FDA.reportPublic FDA data

DICLOFENAC SODIUM

Product NDC
50436-0355
11-digit product format
504360355
Labeler code
50436
Product ID
50436-0355_d3859122-1117-4869-b4a7-a605a1702e9d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diclofenac sodium
Dosage form
GEL
Route
TOPICAL
Labeler
Unit Dose Services
Application
ANDA208301
Marketing category
ANDA
Marketing start
2016-09-13
Marketing end
0000-00-00
Substance
DICLOFENAC SODIUM
Active strength
30 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
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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50436-0355-12021-01-29C16284748780-1ba0f9c33-41b5-a910-e053-dadaa90a0b85DICLOFENAC SODIUM GEL, 3%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-0355-1DICLOFENAC SODIUM1 g in 1 CARTONGEL12
50436-0355-1DICLOFENAC SODIUM100 in 1 TUBEGEL1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50436-0355-1GM - Gram50436-0355f5fce5d2-4d6f-472d-b72a-37271e1c837112018-06-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-0355DICLOFENAC SODIUM GEL [UNIT DOSE SERVICES]2Legacy NDC, 2 package rows20180518_1bb676f9-243a-4ae7-b4db-815608e01739.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855642diclofenac sodium 3 % Topical GelPSN1bb676f9-243a-4ae7-b4db-815608e017392
855642diclofenac sodium 0.03 MG/MG Topical GelSCD1bb676f9-243a-4ae7-b4db-815608e017392
855642diclofenac sodium 3 % Topical GelSY1bb676f9-243a-4ae7-b4db-815608e017392

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
50436-0355-1504360355011 g in 1 CARTON1 gHistorical