FDA.reportPublic FDA data

Diclofenac Sodium

Product NDC
80425-0240
11-digit product format
804250240
Labeler code
80425
Product ID
80425-0240_28881f46-72e4-e43f-e063-6394a90aca93
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Sodium
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Advanced Rx of Tennessee, LLC
Application
ANDA204132
Marketing category
ANDA
Marketing start
2023-01-10
Substance
DICLOFENAC SODIUM
Active strength
16.05 mg/mL
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 SODIUM16.05 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQTG126297Q
Rxcui857700

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
80425-0240-1Diclofenac Sodium1 in 1 CARTONSOLUTION14
80425-0240-1Diclofenac Sodium150 mL in 1 BOTTLESOLUTION1504

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0240-1ML - Milliliter80425-02406702d75b-7bd1-4253-8d0c-c1a1e471547d12023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0240DICLOFENAC SODIUM SOLUTION [ADVANCED RX OF TENNESSEE, LLC]4Current NDC, 2 package rows20241208_f18a4691-93a1-01e6-e053-2995a90a0069.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857700diclofenac sodium 1.5 % Topical SolutionPSNf18a4691-93a1-01e6-e053-2995a90a00694
857700diclofenac sodium 15 MG/ML Topical SolutionSCDf18a4691-93a1-01e6-e053-2995a90a00694
857700diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical SolutionSYf18a4691-93a1-01e6-e053-2995a90a00694
857700diclofenac sodium 16.05 MG per 1 ML Topical SolutionSYf18a4691-93a1-01e6-e053-2995a90a00694

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80425-0240-1804250240011 BOTTLE in 1 CARTON (80425-0240-1) / 150 mL in 1 BOTTLE1 bottle2023-01-10NoNoHistorical