FDA.reportPublic FDA data

Diclofenac Sodium

Product NDC
69097-524
11-digit product format
690970524
Labeler code
69097
Product ID
69097-524_1d880e10-e221-4622-b6ed-c8f73e9bdde4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Sodium
Dosage form
GEL
Route
TOPICAL
Labeler
Cipla USA Inc.
Application
ANDA209903
Marketing category
ANDA
Marketing start
2018-08-16
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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69097-524-44GM - Gram69097-524402a48e5-4f7d-4604-9bb9-6d523827570a12018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69097-524DICLOFENAC SODIUM GEL [CIPLA USA INC.]11Legacy NDC20221226_8d7c243b-07a6-446a-8e05-4d14d6d19394.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855633diclofenac sodium 1 % Topical GelPSN203f96bb-ae63-475c-b7a6-03c0dbc435979
855633diclofenac sodium 0.01 MG/MG Topical GelSCD203f96bb-ae63-475c-b7a6-03c0dbc435979
855633diclofenac sodium 1 % Topical GelSY203f96bb-ae63-475c-b7a6-03c0dbc435979
855633diclofenac sodium 1 % Topical GelPSN51756947-e802-4b4d-883e-fd6f22e9a7258
855633diclofenac sodium 0.01 MG/MG Topical GelSCD51756947-e802-4b4d-883e-fd6f22e9a7258
855633diclofenac sodium 1 % Topical GelSY51756947-e802-4b4d-883e-fd6f22e9a7258
855633diclofenac sodium 1 % Topical GelPSN12e1f808-9f24-4f6d-b5bc-12ce0059ab7a4
855633diclofenac sodium 0.01 MG/MG Topical GelSCD12e1f808-9f24-4f6d-b5bc-12ce0059ab7a4
855633diclofenac sodium 1 % Topical GelSY12e1f808-9f24-4f6d-b5bc-12ce0059ab7a4
855633diclofenac sodium 1 % Topical GelPSN200c2800-a703-e138-e063-6394a90acc091
855633diclofenac sodium 1 % Topical GelPSN95fc34de-adfb-4797-95e3-6a3539c1636e1
855633diclofenac sodium 0.01 MG/MG Topical GelSCD200c2800-a703-e138-e063-6394a90acc091
855633diclofenac sodium 0.01 MG/MG Topical GelSCD95fc34de-adfb-4797-95e3-6a3539c1636e1
855633diclofenac sodium 1 % Topical GelSY200c2800-a703-e138-e063-6394a90acc091
855633diclofenac sodium 1 % Topical GelSY95fc34de-adfb-4797-95e3-6a3539c1636e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69097-524-44690970524441 TUBE in 1 CARTON (69097-524-44) > 100 g in 1 TUBE1 tube2018-08-160000-00-00NoNoCurrent