FDA.reportPublic FDA data

Diclofenac Sodium

Product NDC
85509-1201
11-digit product format
855091201
Labeler code
85509
Product ID
85509-1201_47ce6fbc-b69b-f4de-e063-6294a90ae435
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
PHOENIX RX LLC
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
Rxcui855926

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
85509-1201-3Diclofenac Sodium30 in 1 BOTTLETABLET, DELAYED RELEASE301
85509-1201-6Diclofenac Sodium60 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE601
85509-1201-9Diclofenac Sodium90 in 1 BOTTLETABLET, DELAYED RELEASE901

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855926diclofenac sodium 75 MG Delayed Release Oral TabletPSN47ce6fab-be1d-0076-e063-6294a90add631
855926diclofenac sodium 75 MG Delayed Release Oral TabletSCD47ce6fab-be1d-0076-e063-6294a90add631

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
85509-1201-38550912010330 TABLET, DELAYED RELEASE in 1 BOTTLE (85509-1201-3) 2026-01-07NoNoCurrent
85509-1201-68550912010660 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (85509-1201-6) 2026-01-07NoNoCurrent
85509-1201-98550912010990 TABLET, DELAYED RELEASE in 1 BOTTLE (85509-1201-9) 2026-01-07NoNoCurrent