FDA.reportPublic FDA data

Diclofenac Potassium

Product NDC
66267-070
11-digit product format
662670070
Labeler code
66267
Product ID
66267-070_1f98d6d5-cf08-a2bf-e063-6294a90a370b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare 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

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66267-070-302024-08-13C16284748780-1f386c64a-0bb1-0266-e053-dadaa90a7c1aDICLOFENAC POTASSIUM TABLETS USP, 50 mg 0948 Rx only
66267-070-602024-08-13C16284748780-1f386c64a-0bb1-0266-e053-dadaa90a7c1aDICLOFENAC POTASSIUM TABLETS USP, 50 mg 0948 Rx only
66267-070-302023-01-30C16284748780-1f386c64a-0bb1-0266-e053-dadaa90a7c1aDICLOFENAC POTASSIUM TABLETS USP, 50 mg 0948 Rx only
66267-070-602023-01-30C16284748780-1f386c64a-0bb1-0266-e053-dadaa90a7c1aDICLOFENAC POTASSIUM TABLETS USP, 50 mg 0948 Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66267-070-30Diclofenac Potassium30 in 1 BOTTLETABLET, FILM COATED304
66267-070-60Diclofenac Potassium60 in 1 BOTTLETABLET, FILM COATED604

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66267-070-30EA - Each66267-0705e2b6314-86a1-40b4-8891-66c9cd85ac2e12016-10-06
66267-070-60EA - Each66267-070de2b2d34-3059-4c17-8aa8-7d4aa21293c912016-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66267-070DICLOFENAC POTASSIUM TABLET, FILM COATED [NUCARE PHARMACEUTICALS, INC.]4Current NDC, Legacy NDC, 2 package rows20240815_3da9e463-1b2f-54c0-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855942diclofenac potassium 50 MG Oral TabletPSN3da9e463-1b2f-54c0-e054-00144ff88e884
855942diclofenac potassium 50 MG Oral TabletSCD3da9e463-1b2f-54c0-e054-00144ff88e884
855942Diclofenac K+ 50 MG Oral TabletSY3da9e463-1b2f-54c0-e054-00144ff88e884
855942Diclofenac Pot 50 MG Oral TabletSY3da9e463-1b2f-54c0-e054-00144ff88e884

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
66267-070-306626700703030 TABLET, FILM COATED in 1 BOTTLE (66267-070-30) 2016-09-290000-00-00NoNoCurrent
66267-070-606626700706060 TABLET, FILM COATED in 1 BOTTLE (66267-070-60) 2016-09-290000-00-00NoNoCurrent