FDA.reportPublic FDA data

Diclofenac Sodium

Product NDC
65162-911
11-digit product format
651620911
Labeler code
65162
Product ID
65162-911_6feda2fe-70b6-4dbe-a969-97857501dd1f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA206116
Marketing category
ANDA
Marketing start
2016-09-02
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
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
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
65162-911-74Diclofenac Sodium1 in 1 CARTONSOLUTION122
65162-911-74Diclofenac Sodium150 mL in 1 BOTTLESOLUTION15022
65162-911-74Fenovar150 mL in 1 BOTTLESOLUTION150 mL16.05 mg in 1mL7
65162-911-74Fenovar1 in 1 CARTONSOLUTION16.05 mg in 1mL7
65162-911-74Orthrexo1 in 1 CARTONSOLUTION16.05 mg in 1mL1
65162-911-74Orthaphen150 mL in 1 BOTTLESOLUTION150 mL16.05 mg in 1mL1
65162-911-74Orthaphen1 in 1 CARTONSOLUTION16.05 mg in 1mL1
65162-911-74Torvex150 mL in 1 BOTTLESOLUTION150 mL16.05 mg in 1mL1
65162-911-74Orthrexo150 mL in 1 BOTTLESOLUTION150 mL16.05 mg in 1mL1
65162-911-74Torvex1 in 1 CARTONSOLUTION16.05 mg in 1mL1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65162-911-74ML - Milliliter65162-91130077597-76c0-4ba1-aae4-2a735eff933d12016-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-911DICLOFENAC SODIUM (DICLOFENAC) SOLUTION [AMNEAL PHARMACEUTICALS LLC]22Current NDC, Legacy NDC, 2 package rows20241222_78873f83-cea9-44d4-8ad4-8cb9257e5c7f.zip
65162-911FENOVAR (DICLOFENAC SODIUM AND MENTHOL, METHYL SALICYLATE) KIT [V2 PHARMA, LLC]7Current NDC, Legacy NDC20241103_cca25bd7-2afd-4ff1-adb3-0a77dfcd4342.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857700diclofenac sodium 1.5 % Topical SolutionPSNe5f8284a-1aa9-4a36-a6ad-fa153c613f34100
857700diclofenac sodium 15 MG/ML Topical SolutionSCDe5f8284a-1aa9-4a36-a6ad-fa153c613f34100
857700diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical SolutionSYe5f8284a-1aa9-4a36-a6ad-fa153c613f34100
857700diclofenac sodium 16.05 MG per 1 ML Topical SolutionSYe5f8284a-1aa9-4a36-a6ad-fa153c613f34100
857700diclofenac sodium 1.5 % Topical SolutionPSN78873f83-cea9-44d4-8ad4-8cb9257e5c7f22
857700diclofenac sodium 15 MG/ML Topical SolutionSCD78873f83-cea9-44d4-8ad4-8cb9257e5c7f22
857700diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical SolutionSY78873f83-cea9-44d4-8ad4-8cb9257e5c7f22
857700diclofenac sodium 16.05 MG per 1 ML Topical SolutionSY78873f83-cea9-44d4-8ad4-8cb9257e5c7f22
857700diclofenac sodium 1.5 % Topical SolutionPSN58178f0d-3960-48e3-91ba-150f691be24112
857700diclofenac sodium 15 MG/ML Topical SolutionSCD58178f0d-3960-48e3-91ba-150f691be24112
857700diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical SolutionSY58178f0d-3960-48e3-91ba-150f691be24112
857700diclofenac sodium 16.05 MG per 1 ML Topical SolutionSY58178f0d-3960-48e3-91ba-150f691be24112
857700diclofenac sodium 1.5 % Topical SolutionPSN937e9ba5-cdad-4e72-a77a-bad699e1b23610
857700diclofenac sodium 15 MG/ML Topical SolutionSCD937e9ba5-cdad-4e72-a77a-bad699e1b23610
857700diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical SolutionSY937e9ba5-cdad-4e72-a77a-bad699e1b23610
857700diclofenac sodium 16.05 MG per 1 ML Topical SolutionSY937e9ba5-cdad-4e72-a77a-bad699e1b23610
