FDA.reportPublic FDA data

Famotidine

Product NDC
58602-706
11-digit product format
586020706
Labeler code
58602
Product ID
58602-706_4329025b-5cdd-4287-955f-028e6aca198c
Type
HUMAN OTC DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurohealth LLC
Application
ANDA206531
Marketing category
ANDA
Marketing start
2016-04-26
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FAMOTIDINE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5QZO15J2Z8
Rxcui310273

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58602-706-14Famotidine50 in 1 BOTTLETABLET, FILM COATED5014
58602-706-14Famotidine1 in 1 CARTONTABLET, FILM COATED114
58602-706-15Famotidine8 in 1 BLISTER PACKTABLET, FILM COATED814
58602-706-15Famotidine2 in 1 CARTONTABLET, FILM COATED214
58602-706-16Famotidine65 in 1 BOTTLETABLET, FILM COATED6514
58602-706-16Famotidine1 in 1 CARTONTABLET, FILM COATED114
58602-706-18Famotidine1 in 1 CARTONTABLET, FILM COATED114
58602-706-18Famotidine80 in 1 BOTTLETABLET, FILM COATED8014
58602-706-19Famotidine90 in 1 BOTTLETABLET, FILM COATED9014
58602-706-19Famotidine1 in 1 CARTONTABLET, FILM COATED114
58602-706-21Famotidine1 in 1 CARTONTABLET, FILM COATED114
58602-706-21Famotidine100 in 1 BOTTLETABLET, FILM COATED10014
58602-706-34Famotidine200 in 1 BOTTLETABLET, FILM COATED20014
58602-706-34Famotidine1 in 1 CARTONTABLET, FILM COATED114
58602-706-39Famotidine1 in 1 CARTONTABLET, FILM COATED114
58602-706-39Famotidine365 in 1 BOTTLETABLET, FILM COATED36514
58602-706-40Famotidine1 in 1 CARTONTABLET, FILM COATED114
58602-706-40Famotidine500 in 1 BOTTLETABLET, FILM COATED50014
58602-706-41Famotidine1000 in 1 BOTTLETABLET, FILM COATED100014
58602-706-44Famotidine1 in 1 CARTONTABLET, FILM COATED114
58602-706-44Famotidine400 in 1 BOTTLETABLET, FILM COATED40014
58602-706-47Famotidine1 in 1 CARTONTABLET, FILM COATED114
58602-706-47Famotidine75 in 1 BOTTLETABLET, FILM COATED7514
58602-706-50Famotidine85 in 1 BOTTLETABLET, FILM COATED8514
58602-706-50Famotidine1 in 1 CARTONTABLET, FILM COATED114
58602-706-53Famotidine1 in 1 CARTONTABLET, FILM COATED114
58602-706-53Famotidine25 in 1 BOTTLETABLET, FILM COATED2514
58602-706-54Famotidine70 in 1 BOTTLETABLET, FILM COATED7014
58602-706-54Famotidine1 in 1 CARTONTABLET, FILM COATED114
58602-706-56Famotidine35 in 1 BOTTLETABLET, FILM COATED3514
58602-706-56Famotidine1 in 1 CARTONTABLET, FILM COATED114
58602-706-60Famotidine5 in 1 BLISTER PACKTABLET, FILM COATED514
58602-706-62Famotidine5 in 1 CARTONTABLET, FILM COATED514
58602-706-79Famotidine1 in 1 CARTONTABLET, FILM COATED114
58602-706-79Famotidine8 in 1 BLISTER PACKTABLET, FILM COATED814
58602-706-88Famotidine750 in 1 BOTTLETABLET, FILM COATED75014
58602-706-94Famotidine100 in 1 BOTTLETABLET, FILM COATED10014

