Diclofenac Sodium

Product NDC
60429-421
11-digit product format
604290421
Labeler code
60429
Product ID
60429-421_3997d1b8-499c-cb56-e063-6294a90a9250
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA074514
Marketing category
ANDA
Marketing start
1996-03-26
Marketing end
2027-04-30
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Diclofenac Sodium

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DICLOFENAC SODIUM50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQTG126297Q
Rxcui855906, 855926

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
60429-421-01Diclofenac Sodium100 in 1 BOTTLETABLET, DELAYED RELEASE1009
60429-421-10Diclofenac Sodium1000 in 1 BOTTLETABLET, DELAYED RELEASE10009
60429-421-18Diclofenac Sodium180 in 1 BOTTLETABLET, DELAYED RELEASE1809

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60429-421-01EA - Each60429-421bfefb527-65b6-4e5e-b919-c3fefa8bc90812016-01-13
60429-421-10EA - Each60429-421c385d410-b3aa-4843-aca2-837792fbeab812016-01-13
60429-421-18EA - Each60429-42184782438-ffff-442e-ad59-0ad17ca038b312016-01-13
60429-421-60EA - Each60429-421952a6b94-eee3-4d3f-be45-374b60033e6612016-01-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60429-421DICLOFENAC SODIUM TABLET, DELAYED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]8Current NDC, Legacy NDC, 3 package rows20230504_c1d87003-f54b-4381-9e11-1c39ea2d9eb3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855906diclofenac sodium 50 MG Delayed Release Oral TabletPSNc1d87003-f54b-4381-9e11-1c39ea2d9eb310
855926diclofenac sodium 75 MG Delayed Release Oral TabletPSNc1d87003-f54b-4381-9e11-1c39ea2d9eb310
855906diclofenac sodium 50 MG Delayed Release Oral TabletSCDc1d87003-f54b-4381-9e11-1c39ea2d9eb310
855926diclofenac sodium 75 MG Delayed Release Oral TabletSCDc1d87003-f54b-4381-9e11-1c39ea2d9eb310
855906diclofenac sodium 50 MG Delayed Release Oral TabletPSNe4af374a-1281-46af-a0a9-48820db6c9471
855906diclofenac sodium 50 MG Delayed Release Oral TabletSCDe4af374a-1281-46af-a0a9-48820db6c9471

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60429-421-0160429042101100 TABLET, DELAYED RELEASE in 1 BOTTLE (60429-421-01) 2015-07-270000-00-00NoNoCurrent
60429-421-10604290421101000 TABLET, DELAYED RELEASE in 1 BOTTLE (60429-421-10) 2015-07-270000-00-00NoNoCurrent
60429-421-1860429042118180 TABLET, DELAYED RELEASE in 1 BOTTLE (60429-421-18) 2015-07-270000-00-00NoNoCurrent