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 RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
205285Internal RxNorm lookup
855633Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
91d62919-c4bb-4dd0-af23-c5183bc53d00Available on FDA.report

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72835-602-02EA - Each72835-6026ad14dec-2f67-4231-a64d-6f18f08c226c12023-03-13

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LeflunicloLEFLUNOMIDE AND DICLOFENAC SODIUM GELV2 Pharma, LLC91d62919-c4bb-4dd0-af23-c5183bc53d002023-03-29Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (product): 72835-602

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