FDA.reportPublic FDA data

Diclofenac sodium

Product NDC
80425-0414
11-digit product format
804250414
Labeler code
80425
Product ID
80425-0414_1d4d39a7-d22b-aa13-e063-6294a90a05f9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diclofenac sodium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Advanced Rx of Tennessee, LLC
Application
ANDA216275
Marketing category
ANDA
Marketing start
2024-07-11
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Diclofenac sodium
Listing expiration
2026-12-31

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
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
80425-0414-1Diclofenac sodium30 in 1 BOTTLE, PLASTICTABLET, FILM COATED301
80425-0414-2Diclofenac sodium60 in 1 BOTTLE, PLASTICTABLET, FILM COATED601
80425-0414-3Diclofenac sodium90 in 1 BOTTLE, PLASTICTABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0414-1EA - Each80425-04140a978265-5f78-4a27-9270-21b9667ed64312024-08-12
80425-0414-2EA - Each80425-041435406b09-85d0-456c-aaf7-bfab9170221c12024-08-12
80425-0414-3EA - Each80425-041497b0db2e-5d82-4941-b8fa-09e49aa75a5612024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0414DICLOFENAC SODIUM TABLET, FILM COATED [ADVANCED RX OF TENNESSEE, LLC]1Current NDC, 3 package rows20240716_1d4d6370-2b45-fa6d-e063-6294a90a4a67.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855657diclofenac sodium 100 MG 24HR Extended Release Oral TabletPSN1d4d6370-2b45-fa6d-e063-6294a90a4a671
85565724 HR diclofenac sodium 100 MG Extended Release Oral TabletSCD1d4d6370-2b45-fa6d-e063-6294a90a4a671
855657diclofenac sodium 100 MG 24 HR Extended Release Oral TabletSY1d4d6370-2b45-fa6d-e063-6294a90a4a671

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
80425-0414-18042504140130 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80425-0414-1) 2024-07-11NoNoHistorical
80425-0414-28042504140260 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80425-0414-2) 2024-07-11NoNoHistorical
80425-0414-38042504140390 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80425-0414-3) 2024-07-11NoNoHistorical