Diclofenac Potassium

Product NDC
55700-989
11-digit product format
557000989
Labeler code
55700
Product ID
55700-989_e74fb2a4-3d18-4d89-8591-fe5b5e5e8b9c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diclofenac potassium
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Quality Care Products, LLC
Application
ANDA075229
Marketing category
ANDA
Marketing start
2022-11-22
Marketing end
2026-06-30
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Diclofenac Potassium

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
55700-989-60Diclofenac Potassium60 in 1 BOTTLETABLET, COATED604

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55700-989-60EA - Each55700-98919ab7c12-f26a-4820-a711-aa4a35502a2212022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55700-989DICLOFENAC POTASSIUM TABLET, COATED [QUALITY CARE PRODUCTS, LLC]4Current NDC, Legacy NDC, 1 package rows20241222_da98a208-e2b0-429e-b405-fa7ecca65dc6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855942diclofenac potassium 50 MG Oral TabletPSNda98a208-e2b0-429e-b405-fa7ecca65dc64
855942diclofenac potassium 50 MG Oral TabletSCDda98a208-e2b0-429e-b405-fa7ecca65dc64
855942Diclofenac K+ 50 MG Oral TabletSYda98a208-e2b0-429e-b405-fa7ecca65dc64
855942Diclofenac Pot 50 MG Oral TabletSYda98a208-e2b0-429e-b405-fa7ecca65dc64

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55700-989-605570009896060 TABLET, COATED in 1 BOTTLE (55700-989-60) 2022-11-222026-06-30NoNoCurrent