DICLOFENAC SODIUM

Product NDC
0574-0167
11-digit product format
005740167
Labeler code
0574
Product ID
0574-0167_ed2d9809-171d-4d59-8884-6561ffcf398d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diclofenac sodium
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Padagis US LLC
Application
NDA204623
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2022-11-22
Marketing end
0000-00-00
Substance
DICLOFENAC SODIUM
Active strength
20 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
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
8d368a34-1453-43ea-828d-0dbcd72b8794Product name820210622
d6bab9d2-edce-a213-4796-226ab15472c3Product name620200616
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
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
0574-0167-12GM - Gram0574-0167ebcba1cf-ca34-44c7-a493-cc87906ea3cf12022-12-07

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1487074diclofenac sodium 2 % Topical SolutionPSN0026d74b-7a6b-66ce-e063-6294a90a0ffa1
1487074diclofenac sodium 20 MG/ML Topical SolutionSCD0026d74b-7a6b-66ce-e063-6294a90a0ffa1
1487074diclofenac sodium 2 % Topical SolutionSY0026d74b-7a6b-66ce-e063-6294a90a0ffa1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0574-0167-12005740167121 BOTTLE in 1 CARTON (0574-0167-12) > 112 g in 1 BOTTLE1 bottle2022-11-220000-00-00NoNoCurrent