FDA.reportPublic FDA data

Diclofenac Sodium

Product NDC
42799-953
11-digit product format
427990953
Labeler code
42799
Product ID
42799-953_50827dab-3a98-4af3-ba36-3afcd814c6e3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Sodium
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Edenbridge Pharmaceuticals LLC.
Application
ANDA076201
Marketing category
ANDA
Marketing start
2002-11-06
Substance
DICLOFENAC SODIUM
Active strength
100 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 SODIUM100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQTG126297Q
Rxcui855657

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
42799-953-01Diclofenac Sodium100 in 1 BOTTLETABLET, EXTENDED RELEASE1005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42799-953-01EA - Each42799-953b2be5f99-0684-4e43-9c3b-97bc3728306912023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42799-953DICLOFENAC SODIUM TABLET, EXTENDED RELEASE [EDENBRIDGE PHARMACEUTICALS LLC.]3Current NDC, 1 package rows20240622_bd25a2b1-a4d5-4893-97d1-efdcd414a97d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855657diclofenac sodium 100 MG 24HR Extended Release Oral TabletPSNbd25a2b1-a4d5-4893-97d1-efdcd414a97d5
85565724 HR diclofenac sodium 100 MG Extended Release Oral TabletSCDbd25a2b1-a4d5-4893-97d1-efdcd414a97d5
855657diclofenac sodium 100 MG 24 HR Extended Release Oral TabletSYbd25a2b1-a4d5-4893-97d1-efdcd414a97d5
855657diclofenac sodium 100 MG 24HR Extended Release Oral TabletPSN26e44aa5-cfcd-f10b-e063-6394a90a4dcf1
855657diclofenac sodium 100 MG 24HR Extended Release Oral TabletPSN4ddd7e34-e5f4-8f05-e063-6294a90a70aa1
85565724 HR diclofenac sodium 100 MG Extended Release Oral TabletSCD26e44aa5-cfcd-f10b-e063-6394a90a4dcf1
85565724 HR diclofenac sodium 100 MG Extended Release Oral TabletSCD4ddd7e34-e5f4-8f05-e063-6294a90a70aa1
855657diclofenac sodium 100 MG 24 HR Extended Release Oral TabletSY26e44aa5-cfcd-f10b-e063-6394a90a4dcf1
855657diclofenac sodium 100 MG 24 HR Extended Release Oral TabletSY4ddd7e34-e5f4-8f05-e063-6294a90a70aa1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
42799-953-0142799095301100 TABLET, EXTENDED RELEASE in 1 BOTTLE (42799-953-01) 2023-06-14NoNoHistorical