FDA.reportPublic FDA data

Diclofenac sodium

Product NDC
71085-002
11-digit product format
710850002
Labeler code
71085
Product ID
71085-002_aa6f3401-4aad-43cc-9e01-12ffaf89a0ac
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diclofenac sodium
Dosage form
SOLUTION
Route
TOPICAL
Labeler
IPG PHARMACEUTICALS, INC.
Application
ANDA203818
Marketing category
ANDA
Marketing start
2014-11-26
Marketing end
0000-00-00
Substance
DICLOFENAC SODIUM
Active strength
16 mg/mL
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71085-002-052025-12-29C16284748780-12cef2736-ab1b-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use DICLOFENAC SODIUM TOPICAL SOLUTION safely and effectively. See full prescribing information for DICLOFENAC SODIUM TOPICAL SOLUTION. DICLOFENAC SODIUM topical solution, for topical use. Initial U.S. Approval: 1988
71085-002-052025-01-30C16284748780-12cef2736-ab1b-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use DICLOFENAC SODIUM TOPICAL SOLUTION safely and effectively. See full prescribing information for DICLOFENAC SODIUM TOPICAL SOLUTION. DICLOFENAC SODIUM topical solution, for topical use. Initial U.S. Approval: 1988

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71085-002-05ML - Milliliter71085-002d5270be7-6374-4b5a-9a74-6ea21fb95f1212017-06-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71085-002DICLOFENAC SODIUM SOLUTION [IPG PHARMACEUTICALS, INC.]2Legacy NDC20191127_f491253d-14ab-4063-b57f-eb9254c1d833.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857700diclofenac sodium 1.5 % Topical SolutionPSNb0f9e649-6651-406f-a9fe-157fe04d9d274
857700diclofenac sodium 15 MG/ML Topical SolutionSCDb0f9e649-6651-406f-a9fe-157fe04d9d274
857700diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical SolutionSYb0f9e649-6651-406f-a9fe-157fe04d9d274
857700diclofenac sodium 16.05 MG per 1 ML Topical SolutionSYb0f9e649-6651-406f-a9fe-157fe04d9d274
857700diclofenac sodium 1.5 % Topical SolutionPSN674b72e7-6ece-b2a4-e053-2a91aa0a0ab72
857700diclofenac sodium 1.5 % Topical SolutionPSNa9c06a58-d8c2-43ba-a6ae-3f5824e38b9e2
857700diclofenac sodium 15 MG/ML Topical SolutionSCD674b72e7-6ece-b2a4-e053-2a91aa0a0ab72
857700diclofenac sodium 15 MG/ML Topical SolutionSCDa9c06a58-d8c2-43ba-a6ae-3f5824e38b9e2
857700diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical SolutionSY674b72e7-6ece-b2a4-e053-2a91aa0a0ab72
857700diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical SolutionSYa9c06a58-d8c2-43ba-a6ae-3f5824e38b9e2
857700diclofenac sodium 16.05 MG per 1 ML Topical SolutionSYa9c06a58-d8c2-43ba-a6ae-3f5824e38b9e2
857700diclofenac sodium 16.05 MG per 1 ML Topical SolutionSY674b72e7-6ece-b2a4-e053-2a91aa0a0ab72
857700diclofenac sodium 1.5 % Topical SolutionPSN82a170b6-fd2c-48ad-97dc-bd4e9c85f53e1
857700diclofenac sodium 1.5 % Topical SolutionPSNe786e7bf-a143-428d-b3e2-bc82eca2f2661
1600976menthol 10 % Topical SolutionPSN82a170b6-fd2c-48ad-97dc-bd4e9c85f53e1
1600976menthol 10 % Topical SolutionPSNe786e7bf-a143-428d-b3e2-bc82eca2f2661
857700diclofenac sodium 15 MG/ML Topical SolutionSCD82a170b6-fd2c-48ad-97dc-bd4e9c85f53e1
857700diclofenac sodium 15 MG/ML Topical SolutionSCDe786e7bf-a143-428d-b3e2-bc82eca2f2661
1600976menthol 100 MG/ML Topical SolutionSCD82a170b6-fd2c-48ad-97dc-bd4e9c85f53e1
1600976menthol 100 MG/ML Topical SolutionSCDe786e7bf-a143-428d-b3e2-bc82eca2f2661
857700diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical SolutionSY82a170b6-fd2c-48ad-97dc-bd4e9c85f53e1
857700diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical SolutionSYe786e7bf-a143-428d-b3e2-bc82eca2f2661
857700diclofenac sodium 16.05 MG per 1 ML Topical SolutionSY82a170b6-fd2c-48ad-97dc-bd4e9c85f53e1
857700diclofenac sodium 16.05 MG per 1 ML Topical SolutionSYe786e7bf-a143-428d-b3e2-bc82eca2f2661
1600976menthol 10 % Topical SolutionSY82a170b6-fd2c-48ad-97dc-bd4e9c85f53e1
1600976menthol 10 % Topical SolutionSYe786e7bf-a143-428d-b3e2-bc82eca2f2661

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71085-002-05710850002051 BOTTLE, DROPPER in 1 CARTON (71085-002-05) > 150 mL in 1 BOTTLE, DROPPER2017-02-080000-00-00NoNoCurrent