-8890-d76e-e063-6394a90ad4021
855942Diclofenac Pot 50 MG Oral TabletSY6394ab5f-b3ff-4397-97eb-ff92485c5ec01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70512-750-1070512075010100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70512-750-10) 2024-10-21NoNoCurrent
70512-750-5070512075050500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70512-750-50) 2024-12-31NoNoCurrent