Diclofenac Potassium

Product NDC
50090-6768
11-digit product format
500906768
Labeler code
50090
Product ID
50090-6768_fe1e72df-f70a-4e79-8ebf-10f3a9983961
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Potassium Tablets
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA215750
Marketing category
ANDA
Marketing start
2022-05-12
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Diclofenac Potassium
Listing expiration
2026-12-31

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
50090-6768-0Diclofenac Potassium30 in 1 BOTTLETABLET, FILM COATED301
50090-6768-1Diclofenac Potassium21 in 1 BOTTLETABLET, FILM COATED211
50090-6768-4Diclofenac Potassium90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6768-0EA - Each50090-6768c7186ab3-7c06-4801-884a-6cfeaa37d3c512023-12-05
50090-6768-1EA - Each50090-67683c0af913-23d0-463a-8967-00f1d72f17dd12023-12-05
50090-6768-4EA - Each50090-676871cff38e-616e-434c-9804-173977f4ac7712023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6768DICLOFENAC POTASSIUM (DICLOFENAC POTASSIUM TABLETS) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]1Current NDC, 3 package rows20231027_5d37fc5a-7a2f-432e-b4e9-e00c246ce33c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855942diclofenac potassium 50 MG Oral TabletPSN5d37fc5a-7a2f-432e-b4e9-e00c246ce33c1
855942diclofenac potassium 50 MG Oral TabletSCD5d37fc5a-7a2f-432e-b4e9-e00c246ce33c1
855942Diclofenac K+ 50 MG Oral TabletSY5d37fc5a-7a2f-432e-b4e9-e00c246ce33c1
855942Diclofenac Pot 50 MG Oral TabletSY5d37fc5a-7a2f-432e-b4e9-e00c246ce33c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-6768-05009067680030 TABLET, FILM COATED in 1 BOTTLE (50090-6768-0) 2023-10-23NoNoCurrent
50090-6768-15009067680121 TABLET, FILM COATED in 1 BOTTLE (50090-6768-1) 2023-10-23NoNoCurrent
50090-6768-45009067680490 TABLET, FILM COATED in 1 BOTTLE (50090-6768-4) 2023-10-23NoNoCurrent