FDA.reportPublic FDA data

Diclofenac Sodium

Product NDC
51021-250
11-digit product format
510210250
Labeler code
51021
Product ID
51021-250_83eada1e-9f07-953f-e053-2a91aa0aea0e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Sodium
Dosage form
SOLUTION/ DROPS
Route
TRANSDERMAL
Labeler
Sircle Laboratories, LLC
Application
ANDA204132
Marketing category
ANDA
Marketing start
2015-08-20
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
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201
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
51021-250-052024-01-30C16284748780-11030e365-25a7-111a-e063-dadaa90a10e2These 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 1.5% w/w is for topical use only. Initial U.S. Approval: 1988

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51021-250-05Capsinac150 mL in 1 BOTTLESOLUTION/ DROPS150 mL16.05 mg in 1mL3
51021-250-05Diclosaicin150 mL in 1 BOTTLESOLUTION/ DROPS150 mL16.05 mg in 1mL2
51021-250-05Diclofenac Sodium150 mL in 1 BOTTLESOLUTION/ DROPS1502
51021-250-05Iclofenac CP150 mL in 1 BOTTLESOLUTION/ DROPS150 mL16.05 mg in 1mL1
51021-250-05Ziclopro150 mL in 1 BOTTLESOLUTION/ DROPS150 mL16.05 mg in 1mL1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51021-250-05ML - Milliliter51021-2508f7230c4-b928-494c-a6d9-cd24964f0d0812016-07-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51021-250CAPSINAC (DICLOFENAC SODIUM AND CAPSAICIN) KIT [BODYSPHERE, LLC]3Legacy NDC20200828_a8b0e656-faef-4ac9-ace1-04241e5e241a.zip
51021-250DICLOFENAC SODIUM SOLUTION/ DROPS [SIRCLE LABORATORIES, LLC]2Legacy NDC, 1 package rows20190313_6f14d3bb-353d-4e03-beb7-6117a4a780bb.zip
51021-250DICLOSAICIN (DICLOFENAC SODIUM AND CAPSAICIN) KIT [CHADWICK PHARMACEUTICALS, INC]2Legacy NDC20220724_25e2ca69-236c-4282-85cd-3a4e1d9db024.zip
51021-250ICLOFENAC CP (DICLOFENAC SODIUM AND CAPSAICIN) KIT [CHADWICK PHARMACEUTICALS, INC]1Legacy NDC20211028_24dd02a2-2937-4d39-abe2-714d18cd2c3a.zip
51021-250ZICLOPRO (DICLOFENAC SODIUM AND CAPSAICIN) KIT [ASHOKA HEALTH]1Legacy NDC20210617_8b902129-03b4-4ab7-8ee7-160bd7f4c606.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857700diclofenac sodium 1.5 % Topical SolutionPSN20107264-e533-4de9-9a37-59fde7981c924
857700diclofenac sodium 15 MG/ML Topical SolutionSCD20107264-e533-4de9-9a37-59fde7981c924
857700diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical SolutionSY20107264-e533-4de9-9a37-59fde7981c924
857700diclofenac sodium 16.05 MG per 1 ML Topical SolutionSY20107264-e533-4de9-9a37-59fde7981c924
857700diclofenac sodium 1.5 % Topical SolutionPSNa8b0e656-faef-4ac9-ace1-04241e5e241a3
857700diclofenac sodium 1.5 % Topical SolutionPSN3d976518-60d2-478a-e054-00144ff88e883
857700diclofenac sodium 15 MG/ML Topical SolutionSCDa8b0e656-faef-4ac9-ace1-04241e5e241a3
857700diclofenac sodium 15 MG/ML Topical SolutionSCD3d976518-60d2-478a-e054-00144ff88e883
857700diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical SolutionSYa8b0e656-faef-4ac9-ace1-04241e5e241a3
857700diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical SolutionSY3d976518-60d2-478a-e054-00144ff88e883
857700diclofenac sodium 16.05 MG per 1 ML Topical SolutionSYa8b0e656-faef-4ac9-ace1-04241e5e241a3
857700diclofenac sodium 16.05 MG per 1 ML Topical SolutionSY3d976518-60d2-478a-e054-00144ff88e883
857700diclofenac sodium 1.5 % Topical SolutionPSN6f14d3bb-353d-4e03-beb7-6117a4a780bb2
857700diclofenac sodium 1.5 % Topical SolutionPSN25e2ca69-236c-4282-85cd-3a4e1d9db0242
857700diclofenac sodium 15 MG/ML Topical SolutionSCD25e2ca69-236c-4282-85cd-3a4e1d9db0242
857700diclofenac sodium 15 MG/ML Topical SolutionSCD6f14d3bb-353d-4e03-beb7-6117a4a780bb2
857700diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical SolutionSY6f14d3bb-353d-4e03-beb7-6117a4a780bb2
857700diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical SolutionSY25e2ca69-236c-4282-85cd-3a4e1d9db0242
857700diclofenac sodium 16.05 MG per 1 ML Topical SolutionSY25e2ca69-236c-4282-85cd-3a4e1d9db0242
857700diclofenac sodium 16.05 MG per 1 ML Topical SolutionSY6f14d3bb-353d-4e03-beb7-6117a4a780bb2
857700diclofenac sodium 1.5 % Topical SolutionPSN7dc7fb31-3323-7672-e053-2991aa0abff51
857700diclofenac sodium 1.5 % Topical SolutionPSNf3f60cd3-8f1f-4ca4-9621-805b4a6c35a81
857700diclofenac sodium 1.5 % Topical SolutionPSN8b902129-03b4-4ab7-8ee7-160bd7f4c6061
857700diclofenac sodium 1.5 % Topical SolutionPSN24dd02a2-2937-4d39-abe2-714d18cd2c3a1
857700diclofenac sodium 15 MG/ML Topical SolutionSCD7dc7fb31-3323-7672-e053-2991aa0abff51
857700diclofenac sodium 15 MG/ML Topical SolutionSCD8b902129-03b4-4ab7-8ee7-160bd7f4c6061
857700diclofenac sodium 15 MG/ML Topical SolutionSCD24dd02a2-2937-4d39-abe2-714d18cd2c3a1
857700diclofenac sodium 15 MG/ML Topical SolutionSCDf3f60cd3-8f1f-4ca4-9621-805b4a6c35a81
857700diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical SolutionSY7dc7fb31-3323-7672-e053-2991aa0abff51
857700diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical SolutionSY8b902129-03b4-4ab7-8ee7-160bd7f4c6061
857700diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical SolutionSYf3f60cd3-8f1f-4ca4-9621-805b4a6c35a81
857700diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical SolutionSY24dd02a2-2937-4d39-abe2-714d18cd2c3a1
857700diclofenac sodium 16.05 MG per 1 ML Topical SolutionSYf3f60cd3-8f1f-4ca4-9621-805b4a6c35a81
857700diclofenac sodium 16.05 MG per 1 ML Topical SolutionSY24dd02a2-2937-4d39-abe2-714d18cd2c3a1
857700diclofenac sodium 16.05 MG per 1 ML Topical SolutionSY8b902129-03b4-4ab7-8ee7-160bd7f4c6061
857700diclofenac sodium 16.05 MG per 1 ML Topical SolutionSY7dc7fb31-3323-7672-e053-2991aa0abff51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51021-250-0551021025005150 mL in 1 BOTTLE (51021-250-05) 150 ml2016-05-300000-00-00NoNoCurrent