FDA.reportPublic FDA data

Diclofenac Sodium

Product NDC
61442-102
11-digit product format
614420102
Labeler code
61442
Product ID
61442-102_350d8fde-4096-17eb-e063-6394a90a9984
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Carlsbad Technology, Inc.
Application
ANDA075185
Marketing category
ANDA
Marketing start
1998-11-13
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
Brand name suffix
Delayed Release
Listing expiration
2026-12-31

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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
61442-102-01Diclofenac SodiumDelayed Release100 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE10013
61442-102-01Diclofenac SodiumDelayed Release24 in 1 BOXTABLET, DELAYED RELEASE2413
61442-102-10Diclofenac SodiumDelayed Release1000 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE100013
61442-102-10Diclofenac SodiumDelayed Release12 in 1 BOXTABLET, DELAYED RELEASE1213
61442-102-60Diclofenac SodiumDelayed Release60 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE6013
61442-102-60Diclofenac SodiumDelayed Release24 in 1 BOXTABLET, DELAYED RELEASE2413

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61442-102DICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE DICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [CARLSBAD TECHNOLOGY, INC.]12Current NDC, Legacy NDC, 6 package rows20240809_40879600-ba6c-43a8-aa5d-d0d41503d593.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855906diclofenac sodium 50 MG Delayed Release Oral TabletPSN2bebda5e-227e-4a49-80e3-191cfc805295106
855906diclofenac sodium 50 MG Delayed Release Oral TabletSCD2bebda5e-227e-4a49-80e3-191cfc805295106
855906diclofenac sodium 50 MG Delayed Release Oral TabletPSN12cce748-a7de-4b1e-9603-b5c2ce12d531104
855906diclofenac sodium 50 MG Delayed Release Oral TabletSCD12cce748-a7de-4b1e-9603-b5c2ce12d531104
855906diclofenac sodium 50 MG Delayed Release Oral TabletPSN2b7462e6-62dc-4b08-9fbf-5858e356a7a8103
855906diclofenac sodium 50 MG Delayed Release Oral TabletSCD2b7462e6-62dc-4b08-9fbf-5858e356a7a8103
855906diclofenac sodium 50 MG Delayed Release Oral TabletPSN70156824-e5dd-42b1-9b4f-a49acb28d31643
855926diclofenac sodium 75 MG Delayed Release Oral TabletPSN70156824-e5dd-42b1-9b4f-a49acb28d31643
855906diclofenac sodium 50 MG Delayed Release Oral TabletSCD70156824-e5dd-42b1-9b4f-a49acb28d31643
855926diclofenac sodium 75 MG Delayed Release Oral TabletSCD70156824-e5dd-42b1-9b4f-a49acb28d31643
855906diclofenac sodium 50 MG Delayed Release Oral TabletPSN9df87100-acf5-4b46-93b4-067b470136bd19
855906diclofenac sodium 50 MG Delayed Release Oral TabletSCD9df87100-acf5-4b46-93b4-067b470136bd19
855906diclofenac sodium 50 MG Delayed Release Oral TabletPSNae0add8e-3a8a-4c5d-af3b-907f64211fef18
855906diclofenac sodium 50 MG Delayed Release Oral TabletSCDae0add8e-3a8a-4c5d-af3b-907f64211fef18
855906diclofenac sodium 50 MG Delayed Release Oral TabletPSN19b4ff5c-adb7-a0d0-7ef2-4ae05047fd9417
