Lefluniclo

Product NDC
72835-602
11-digit product format
728350602
Labeler code
72835
Product ID
72835-602_ad348698-0878-46dc-a453-06abf5815929
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Leflunomide and Diclofenac Sodium Gel
Dosage form
KIT
Labeler
V2 Pharma, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2023-01-11
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Lefluniclo
Listing expiration
2026-12-31

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui205285, 855633

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
07b45089-afbe-518f-59f0-bf5b3c5b5d4eProduct name420210927
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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0113-1189-01Lefluniclo100 g in 1 TUBEGEL100 g10 mg in 1g8
70748-130-06Lefluniclo1 in 1 CARTONTABLET, FILM COATED20 mg8
70748-130-06Lefluniclo30 in 1 BOTTLETABLET, FILM COATED3020 mg8
72835-602-02Lefluniclo1 in 1 CARTONKIT18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72835-602LEFLUNICLO (LEFLUNOMIDE AND DICLOFENAC SODIUM GEL) KIT [V2 PHARMA, LLC]8Current NDC, 4 package rows20230331_91d62919-c4bb-4dd0-af23-c5183bc53d00.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855633diclofenac sodium 1 % Topical GelPSN91d62919-c4bb-4dd0-af23-c5183bc53d008
205285leflunomide 20 MG Oral TabletPSN91d62919-c4bb-4dd0-af23-c5183bc53d008
855633diclofenac sodium 0.01 MG/MG Topical GelSCD91d62919-c4bb-4dd0-af23-c5183bc53d008
205285leflunomide 20 MG Oral TabletSCD91d62919-c4bb-4dd0-af23-c5183bc53d008
855633diclofenac sodium 1 % Topical GelSY91d62919-c4bb-4dd0-af23-c5183bc53d008

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0113-1189-0100113118901100 g in 1 TUBE100 gHistorical
70748-130-06707480130061 in 1 CARTONHistorical
72835-602-02728350602021 KIT in 1 CARTON (72835-602-02) * 1 BOTTLE in 1 CARTON (70748-130-06) / 30 TABLET, FILM COATED in 1 BOTTLE * 100 g in 1 TUBE (0113-1189-01) 1 kit2023-01-11NoNoCurrent