FDA.reportPublic FDA data

Diclofenac Sodium

Product NDC
21922-009
11-digit product format
219220009
Labeler code
21922
Product ID
21922-009_6ed03146-b87c-473e-846f-2643dd3593db
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Sodium Topical Gel, 1%,
Dosage form
GEL
Route
TOPICAL
Labeler
Encube Ethicals Private Limited
Application
ANDA210986
Marketing category
ANDA
Marketing start
2020-01-30
Marketing end
0000-00-00
Substance
DICLOFENAC SODIUM
Active strength
10 mg/g
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
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
111d457e-3138-4512-b0ba-d0cd760c4055Product name320250225
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
0426261e-1bb9-b78b-abd2-80da765a7e3eProduct name220240513
7b6158ae-c3f4-3d73-c35f-6f5d18b9efd7Product name520240320
0ac2f11f-f58d-baf2-71a0-680993b48a61Product name220231211
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
855d63c3-b090-4636-8fc7-6d39ad23c44fProduct name120230829
bb58f410-04be-65dd-9211-e89ead899698Product name620230323
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
0fcbc38a-8b29-3348-1cef-5222ea53484fProduct name420220516
c4e1eedc-aca2-4551-8382-89144ed9d049Product name320220126
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
8d368a34-1453-43ea-828d-0dbcd72b8794Product name820210622
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
d6bab9d2-edce-a213-4796-226ab15472c3Product name620200616
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
2487e6ef-d419-42fc-aaf8-7acc805d2370Product name220170718
e071c814-e5e7-e7ed-ec76-428765d9c66bProduct name220151120
93148e06-b8d7-4e6c-853e-62f807d17fbbProduct name120151014
dbb00be6-fb1c-4b0a-a770-31f7e05e247eProduct name120150316
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21922-009-092025-01-30C16284748780-12cef2736-aa0c-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use DICLOFENAC SODIUM TOPICAL GEL safely and effectively. See full prescribing information for DICLOFENAC SODIUM TOPICAL GEL. DICLOFENAC SODIUM topical gel, 1% for topical use only Initial U.S. Approval: 1988