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58602-706FAMOTIDINE TABLET, FILM COATED [AUROHEALTH LLC]14Current NDC, Legacy NDC, 37 package rows20250425_f2b911c7-ce24-4d3d-8fb6-c34980191f40.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310273famotidine 20 MG Oral TabletPSNf2b911c7-ce24-4d3d-8fb6-c34980191f4014
310273famotidine 20 MG Oral TabletSCDf2b911c7-ce24-4d3d-8fb6-c34980191f4014
310273famotidine 20 MG Oral TabletPSN787724dc-0b4b-4973-852e-c7d722f637b01
310273famotidine 20 MG Oral TabletSCD787724dc-0b4b-4973-852e-c7d722f637b01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58602-706-14586020706141 BOTTLE in 1 CARTON (58602-706-14) / 50 TABLET, FILM COATED in 1 BOTTLE1 bottle2016-04-260000-00-00NoNoCurrent
58602-706-15586020706152 BLISTER PACK in 1 CARTON (58602-706-15) / 8 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack2020-02-240000-00-00NoNoCurrent
58602-706-16586020706161 BOTTLE in 1 CARTON (58602-706-16) / 65 TABLET, FILM COATED in 1 BOTTLE1 bottle2016-04-260000-00-00NoNoCurrent
58602-706-18586020706181 BOTTLE in 1 CARTON (58602-706-18) / 80 TABLET, FILM COATED in 1 BOTTLE1 bottle2016-04-260000-00-00NoNoCurrent
58602-706-19586020706191 BOTTLE in 1 CARTON (58602-706-19) / 90 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-01-080000-00-00NoNoCurrent
58602-706-21586020706211 BOTTLE in 1 CARTON (58602-706-21) / 100 TABLET, FILM COATED in 1 BOTTLE1 bottle2016-04-260000-00-00NoNoCurrent
58602-706-34586020706341 BOTTLE in 1 CARTON (58602-706-34) / 200 TABLET, FILM COATED in 1 BOTTLE1 bottle2020-07-220000-00-00NoNoCurrent
58602-706-39586020706391 BOTTLE in 1 CARTON (58602-706-39) / 365 TABLET, FILM COATED in 1 BOTTLE1 bottle2020-07-220000-00-00NoNoCurrent
58602-706-40586020706401 BOTTLE in 1 CARTON (58602-706-40) / 500 TABLET, FILM COATED in 1 BOTTLE1 bottle2020-07-220000-00-00NoNoCurrent
58602-706-41586020706411000 TABLET, FILM COATED in 1 BOTTLE (58602-706-41) 2020-09-040000-00-00NoNoCurrent
58602-706-44586020706441 BOTTLE in 1 CARTON (58602-706-44) / 400 TABLET, FILM COATED in 1 BOTTLE1 bottle2020-07-220000-00-00NoNoCurrent
58602-706-47586020706471 BOTTLE in 1 CARTON (58602-706-47) / 75 TABLET, FILM COATED in 1 BOTTLE1 bottle2016-04-260000-00-00NoNoCurrent
58602-706-50586020706501 BOTTLE in 1 CARTON (58602-706-50) / 85 TABLET, FILM COATED in 1 BOTTLE1 bottle2016-04-260000-00-00NoNoCurrent
58602-706-53586020706531 BOTTLE in 1 CARTON (58602-706-53) / 25 TABLET, FILM COATED in 1 BOTTLE1 bottle2016-04-260000-00-00NoNoCurrent
58602-706-54586020706541 BOTTLE in 1 CARTON (58602-706-54) / 70 TABLET, FILM COATED in 1 BOTTLE1 bottle2016-04-260000-00-00NoNoCurrent
58602-706-56586020706561 BOTTLE in 1 CARTON (58602-706-56) / 35 TABLET, FILM COATED in 1 BOTTLE1 bottle2016-04-260000-00-00NoNoCurrent
58602-706-60586020706605 in 1 BLISTER PACKHistorical
58602-706-62586020706625 BLISTER PACK in 1 CARTON (58602-706-62) / 5 TABLET, FILM COATED in 1 BLISTER PACK (58602-706-60) 5 blister pack2016-04-260000-00-00NoNoCurrent
58602-706-79586020706791 BLISTER PACK in 1 CARTON (58602-706-79) / 8 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2016-04-260000-00-00NoNoCurrent
58602-706-8858602070688750 TABLET, FILM COATED in 1 BOTTLE (58602-706-88) 2020-07-220000-00-00NoNoCurrent
58602-706-9458602070694100 TABLET, FILM COATED in 1 BOTTLE (58602-706-94) 2016-04-260000-00-00NoNoCurrent