FDA.reportPublic FDA data

Diclofenac Sodium

Product NDC
61442-226
11-digit product format
614420226
Labeler code
61442
Product ID
61442-226_363745c4-873f-ad20-e063-6394a90a8a84
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
2025-03-28
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
Rxcui855664, 855906, 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
61442-226-01Diclofenac SodiumDelayed Release100 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE1001
61442-226-01Diclofenac SodiumDelayed Release24 in 1 BOXTABLET, DELAYED RELEASE241
61442-226-10Diclofenac SodiumDelayed Release12 in 1 BOXTABLET, DELAYED RELEASE121
61442-226-10Diclofenac SodiumDelayed Release1000 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE10001
61442-226-60Diclofenac SodiumDelayed Release24 in 1 BOXTABLET, DELAYED RELEASE241
61442-226-60Diclofenac SodiumDelayed Release60 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61442-226-01EA - Each61442-22628bc0d88-f389-426f-83f4-0f7dfb58d14212025-10-14
61442-226-10EA - Each61442-2269b6ee97b-ed98-4981-8936-6187ebe759e112025-10-14
61442-226-60EA - Each61442-226d2605526-cb87-4471-a981-b227dcbe083f12025-10-14

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855664diclofenac sodium 25 MG Delayed Release Oral TabletPSN468fab22-2b69-4a2c-e063-6294a90aab9a2
855906diclofenac sodium 50 MG Delayed Release Oral TabletPSN468fab22-2b69-4a2c-e063-6294a90aab9a2
855926diclofenac sodium 75 MG Delayed Release Oral TabletPSN468fab22-2b69-4a2c-e063-6294a90aab9a2
855664diclofenac sodium 25 MG Delayed Release Oral TabletSCD468fab22-2b69-4a2c-e063-6294a90aab9a2
855906diclofenac sodium 50 MG Delayed Release Oral TabletSCD468fab22-2b69-4a2c-e063-6294a90aab9a2
855926diclofenac sodium 75 MG Delayed Release Oral TabletSCD468fab22-2b69-4a2c-e063-6294a90aab9a2
855664diclofenac sodium 25 MG Delayed Release Oral TabletPSN363764a0-e0a8-3e3f-e063-6294a90ad6721
855906diclofenac sodium 50 MG Delayed Release Oral TabletPSN0cefb675-c54e-44eb-b35c-38354b77eddd1
855906diclofenac sodium 50 MG Delayed Release Oral TabletPSN74011b00-7e2e-40a7-ab30-c05a205598141
855906diclofenac sodium 50 MG Delayed Release Oral TabletPSN50886f90-8cd0-4d38-e063-6294a90a44e41
855906diclofenac sodium 50 MG Delayed Release Oral TabletPSN363764a0-e0a8-3e3f-e063-6294a90ad6721
855926diclofenac sodium 75 MG Delayed Release Oral TabletPSN363764a0-e0a8-3e3f-e063-6294a90ad6721
855664diclofenac sodium 25 MG Delayed Release Oral TabletSCD363764a0-e0a8-3e3f-e063-6294a90ad6721
855906diclofenac sodium 50 MG Delayed Release Oral TabletSCD363764a0-e0a8-3e3f-e063-6294a90ad6721
855906diclofenac sodium 50 MG Delayed Release Oral TabletSCD50886f90-8cd0-4d38-e063-6294a90a44e41
855906diclofenac sodium 50 MG Delayed Release Oral TabletSCD0cefb675-c54e-44eb-b35c-38354b77eddd1
855906diclofenac sodium 50 MG Delayed Release Oral TabletSCD74011b00-7e2e-40a7-ab30-c05a205598141
855926diclofenac sodium 75 MG Delayed Release Oral TabletSCD363764a0-e0a8-3e3f-e063-6294a90ad6721

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
61442-226-016144202260124 BOTTLE, PLASTIC in 1 BOX (61442-226-01) / 100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC2025-03-28NoNoCurrent
61442-226-106144202261012 BOTTLE, PLASTIC in 1 BOX (61442-226-10) / 1000 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC2025-03-28NoNoCurrent
61442-226-606144202266024 BOTTLE, PLASTIC in 1 BOX (61442-226-60) / 60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC2025-03-28NoNoCurrent