FDA.reportPublic FDA data

Diclofenac Potassium

Product NDC
85509-1900
11-digit product format
855091900
Labeler code
85509
Product ID
85509-1900_4838cc6f-de90-bc42-e063-6394a90a2b9f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diclofenac potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PHOENIX RX LLC
Application
ANDA215787
Marketing category
ANDA
Marketing start
2024-11-01
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
85509-1900-1Diclofenac Potassium100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1002
85509-1900-3Diclofenac Potassium30 in 1 BOTTLE, PLASTICTABLET, FILM COATED302
85509-1900-6Diclofenac Potassium60 in 1 BOTTLE, PLASTICTABLET, FILM COATED602
85509-1900-9Diclofenac Potassium90 in 1 BOTTLE, PLASTICTABLET, FILM COATED902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
85509-1900-1EA - Each85509-19004526bb3d-6b9d-4e8b-9e61-51e8f55dcb1f12026-02-05
85509-1900-3EA - Each85509-19008818391d-766d-4f49-a5bc-27805f1e77d112026-02-05
85509-1900-6EA - Each85509-1900c22a22c8-10e3-404c-a8e9-f2824b0c3c0b12026-02-05
85509-1900-9EA - Each85509-1900bd72a123-4c3f-4ea2-b9d1-2081c5dd232012026-02-05

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855942diclofenac potassium 50 MG Oral TabletPSN43448b74-6c02-a581-e063-6394a90a63ba2
855942diclofenac potassium 50 MG Oral TabletSCD43448b74-6c02-a581-e063-6394a90a63ba2
855942Diclofenac K+ 50 MG Oral TabletSY43448b74-6c02-a581-e063-6394a90a63ba2
855942Diclofenac Pot 50 MG Oral TabletSY43448b74-6c02-a581-e063-6394a90a63ba2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
85509-1900-185509190001100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (85509-1900-1) 2026-01-12NoNoHistorical
85509-1900-38550919000330 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (85509-1900-3) 2025-11-07NoNoHistorical
85509-1900-68550919000660 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (85509-1900-6) 2026-01-12NoNoHistorical
85509-1900-98550919000990 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (85509-1900-9) 2026-01-12NoNoHistorical