857700diclofenac sodium 1.5 % Topical SolutionPSNcca25bd7-2afd-4ff1-adb3-0a77dfcd43427
311498menthol 10 % / methyl salicylate 15 % Topical CreamPSNcca25bd7-2afd-4ff1-adb3-0a77dfcd43427
857700diclofenac sodium 15 MG/ML Topical SolutionSCDcca25bd7-2afd-4ff1-adb3-0a77dfcd43427
311498menthol 100 MG/ML / methyl salicylate 150 MG/ML Topical CreamSCDcca25bd7-2afd-4ff1-adb3-0a77dfcd43427
857700diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical SolutionSYcca25bd7-2afd-4ff1-adb3-0a77dfcd43427
857700diclofenac sodium 16.05 MG per 1 ML Topical SolutionSYcca25bd7-2afd-4ff1-adb3-0a77dfcd43427
311498menthol 10 % / methyl salicylate 15 % Topical CreamSYcca25bd7-2afd-4ff1-adb3-0a77dfcd43427
311498menthol 10 GM / methyl salicylate 15 GM per 100 GM Topical CreamSYcca25bd7-2afd-4ff1-adb3-0a77dfcd43427
857700diclofenac sodium 1.5 % Topical SolutionPSN26a58eef-f968-4781-93eb-0b3c71825f455
857700diclofenac sodium 15 MG/ML Topical SolutionSCD26a58eef-f968-4781-93eb-0b3c71825f455
857700diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical SolutionSY26a58eef-f968-4781-93eb-0b3c71825f455
857700diclofenac sodium 16.05 MG per 1 ML Topical SolutionSY26a58eef-f968-4781-93eb-0b3c71825f455
857700diclofenac sodium 1.5 % Topical SolutionPSNa5b33bf7-8113-9c54-e053-2995a90a79d84
857700diclofenac sodium 1.5 % Topical SolutionPSNf1896c84-b18a-d49d-e053-2995a90aaab34
857700diclofenac sodium 15 MG/ML Topical SolutionSCDf1896c84-b18a-d49d-e053-2995a90aaab34
857700diclofenac sodium 15 MG/ML Topical SolutionSCDa5b33bf7-8113-9c54-e053-2995a90a79d84
857700diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical SolutionSYa5b33bf7-8113-9c54-e053-2995a90a79d84
857700diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical SolutionSYf1896c84-b18a-d49d-e053-2995a90aaab34
857700diclofenac sodium 16.05 MG per 1 ML Topical SolutionSYf1896c84-b18a-d49d-e053-2995a90aaab34
857700diclofenac sodium 16.05 MG per 1 ML Topical SolutionSYa5b33bf7-8113-9c54-e053-2995a90a79d84
857700diclofenac sodium 1.5 % Topical SolutionPSN9df599de-6412-a94e-e053-2995a90a17412
857700diclofenac sodium 15 MG/ML Topical SolutionSCD9df599de-6412-a94e-e053-2995a90a17412
857700diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical SolutionSY9df599de-6412-a94e-e053-2995a90a17412
857700diclofenac sodium 16.05 MG per 1 ML Topical SolutionSY9df599de-6412-a94e-e053-2995a90a17412
857700diclofenac sodium 1.5 % Topical SolutionPSN55a35d04-d75b-4e76-972f-4710035763c91
857700diclofenac sodium 1.5 % Topical SolutionPSN450bb971-1be7-48fc-bb3f-200382962b8c1
857700diclofenac sodium 1.5 % Topical SolutionPSNf4da38af-c5bd-4d4a-a6f3-c2933f2238091
857700diclofenac sodium 1.5 % Topical SolutionPSN41dab520-5651-a4c5-e063-6394a90a29621
857700diclofenac sodium 1.5 % Topical SolutionPSN9af22c87-affe-a7f5-e053-2a95a90a9b521
857700diclofenac sodium 1.5 % Topical SolutionPSN1583e691-5823-4a68-aafc-bf80b88542331
857700diclofenac sodium 1.5 % Topical SolutionPSNeb070904-4f6f-42c0-981d-8dc8500401851
311498menthol 10 % / methyl salicylate 15 % Topical CreamPSNeb070904-4f6f-42c0-981d-8dc8500401851
311498menthol 10 % / methyl salicylate 15 % Topical CreamPSN55a35d04-d75b-4e76-972f-4710035763c91
311498menthol 10 % / methyl salicylate 15 % Topical CreamPSN1583e691-5823-4a68-aafc-bf80b88542331
