Leflunomide

Product NDC
70518-3240
11-digit product format
705183240
Labeler code
70518
Product ID
70518-3240_ceb5a939-1fe3-42a0-e053-2995a90a2bf2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Leflunomide
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA212453
Marketing category
ANDA
Marketing start
2021-10-13
Marketing end
0000-00-00
Substance
LEFLUNOMIDE
Active strength
20 mg/1
Pharmacologic classes
Antirheumatic Agent [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-3240-02023-03-23C16284748780-1f386c649-deed-0266-e053-dadaa90a7c1a013bd673-3694-48a8-899b-de29faa07c9b
70518-3240-02023-01-30C16284748780-1f386c649-deed-0266-e053-dadaa90a7c1a013bd673-3694-48a8-899b-de29faa07c9b

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3240-07051832400030 POUCH in 1 BOX (70518-3240-0) > 1 TABLET in 1 POUCH (70518-3240-1) 30 pouch2021-10-130000-00-00NoNoCurrent