FDA.reportPublic FDA data

Diclofenac Sodium

Product NDC
60505-0399
11-digit product format
605050399
Labeler code
60505
Product ID
60505-0399_e3840ac9-7879-6607-42de-5f6dbf78c23d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Sodium
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Apotex Corp.
Application
ANDA202027
Marketing category
ANDA
Marketing start
2014-05-28
Marketing end
0000-00-00
Substance
DICLOFENAC SODIUM
Active strength
16 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
2023-12-31
Current FDA listing
Historical FDA.report record

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
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201
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
60505-0399-5Varophen1 in 1 CARTONSOLUTION16.05 mg in 1mL5
60505-0399-5Varophen150 mL in 1 BOTTLESOLUTION150 mL16.05 mg in 1mL5
60505-0399-5Diclotral Pak150 mL in 1 BOTTLESOLUTION150 mL16.05 mg in 1mL4
60505-0399-5Diclotral Pak1 in 1 CARTONSOLUTION16.05 mg in 1mL4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-0399-5ML - Milliliter60505-03990fcc0d41-2908-48b7-8c54-3300c0909a3312014-06-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-0399VAROPHEN (DICLOFENAC SODIUM AND MENTHOL, METHYL SALICYLATE) KIT [V2 PHARMA, LLC]5Legacy NDC20250101_1bef5035-70ad-4f75-80c3-6252cd01fa85.zip
60505-0399DICLOTRAL PAK (DICLOFENAC SODIUM, CAPSAICIN) KIT [PATCHWERX LABS, INC.]4Legacy NDC20160312_2d8f4048-14cb-7484-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857700diclofenac sodium 1.5 % Topical SolutionPSN1bef5035-70ad-4f75-80c3-6252cd01fa855
311498menthol 10 % / methyl salicylate 15 % Topical CreamPSN1bef5035-70ad-4f75-80c3-6252cd01fa855
857700diclofenac sodium 15 MG/ML Topical SolutionSCD1bef5035-70ad-4f75-80c3-6252cd01fa855
311498menthol 100 MG/ML / methyl salicylate 150 MG/ML Topical CreamSCD1bef5035-70ad-4f75-80c3-6252cd01fa855
857700diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical SolutionSY1bef5035-70ad-4f75-80c3-6252cd01fa855
857700diclofenac sodium 16.05 MG per 1 ML Topical SolutionSY1bef5035-70ad-4f75-80c3-6252cd01fa855
311498menthol 10 % / methyl salicylate 15 % Topical CreamSY1bef5035-70ad-4f75-80c3-6252cd01fa855
311498menthol 10 GM / methyl salicylate 15 GM per 100 GM Topical CreamSY1bef5035-70ad-4f75-80c3-6252cd01fa855
198555capsaicin 0.025 % Topical CreamPSN2d8f4048-14cb-7484-e054-00144ff88e884
857700diclofenac sodium 1.5 % Topical SolutionPSN2d8f4048-14cb-7484-e054-00144ff88e884
198555capsaicin 0.25 MG/ML Topical CreamSCD2d8f4048-14cb-7484-e054-00144ff88e884
857700diclofenac sodium 15 MG/ML Topical SolutionSCD2d8f4048-14cb-7484-e054-00144ff88e884
198555capsaicin 0.025 % Topical CreamSY2d8f4048-14cb-7484-e054-00144ff88e884
857700diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical SolutionSY2d8f4048-14cb-7484-e054-00144ff88e884
857700diclofenac sodium 16.05 MG per 1 ML Topical SolutionSY2d8f4048-14cb-7484-e054-00144ff88e884
857700diclofenac sodium 1.5 % Topical SolutionPSN5cd96e45-e027-3c9a-e053-2a91aa0a807e2
857700diclofenac sodium 1.5 % Topical SolutionPSNaa272926-7fe0-4e43-9a64-bfeb8cbf0c192
857700diclofenac sodium 15 MG/ML Topical SolutionSCD5cd96e45-e027-3c9a-e053-2a91aa0a807e2
857700diclofenac sodium 15 MG/ML Topical SolutionSCDaa272926-7fe0-4e43-9a64-bfeb8cbf0c192
857700diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical SolutionSY5cd96e45-e027-3c9a-e053-2a91aa0a807e2
857700diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical SolutionSYaa272926-7fe0-4e43-9a64-bfeb8cbf0c192
857700diclofenac sodium 16.05 MG per 1 ML Topical SolutionSY5cd96e45-e027-3c9a-e053-2a91aa0a807e2
857700diclofenac sodium 16.05 MG per 1 ML Topical SolutionSYaa272926-7fe0-4e43-9a64-bfeb8cbf0c192
857700diclofenac sodium 1.5 % Topical SolutionPSN2bf4c5e6-8486-473f-9692-34394079ec2c1
857700diclofenac sodium 15 MG/ML Topical SolutionSCD2bf4c5e6-8486-473f-9692-34394079ec2c1
857700diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical SolutionSY2bf4c5e6-8486-473f-9692-34394079ec2c1
857700diclofenac sodium 16.05 MG per 1 ML Topical SolutionSY2bf4c5e6-8486-473f-9692-34394079ec2c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60505-0399-5605050399051 BOTTLE in 1 CARTON (60505-0399-5) > 150 mL in 1 BOTTLE1 bottle2014-05-280000-00-00NoNoCurrent