855926diclofenac sodium 75 MG Delayed Release Oral TabletPSN19b4ff5c-adb7-a0d0-7ef2-4ae05047fd9417
855906diclofenac sodium 50 MG Delayed Release Oral TabletSCD19b4ff5c-adb7-a0d0-7ef2-4ae05047fd9417
855926diclofenac sodium 75 MG Delayed Release Oral TabletSCD19b4ff5c-adb7-a0d0-7ef2-4ae05047fd9417
855906diclofenac sodium 50 MG Delayed Release Oral TabletPSN40879600-ba6c-43a8-aa5d-d0d41503d59313
855906diclofenac sodium 50 MG Delayed Release Oral TabletPSNe947653c-6789-4c15-82c9-4b1402f6d6ac13
855926diclofenac sodium 75 MG Delayed Release Oral TabletPSN40879600-ba6c-43a8-aa5d-d0d41503d59313
855906diclofenac sodium 50 MG Delayed Release Oral TabletSCDe947653c-6789-4c15-82c9-4b1402f6d6ac13
855906diclofenac sodium 50 MG Delayed Release Oral TabletSCD40879600-ba6c-43a8-aa5d-d0d41503d59313
855926diclofenac sodium 75 MG Delayed Release Oral TabletSCD40879600-ba6c-43a8-aa5d-d0d41503d59313
855906diclofenac sodium 50 MG Delayed Release Oral TabletPSNddd2278b-70be-41ca-8a84-e3fe0f1a156112
855906diclofenac sodium 50 MG Delayed Release Oral TabletPSN2ae3c1e2-f053-4efb-9597-eeac4998d23f12
855926diclofenac sodium 75 MG Delayed Release Oral TabletPSN2ae3c1e2-f053-4efb-9597-eeac4998d23f12
855906diclofenac sodium 50 MG Delayed Release Oral TabletSCDddd2278b-70be-41ca-8a84-e3fe0f1a156112
855906diclofenac sodium 50 MG Delayed Release Oral TabletSCD2ae3c1e2-f053-4efb-9597-eeac4998d23f12
855926diclofenac sodium 75 MG Delayed Release Oral TabletSCD2ae3c1e2-f053-4efb-9597-eeac4998d23f12
855906diclofenac sodium 50 MG Delayed Release Oral TabletPSN14c1b1a1-bc06-4722-9612-e88ae52272bc10
855906diclofenac sodium 50 MG Delayed Release Oral TabletSCD14c1b1a1-bc06-4722-9612-e88ae52272bc10
855906diclofenac sodium 50 MG Delayed Release Oral TabletPSN89ccfc76-245f-4604-bc1d-9115c657c3407
855926diclofenac sodium 75 MG Delayed Release Oral TabletPSN89ccfc76-245f-4604-bc1d-9115c657c3407
855906diclofenac sodium 50 MG Delayed Release Oral TabletSCD89ccfc76-245f-4604-bc1d-9115c657c3407
855926diclofenac sodium 75 MG Delayed Release Oral TabletSCD89ccfc76-245f-4604-bc1d-9115c657c3407
855906diclofenac sodium 50 MG Delayed Release Oral TabletPSNec06cca5-3436-10c8-e053-2995a90a4aeb6
855906diclofenac sodium 50 MG Delayed Release Oral TabletSCDec06cca5-3436-10c8-e053-2995a90a4aeb6
855906diclofenac sodium 50 MG Delayed Release Oral TabletPSN629b77cf-f825-8640-e053-2991aa0a10a85
855906diclofenac sodium 50 MG Delayed Release Oral TabletPSN51cc1a22-6386-4d8e-847e-30568ba84db35
855906diclofenac sodium 50 MG Delayed Release Oral TabletPSNb2d71822-a7f3-447c-911c-971a21af53465
855926diclofenac sodium 75 MG Delayed Release Oral TabletPSNb2d71822-a7f3-447c-911c-971a21af53465
855906diclofenac sodium 50 MG Delayed Release Oral TabletSCD629b77cf-f825-8640-e053-2991aa0a10a85
855906diclofenac sodium 50 MG Delayed Release Oral TabletSCD51cc1a22-6386-4d8e-847e-30568ba84db35
855906diclofenac sodium 50 MG Delayed Release Oral TabletSCDb2d71822-a7f3-447c-911c-971a21af53465
