FDA.reportPublic FDA data

Famotidine

Product NDC
58602-705
11-digit product format
586020705
Labeler code
58602
Product ID
58602-705_83d5769e-ef9c-4ce5-afd5-a2dd7496274a
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
10 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
FAMOTIDINE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5QZO15J2Z8
Rxcui199047

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
58602-705-03Famotidine10 in 1 BLISTER PACKTABLET, FILM COATED1013
58602-705-09Famotidine3 in 1 CARTONTABLET, FILM COATED313
58602-705-12Famotidine4 in 1 CARTONTABLET, FILM COATED413
58602-705-14Famotidine1 in 1 CARTONTABLET, FILM COATED113
58602-705-14Famotidine50 in 1 BOTTLETABLET, FILM COATED5013
58602-705-15Famotidine1 in 1 CARTONTABLET, FILM COATED113
58602-705-15Famotidine60 in 1 BOTTLETABLET, FILM COATED6013
58602-705-19Famotidine1 in 1 CARTONTABLET, FILM COATED113
58602-705-19Famotidine90 in 1 BOTTLETABLET, FILM COATED9013
58602-705-32Famotidine180 in 1 BOTTLETABLET, FILM COATED18013
58602-705-32Famotidine1 in 1 CARTONTABLET, FILM COATED113
58602-705-34Famotidine1 in 1 CARTONTABLET, FILM COATED113
58602-705-34Famotidine200 in 1 BOTTLETABLET, FILM COATED20013
58602-705-39Famotidine1 in 1 CARTONTABLET, FILM COATED113
58602-705-39Famotidine365 in 1 BOTTLETABLET, FILM COATED36513
58602-705-40Famotidine500 in 1 BOTTLETABLET, FILM COATED50013
58602-705-40Famotidine1 in 1 CARTONTABLET, FILM COATED113
58602-705-41Famotidine1000 in 1 BOTTLETABLET, FILM COATED100013
58602-705-41Famotidine1 in 1 CARTONTABLET, FILM COATED113
58602-705-44Famotidine1 in 1 CARTONTABLET, FILM COATED113
58602-705-44Famotidine400 in 1 BOTTLETABLET, FILM COATED40013
58602-705-84Famotidine1 in 1 CARTONTABLET, FILM COATED113
58602-705-84Famotidine30 in 1 BOTTLETABLET, FILM COATED3013
58602-705-88Famotidine750 in 1 BOTTLETABLET, FILM COATED75013
58602-705-88Famotidine1 in 1 CARTONTABLET, FILM COATED113
58602-705-93Famotidine90 in 1 BOTTLETABLET, FILM COATED9013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58602-705-15EA - Each58602-705f2623aa0-791a-40af-ac34-8254bc52f7c912022-02-07
58602-705-19EA - Each58602-7056402435b-39ad-40bf-aadd-6feba559e09812021-04-08
58602-705-84EA - Each58602-70571d62bb7-0854-4a7b-9efa-f26c2d6522d612020-07-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58602-705FAMOTIDINE TABLET, FILM COATED [AUROHEALTH LLC]13Current NDC, Legacy NDC, 26 package rows20250321_756c7234-6a63-4b1b-be36-2b1ed09e67a0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199047famotidine 10 MG Oral TabletPSN756c7234-6a63-4b1b-be36-2b1ed09e67a013
199047famotidine 10 MG Oral TabletSCD756c7234-6a63-4b1b-be36-2b1ed09e67a013
199047famotidine 10 MG Oral TabletPSN68120de1-fd9a-4f93-b218-d99ed7c5080a2
199047famotidine 10 MG Oral TabletSCD68120de1-fd9a-4f93-b218-d99ed7c5080a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58602-705-035860207050310 in 1 BLISTER PACKHistorical
58602-705-09586020705093 BLISTER PACK in 1 CARTON (58602-705-09) / 10 TABLET, FILM COATED in 1 BLISTER PACK (58602-705-03) 3 blister pack2016-04-260000-00-00NoNoCurrent
58602-705-12586020705124 BLISTER PACK in 1 CARTON (58602-705-12) / 10 TABLET, FILM COATED in 1 BLISTER PACK (58602-705-03) 4 blister pack2016-04-260000-00-00NoNoCurrent
58602-705-14586020705141 BOTTLE in 1 CARTON (58602-705-14) / 50 TABLET, FILM COATED in 1 BOTTLE1 bottle2019-12-210000-00-00NoNoCurrent
58602-705-15586020705151 BOTTLE in 1 CARTON (58602-705-15) / 60 TABLET, FILM COATED in 1 BOTTLE1 bottle2016-04-260000-00-00NoNoCurrent
58602-705-19586020705191 BOTTLE in 1 CARTON (58602-705-19) / 90 TABLET, FILM COATED in 1 BOTTLE1 bottle2016-04-260000-00-00NoNoCurrent
58602-705-32586020705321 BOTTLE in 1 CARTON (58602-705-32) / 180 TABLET, FILM COATED in 1 BOTTLE1 bottle2022-02-180000-00-00NoNoCurrent
58602-705-34586020705341 BOTTLE in 1 CARTON (58602-705-34) / 200 TABLET, FILM COATED in 1 BOTTLE1 bottle2020-07-220000-00-00NoNoCurrent
58602-705-39586020705391 BOTTLE in 1 CARTON (58602-705-39) / 365 TABLET, FILM COATED in 1 BOTTLE1 bottle2020-07-220000-00-00NoNoCurrent
58602-705-40586020705401 BOTTLE in 1 CARTON (58602-705-40) / 500 TABLET, FILM COATED in 1 BOTTLE1 bottle2020-07-220000-00-00NoNoCurrent
58602-705-41586020705411 BOTTLE in 1 CARTON (58602-705-41) / 1000 TABLET, FILM COATED in 1 BOTTLE1 bottle2020-09-040000-00-00NoNoCurrent
58602-705-44586020705441 BOTTLE in 1 CARTON (58602-705-44) / 400 TABLET, FILM COATED in 1 BOTTLE1 bottle2020-07-220000-00-00NoNoCurrent
58602-705-84586020705841 BOTTLE in 1 CARTON (58602-705-84) / 30 TABLET, FILM COATED in 1 BOTTLE1 bottle2019-05-130000-00-00NoNoCurrent
58602-705-88586020705881 BOTTLE in 1 CARTON (58602-705-88) / 750 TABLET, FILM COATED in 1 BOTTLE1 bottle2020-07-220000-00-00NoNoCurrent
58602-705-935860207059390 TABLET, FILM COATED in 1 BOTTLE (58602-705-93) 2016-04-260000-00-00NoNoCurrent