Diclofenac Sodium

Product NDC
35356-725
11-digit product format
353560725
Labeler code
35356
Product ID
35356-725_9486cfe7-5e5e-46ef-aec5-80adc6fa3277
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Lake Erie Medical DBA Quality Care Products LLC
Application
ANDA090066
Marketing category
ANDA
Marketing start
2010-12-31
Marketing end
0000-00-00
Substance
DICLOFENAC SODIUM
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
2023-12-31
Current FDA listing
Historical FDA.report record

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
35356-725-30Diclofenac Sodium30 in 1 BOTTLETABLET, DELAYED RELEASE303981
35356-725-60Diclofenac Sodium60 in 1 BOTTLETABLET, DELAYED RELEASE603981
35356-725-90Diclofenac Sodium90 in 1 BOTTLETABLET, DELAYED RELEASE903981

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35356-725DICLOFENAC SODIUM TABLET, DELAYED RELEASE [QUALITY CARE PRODUCTS LLC]3981Legacy NDC, 3 package rows20241213_bfa8cb40-3528-4d41-ae77-444e521e30c0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855906diclofenac sodium 50 MG Delayed Release Oral TabletPSNbfa8cb40-3528-4d41-ae77-444e521e30c03981
855926diclofenac sodium 75 MG Delayed Release Oral TabletPSNbfa8cb40-3528-4d41-ae77-444e521e30c03981
855906diclofenac sodium 50 MG Delayed Release Oral TabletSCDbfa8cb40-3528-4d41-ae77-444e521e30c03981
855926diclofenac sodium 75 MG Delayed Release Oral TabletSCDbfa8cb40-3528-4d41-ae77-444e521e30c03981

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
35356-725-303535607253030 in 1 BOTTLEHistorical
35356-725-603535607256060 TABLET, DELAYED RELEASE in 1 BOTTLE (35356-725-60) 2013-02-070000-00-00NoNoCurrent
35356-725-903535607259090 in 1 BOTTLEHistorical