Famotidine

Product NDC
58118-0859
11-digit product format
581180859
Labeler code
58118
Product ID
58118-0859_b025952e-f645-48e5-e053-2995a90af83b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Clinical Solutions Wholesale, LLC
Application
ANDA206530
Marketing category
ANDA
Marketing start
2017-07-06
Marketing end
0000-00-00
Substance
FAMOTIDINE
Active strength
20 mg/1
Pharmacologic classes
Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58118-0859-82024-01-30C16284748780-11030e365-3971-111a-e063-dadaa90a10e2b80a4906-01a4-4815-8f8f-e77e64d21efb

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58118-0859FAMOTIDINE TABLET, FILM COATED [CLINICAL SOLUTIONS WHOLESALE, LLC]6Legacy NDC20200926_b80a4906-01a4-4815-8f8f-e77e64d21efb.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
58118-0859-85811808590830 TABLET, FILM COATED in 1 BLISTER PACK (58118-0859-8) 2017-07-060000-00-00NoNoCurrent