FDA.reportPublic FDA data

Famotidine

Product NDC
50090-4389
11-digit product format
500904389
Labeler code
50090
Product ID
50090-4389_3f84925f-c598-4513-9e91-9b123c4edc3d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA075511
Marketing category
ANDA
Marketing start
2001-04-16
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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
396bde5c-c78e-2f8b-ab1f-2ee6ba32bcaeProduct name720260317
1e73f975-1ce7-705e-2bcf-788b1b5e24baProduct name520251124
cf645750-2e70-f6e1-c05a-a52847def5ddProduct name920250312
4fdc761c-585e-054b-8ebe-86130a26e4c1Product name220221205
fc2e1e31-353a-2c24-a4b4-fcf93bf7e38eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-4389-02023-01-30C16284748780-1f386c64a-2372-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use FAMOTIDINE TABLETS safely and effectively. See full prescribing information for FAMOTIDINE TABLETS . FAMOTIDINE tablets, for oral use Initial U.S. Approval: 1986
50090-4389-12023-01-30C16284748780-1f386c64a-2372-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use FAMOTIDINE TABLETS safely and effectively. See full prescribing information for FAMOTIDINE TABLETS . FAMOTIDINE tablets, for oral use Initial U.S. Approval: 1986

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4389-0Famotidine30 in 1 BOTTLETABLET, FILM COATED301
50090-4389-1Famotidine30 in 1 BOTTLETABLET, FILM COATED301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4389FAMOTIDINE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]1Legacy NDC, 2 package rows20200822_492241f8-9dad-453a-a996-50ce67d0812a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310273famotidine 20 MG Oral TabletPSN492241f8-9dad-453a-a996-50ce67d0812a1
310273famotidine 20 MG Oral TabletSCD492241f8-9dad-453a-a996-50ce67d0812a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4389-05009043890030 TABLET, FILM COATED in 1 BOTTLE (50090-4389-0) 2019-06-260000-00-00NoNoCurrent
50090-4389-15009043890130 TABLET, FILM COATED in 1 BOTTLE (50090-4389-1) 2019-06-260000-00-00NoNoCurrent