FDA.reportPublic FDA data

Diclofenac sodium

Product NDC
65162-833
11-digit product format
651620833
Labeler code
65162
Product ID
65162-833_d75a1014-b404-4c4c-95c2-ce4ca9ac779d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac
Dosage form
GEL
Route
TOPICAL
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA208077
Marketing category
ANDA
Marketing start
2016-03-21
Marketing end
0000-00-00
Substance
DICLOFENAC SODIUM
Active strength
10 mg/g
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
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
65162-833-662021-02-05C16284748780-1ba0f9c33-1731-a910-e053-dadaa90a0b85f64b68a5-d6d2-4e92-87e7-90af04c1f9db
65162-833-662021-01-29C16284748780-1ba0f9c33-1731-a910-e053-dadaa90a0b85f64b68a5-d6d2-4e92-87e7-90af04c1f9db

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65162-833-66VennGel One1 in 1 CARTONGEL10 mg in 1g8
65162-833-66VennGel One100 g in 1 TUBEGEL100 g10 mg in 1g8
65162-833-66LidoPR100 g in 1 TUBEGEL300 g10 mg in 1g5
65162-833-66LidoPR1 in 1 CARTONGEL10 mg in 1g5
65162-833-66DicloPR100 g in 1 TUBEGEL300 g10 mg in 1g3
65162-833-66DicloPR1 in 1 CARTONGEL10 mg in 1g3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65162-833-66GM - Gram65162-83347705cfa-1ad3-43f0-9d00-1bb19417479e12016-04-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-833VENNGEL ONE (DICLOFENAC SODIUM, ISOPROPYL ALCOHOL) KIT [PURETEK CORPORATION]8Legacy NDC20241208_e0979152-132e-466b-8b56-87826f190c89.zip
65162-833LIDOPR (DICLOFENAC GEL, METHYL SALICYLATE, MENTHOL CREAM) KIT [19 AND PACIFIC, LLC]5Legacy NDC20171029_ec864730-a727-4a3d-a752-b03f4bd86988.zip
65162-833DICLOPR (DICLOFENAC GEL, METHYL SALICYLATE, MENTHOL CREAM) KIT [19 AND PACIFIC, LLC]3Legacy NDC20171113_fa136af1-d3ea-4038-95af-e937555f8f5d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855633diclofenac sodium 1 % Topical GelPSNa48f7371-f6d4-4444-adb2-9c4d0b25a07811
855633diclofenac sodium 0.01 MG/MG Topical GelSCDa48f7371-f6d4-4444-adb2-9c4d0b25a07811
855633diclofenac sodium 1 % Topical GelSYa48f7371-f6d4-4444-adb2-9c4d0b25a07811
855633diclofenac sodium 1 % Topical GelPSNe0979152-132e-466b-8b56-87826f190c898
855633diclofenac sodium 0.01 MG/MG Topical GelSCDe0979152-132e-466b-8b56-87826f190c898
855633diclofenac sodium 1 % Topical GelSYe0979152-132e-466b-8b56-87826f190c898
855633diclofenac sodium 1 % Topical GelPSNec864730-a727-4a3d-a752-b03f4bd869885
311500menthol 10 % / methyl salicylate 30 % Topical CreamPSNec864730-a727-4a3d-a752-b03f4bd869885
855633diclofenac sodium 0.01 MG/MG Topical GelSCDec864730-a727-4a3d-a752-b03f4bd869885
311500menthol 100 MG/ML / methyl salicylate 300 MG/ML Topical CreamSCDec864730-a727-4a3d-a752-b03f4bd869885
855633diclofenac sodium 1 % Topical GelSYec864730-a727-4a3d-a752-b03f4bd869885
311500menthol 10 % / methyl salicylate 30 % Topical CreamSYec864730-a727-4a3d-a752-b03f4bd869885
855633diclofenac sodium 1 % Topical GelPSNfa136af1-d3ea-4038-95af-e937555f8f5d3
311500menthol 10 % / methyl salicylate 30 % Topical CreamPSNfa136af1-d3ea-4038-95af-e937555f8f5d3
855633diclofenac sodium 0.01 MG/MG Topical GelSCDfa136af1-d3ea-4038-95af-e937555f8f5d3
311500menthol 100 MG/ML / methyl salicylate 300 MG/ML Topical CreamSCDfa136af1-d3ea-4038-95af-e937555f8f5d3
855633diclofenac sodium 1 % Topical GelSYfa136af1-d3ea-4038-95af-e937555f8f5d3
311500menthol 10 % / methyl salicylate 30 % Topical CreamSYfa136af1-d3ea-4038-95af-e937555f8f5d3
855633diclofenac sodium 1 % Topical GelPSNf21afee1-b556-4231-a18a-daaf9af6d2e22
855633diclofenac sodium 0.01 MG/MG Topical GelSCDf21afee1-b556-4231-a18a-daaf9af6d2e22
855633diclofenac sodium 1 % Topical GelSYf21afee1-b556-4231-a18a-daaf9af6d2e22
855633diclofenac sodium 1 % Topical GelPSNce627b49-2c88-44bb-ad3f-f077510ae5fa1
855633diclofenac sodium 0.01 MG/MG Topical GelSCDce627b49-2c88-44bb-ad3f-f077510ae5fa1
855633diclofenac sodium 1 % Topical GelSYce627b49-2c88-44bb-ad3f-f077510ae5fa1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65162-833-66651620833661 TUBE in 1 CARTON (65162-833-66) > 100 g in 1 TUBE1 tube2016-03-210000-00-00NoNoCurrent