855926diclofenac sodium 75 MG Delayed Release Oral TabletSCDb2d71822-a7f3-447c-911c-971a21af53465
855906diclofenac sodium 50 MG Delayed Release Oral TabletPSNafce2de2-0c59-4191-bf79-782ca31e427d4
855906diclofenac sodium 50 MG Delayed Release Oral TabletPSNf2b7ea75-738b-54a8-e053-2995a90a00d54
855906diclofenac sodium 50 MG Delayed Release Oral TabletPSN4b44ac98-225c-1739-e054-00144ff88e884
855926diclofenac sodium 75 MG Delayed Release Oral TabletPSNafce2de2-0c59-4191-bf79-782ca31e427d4
855906diclofenac sodium 50 MG Delayed Release Oral TabletSCDafce2de2-0c59-4191-bf79-782ca31e427d4
855906diclofenac sodium 50 MG Delayed Release Oral TabletSCD4b44ac98-225c-1739-e054-00144ff88e884
855906diclofenac sodium 50 MG Delayed Release Oral TabletSCDf2b7ea75-738b-54a8-e053-2995a90a00d54
855926diclofenac sodium 75 MG Delayed Release Oral TabletSCDafce2de2-0c59-4191-bf79-782ca31e427d4
855906diclofenac sodium 50 MG Delayed Release Oral TabletPSNafed223d-cedd-f100-e053-2a95a90ade122
855906diclofenac sodium 50 MG Delayed Release Oral TabletPSN947c0c1f-3573-4f69-ab82-8b50c43e55862
855906diclofenac sodium 50 MG Delayed Release Oral TabletPSN09d0fb5b-60c2-bd7b-e063-6394a90a3be52
855906diclofenac sodium 50 MG Delayed Release Oral TabletSCD09d0fb5b-60c2-bd7b-e063-6394a90a3be52
855906diclofenac sodium 50 MG Delayed Release Oral TabletSCD947c0c1f-3573-4f69-ab82-8b50c43e55862
855906diclofenac sodium 50 MG Delayed Release Oral TabletSCDafed223d-cedd-f100-e053-2a95a90ade122
855906diclofenac sodium 50 MG Delayed Release Oral TabletPSN47a7a294-55bb-8d19-e063-6394a90a54401
855906diclofenac sodium 50 MG Delayed Release Oral TabletPSN39e67a90-df3e-ad30-e063-6394a90a7a821
855906diclofenac sodium 50 MG Delayed Release Oral TabletPSNcc715a60-32e0-4d31-a1df-2a591a56d4e51
855906diclofenac sodium 50 MG Delayed Release Oral TabletPSN9af3a740-ef82-26ce-e053-2a95a90a0ee11
855926diclofenac sodium 75 MG Delayed Release Oral TabletPSN39e67a90-df3e-ad30-e063-6394a90a7a821
855906diclofenac sodium 50 MG Delayed Release Oral TabletSCD47a7a294-55bb-8d19-e063-6394a90a54401
855906diclofenac sodium 50 MG Delayed Release Oral TabletSCD39e67a90-df3e-ad30-e063-6394a90a7a821
855906diclofenac sodium 50 MG Delayed Release Oral TabletSCDcc715a60-32e0-4d31-a1df-2a591a56d4e51
855906diclofenac sodium 50 MG Delayed Release Oral TabletSCD9af3a740-ef82-26ce-e053-2a95a90a0ee11
855926diclofenac sodium 75 MG Delayed Release Oral TabletSCD39e67a90-df3e-ad30-e063-6394a90a7a821

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61442-102-016144201020124 BOTTLE, PLASTIC in 1 BOX (61442-102-01) / 100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC1998-11-130000-00-00NoNoCurrent
61442-102-106144201021012 BOTTLE, PLASTIC in 1 BOX (61442-102-10) / 1000 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC1998-11-130000-00-00NoNoCurrent
61442-102-606144201026024 BOTTLE, PLASTIC in 1 BOX (61442-102-60) / 60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC1998-11-130000-00-00NoNoCurrent