857700diclofenac sodium 15 MG/ML Topical SolutionSCD9af22c87-affe-a7f5-e053-2a95a90a9b521
857700diclofenac sodium 15 MG/ML Topical SolutionSCDeb070904-4f6f-42c0-981d-8dc8500401851
857700diclofenac sodium 15 MG/ML Topical SolutionSCDf4da38af-c5bd-4d4a-a6f3-c2933f2238091
857700diclofenac sodium 15 MG/ML Topical SolutionSCD1583e691-5823-4a68-aafc-bf80b88542331
857700diclofenac sodium 15 MG/ML Topical SolutionSCD41dab520-5651-a4c5-e063-6394a90a29621
857700diclofenac sodium 15 MG/ML Topical SolutionSCD450bb971-1be7-48fc-bb3f-200382962b8c1
857700diclofenac sodium 15 MG/ML Topical SolutionSCD55a35d04-d75b-4e76-972f-4710035763c91
311498menthol 100 MG/ML / methyl salicylate 150 MG/ML Topical CreamSCD1583e691-5823-4a68-aafc-bf80b88542331
311498menthol 100 MG/ML / methyl salicylate 150 MG/ML Topical CreamSCD55a35d04-d75b-4e76-972f-4710035763c91
311498menthol 100 MG/ML / methyl salicylate 150 MG/ML Topical CreamSCDeb070904-4f6f-42c0-981d-8dc8500401851
857700diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical SolutionSY41dab520-5651-a4c5-e063-6394a90a29621
857700diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical SolutionSYf4da38af-c5bd-4d4a-a6f3-c2933f2238091
857700diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical SolutionSY450bb971-1be7-48fc-bb3f-200382962b8c1
857700diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical SolutionSY1583e691-5823-4a68-aafc-bf80b88542331
857700diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical SolutionSY55a35d04-d75b-4e76-972f-4710035763c91
857700diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical SolutionSY9af22c87-affe-a7f5-e053-2a95a90a9b521
857700diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical SolutionSYeb070904-4f6f-42c0-981d-8dc8500401851
857700diclofenac sodium 16.05 MG per 1 ML Topical SolutionSYf4da38af-c5bd-4d4a-a6f3-c2933f2238091
857700diclofenac sodium 16.05 MG per 1 ML Topical SolutionSY9af22c87-affe-a7f5-e053-2a95a90a9b521
857700diclofenac sodium 16.05 MG per 1 ML Topical SolutionSYeb070904-4f6f-42c0-981d-8dc8500401851
857700diclofenac sodium 16.05 MG per 1 ML Topical SolutionSY55a35d04-d75b-4e76-972f-4710035763c91
857700diclofenac sodium 16.05 MG per 1 ML Topical SolutionSY450bb971-1be7-48fc-bb3f-200382962b8c1
857700diclofenac sodium 16.05 MG per 1 ML Topical SolutionSY41dab520-5651-a4c5-e063-6394a90a29621
857700diclofenac sodium 16.05 MG per 1 ML Topical SolutionSY1583e691-5823-4a68-aafc-bf80b88542331
311498menthol 10 % / methyl salicylate 15 % Topical CreamSYeb070904-4f6f-42c0-981d-8dc8500401851
311498menthol 10 % / methyl salicylate 15 % Topical CreamSY55a35d04-d75b-4e76-972f-4710035763c91
311498menthol 10 % / methyl salicylate 15 % Topical CreamSY1583e691-5823-4a68-aafc-bf80b88542331
311498menthol 10 GM / methyl salicylate 15 GM per 100 GM Topical CreamSYeb070904-4f6f-42c0-981d-8dc8500401851
311498menthol 10 GM / methyl salicylate 15 GM per 100 GM Topical CreamSY1583e691-5823-4a68-aafc-bf80b88542331
311498menthol 10 GM / methyl salicylate 15 GM per 100 GM Topical CreamSY55a35d04-d75b-4e76-972f-4710035763c91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65162-911-74651620911741 BOTTLE in 1 CARTON (65162-911-74) / 150 mL in 1 BOTTLE1 bottle2016-09-020000-00-00NoNoCurrent