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21922-009-09Diclofenac Sodium100 g in 1 TUBEGEL1002
21922-009-09Diclofenac Sodium1 in 1 CARTONGEL12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21922-009DICLOFENAC SODIUM (DICLOFENAC SODIUM TOPICAL GEL, 1%,) GEL [ENCUBE ETHICALS PRIVATE LIMITED]2Legacy NDC, 2 package rows20200214_cb24dd04-d65f-4f1b-9635-e04d62b059f7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855633diclofenac sodium 1 % Topical GelPSNaee20924-79ab-400e-b9b6-4189789146547
855633diclofenac sodium 0.01 MG/MG Topical GelSCDaee20924-79ab-400e-b9b6-4189789146547
855633diclofenac sodium 1 % Topical GelSYaee20924-79ab-400e-b9b6-4189789146547
855633diclofenac sodium 1 % Topical GelPSN03abebd6-426a-9d05-3dff-1964773894306
855633diclofenac sodium 0.01 MG/MG Topical GelSCD03abebd6-426a-9d05-3dff-1964773894306
855633diclofenac sodium 1 % Topical GelSY03abebd6-426a-9d05-3dff-1964773894306
855633diclofenac sodium 1 % Topical GelPSNad193f94-f8d0-8482-e053-2995a90a35a44
855633diclofenac sodium 0.01 MG/MG Topical GelSCDad193f94-f8d0-8482-e053-2995a90a35a44
855633diclofenac sodium 1 % Topical GelSYad193f94-f8d0-8482-e053-2995a90a35a44
855633diclofenac sodium 1 % Topical GelPSNfce9b3eb-ae79-a090-e053-6294a90ad20e3
855633diclofenac sodium 0.01 MG/MG Topical GelSCDfce9b3eb-ae79-a090-e053-6294a90ad20e3
855633diclofenac sodium 1 % Topical GelSYfce9b3eb-ae79-a090-e053-6294a90ad20e3
855633diclofenac sodium 1 % Topical GelPSN0ed15330-5883-4e70-a03c-2823b7c8a86e2
855633diclofenac sodium 1 % Topical GelPSN4500bf3c-394b-4397-8751-8dac2097fc412
855633diclofenac sodium 1 % Topical GelPSNcb24dd04-d65f-4f1b-9635-e04d62b059f72
855633diclofenac sodium 1 % Topical GelPSN2e70d8e9-9678-2d51-e063-6294a90aca642
855633diclofenac sodium 0.01 MG/MG Topical GelSCD0ed15330-5883-4e70-a03c-2823b7c8a86e2
855633diclofenac sodium 0.01 MG/MG Topical GelSCDcb24dd04-d65f-4f1b-9635-e04d62b059f72
855633diclofenac sodium 0.01 MG/MG Topical GelSCD4500bf3c-394b-4397-8751-8dac2097fc412
855633diclofenac sodium 0.01 MG/MG Topical GelSCD2e70d8e9-9678-2d51-e063-6294a90aca642
855633diclofenac sodium 1 % Topical GelSY0ed15330-5883-4e70-a03c-2823b7c8a86e2
855633diclofenac sodium 1 % Topical GelSYcb24dd04-d65f-4f1b-9635-e04d62b059f72
855633diclofenac sodium 1 % Topical GelSY4500bf3c-394b-4397-8751-8dac2097fc412
855633diclofenac sodium 1 % Topical GelSY2e70d8e9-9678-2d51-e063-6294a90aca642
855633diclofenac sodium 1 % Topical GelPSN988abe66-0b3b-4c13-87b4-adc913227fc51
855633diclofenac sodium 1 % Topical GelPSN1f21022e-7d86-438f-a49e-0a787f499cc41
855633diclofenac sodium 1 % Topical GelPSN828b5de2-77a7-4893-ab47-dffc8ea736931
855633diclofenac sodium 1 % Topical GelPSN7e98952e-9b95-4296-9c23-c0ff4b82b2b71
855633diclofenac sodium 1 % Topical GelPSN3e63324b-e761-9367-e063-6394a90a29811
1010057lidocaine HCl 5 % Topical GelPSN3e63324b-e761-9367-e063-6394a90a29811
855633diclofenac sodium 0.01 MG/MG Topical GelSCD3e63324b-e761-9367-e063-6394a90a29811
855633diclofenac sodium 0.01 MG/MG Topical GelSCD988abe66-0b3b-4c13-87b4-adc913227fc51
855633diclofenac sodium 0.01 MG/MG Topical GelSCD828b5de2-77a7-4893-ab47-dffc8ea736931
855633diclofenac sodium 0.01 MG/MG Topical GelSCD7e98952e-9b95-4296-9c23-c0ff4b82b2b71
855633diclofenac sodium 0.01 MG/MG Topical GelSCD1f21022e-7d86-438f-a49e-0a787f499cc41
1010057lidocaine hydrochloride 0.05 MG/MG Topical GelSCD3e63324b-e761-9367-e063-6394a90a29811
855633diclofenac sodium 1 % Topical GelSY828b5de2-77a7-4893-ab47-dffc8ea736931
855633diclofenac sodium 1 % Topical GelSY988abe66-0b3b-4c13-87b4-adc913227fc51
855633diclofenac sodium 1 % Topical GelSY1f21022e-7d86-438f-a49e-0a787f499cc41
855633diclofenac sodium 1 % Topical GelSY7e98952e-9b95-4296-9c23-c0ff4b82b2b71
855633diclofenac sodium 1 % Topical GelSY3e63324b-e761-9367-e063-6394a90a29811
1010057lidocaine hydrochloride 5 % Topical GelSY3e63324b-e761-9367-e063-6394a90a29811

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
21922-009-09219220009091 TUBE in 1 CARTON (21922-009-09) > 100 g in 1 TUBE1 tube2020-01-300000-00-00NoNoCurrent