Diclofenac Sodium

Product NDC
76420-670
11-digit product format
764200670
Labeler code
76420
Product ID
76420-670_4ddafa63-9c36-1918-e063-6394a90a7ddc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Asclemed USA, Inc.
Application
ANDA077863
Marketing category
ANDA
Marketing start
2008-08-19
Substance
DICLOFENAC SODIUM
Active strength
75 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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Diclofenac Sodium
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DICLOFENAC SODIUM75 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
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
76420-670-00Diclofenac Sodium1000 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE10002
76420-670-01Diclofenac Sodium100 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE1002
76420-670-05Diclofenac Sodium500 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE5002
76420-670-30Diclofenac Sodium30 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE302
76420-670-60Diclofenac Sodium60 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE602
76420-670-90Diclofenac Sodium90 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-670-01EA - Each76420-670bef22ad2-c37b-495c-96f0-0065f4c126eb12024-05-16
76420-670-30EA - Each76420-6709026d14e-0ad9-44dd-a128-b3e84526cc1712024-05-16
76420-670-60EA - Each76420-6706dcf07be-38e4-4107-9f44-6f8740f81ccc12024-05-16
76420-670-90EA - Each76420-67043928baf-7228-4ef7-ad1e-ef7affd6739512024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-670DICLOFENAC SODIUM TABLET, DELAYED RELEASE [ASCLEMED USA, INC.]1Current NDC, 6 package rows20240310_2ac9fadc-dc84-4c4a-a12d-dd78ecec93a8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855664diclofenac sodium 25 MG Delayed Release Oral TabletPSN2ac9fadc-dc84-4c4a-a12d-dd78ecec93a82
855906diclofenac sodium 50 MG Delayed Release Oral TabletPSN2ac9fadc-dc84-4c4a-a12d-dd78ecec93a82
855926diclofenac sodium 75 MG Delayed Release Oral TabletPSN2ac9fadc-dc84-4c4a-a12d-dd78ecec93a82
855664diclofenac sodium 25 MG Delayed Release Oral TabletSCD2ac9fadc-dc84-4c4a-a12d-dd78ecec93a82
855906diclofenac sodium 50 MG Delayed Release Oral TabletSCD2ac9fadc-dc84-4c4a-a12d-dd78ecec93a82
855926diclofenac sodium 75 MG Delayed Release Oral TabletSCD2ac9fadc-dc84-4c4a-a12d-dd78ecec93a82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
76420-670-00764200670001000 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (76420-670-00) 2026-03-25NoNoHistorical
76420-670-0176420067001100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (76420-670-01) 2024-03-07NoNoHistorical
76420-670-0576420067005500 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (76420-670-05) 2026-03-25NoNoHistorical
76420-670-307642006703030 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (76420-670-30) 2024-03-07NoNoHistorical
76420-670-607642006706060 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (76420-670-60) 2024-03-07NoNoHistorical
76420-670-907642006709090 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (76420-670-90) 2024-03-07NoNoHistorical