FDA.reportPublic FDA data

Diclofenac Potassium

Product NDC
43063-848
11-digit product format
430630848
Labeler code
43063
Product ID
43063-848_2fc3b270-b101-5a08-e063-6394a90a7fd2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA075219
Marketing category
ANDA
Marketing start
1998-08-11
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
351abe41-466c-4dd8-840a-0fdb68318bd5Product name120230316
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
43063-848-21Diclofenac Potassium21 in 1 BOTTLE, PLASTICTABLET, FILM COATED2116
43063-848-30Diclofenac Potassium30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-848-21EA - Each43063-848bbdc260a-47e6-400c-9a75-d6154e832fc812018-05-09
43063-848-30EA - Each43063-8482fa843b0-9bbd-4f60-8f65-b62eec61794912018-05-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-848DICLOFENAC POTASSIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]16Current NDC, Legacy NDC, 2 package rows20250309_08e41a9d-644c-4ac6-aba3-38d7c3f36d36.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855942diclofenac potassium 50 MG Oral TabletPSN08e41a9d-644c-4ac6-aba3-38d7c3f36d3616
855942diclofenac potassium 50 MG Oral TabletSCD08e41a9d-644c-4ac6-aba3-38d7c3f36d3616
855942Diclofenac K+ 50 MG Oral TabletSY08e41a9d-644c-4ac6-aba3-38d7c3f36d3616
855942Diclofenac Pot 50 MG Oral TabletSY08e41a9d-644c-4ac6-aba3-38d7c3f36d3616

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43063-848-214306308482121 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-848-21) 2018-04-120000-00-00NoNoCurrent
43063-848-304306308483030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-848-30) 2018-04-120000-00-00NoNoCurrent