FDA.reportPublic FDA data

Famotidine

Product NDC
0363-5300
11-digit product format
003635300
Labeler code
0363
Product ID
0363-5300_d8272405-523e-4572-ac4c-721ef990cf51
Type
HUMAN OTC DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
WALGREEN CO.
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
0363-5300-14Famotidine50 in 1 BOTTLETABLET, FILM COATED508
0363-5300-14Famotidine1 in 1 CARTONTABLET, FILM COATED18
0363-5300-34Famotidine1 in 1 CARTONTABLET, FILM COATED18
0363-5300-34Famotidine200 in 1 BOTTLETABLET, FILM COATED2008
0363-5300-47Famotidine1 in 1 CARTONTABLET, FILM COATED18
0363-5300-47Famotidine75 in 1 BOTTLETABLET, FILM COATED758
0363-5300-50Famotidine1 in 1 CARTONTABLET, FILM COATED18
0363-5300-50Famotidine85 in 1 BOTTLETABLET, FILM COATED858
0363-5300-53Famotidine25 in 1 BOTTLETABLET, FILM COATED258
0363-5300-53Famotidine1 in 1 CARTONTABLET, FILM COATED18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-5300FAMOTIDINE TABLET, FILM COATED [WALGREEN CO.]8Current NDC, Legacy NDC, 10 package rows20250425_2766ffe7-2f1c-48c8-8f67-0a2819dcc3be.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310273famotidine 20 MG Oral TabletPSN2766ffe7-2f1c-48c8-8f67-0a2819dcc3be8
310273famotidine 20 MG Oral TabletSCD2766ffe7-2f1c-48c8-8f67-0a2819dcc3be8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-5300-14003635300141 BOTTLE in 1 CARTON (0363-5300-14) / 50 TABLET, FILM COATED in 1 BOTTLE1 bottle2016-04-260000-00-00NoNoCurrent
0363-5300-34003635300341 BOTTLE in 1 CARTON (0363-5300-34) / 200 TABLET, FILM COATED in 1 BOTTLE1 bottle2022-07-260000-00-00NoNoCurrent
0363-5300-47003635300471 BOTTLE in 1 CARTON (0363-5300-47) / 75 TABLET, FILM COATED in 1 BOTTLE1 bottle2024-02-17NoNoCurrent
0363-5300-50003635300501 BOTTLE in 1 CARTON (0363-5300-50) / 85 TABLET, FILM COATED in 1 BOTTLE1 bottle2016-04-260000-00-00NoNoCurrent
0363-5300-53003635300531 BOTTLE in 1 CARTON (0363-5300-53) / 25 TABLET, FILM COATED in 1 BOTTLE1 bottle2016-04-260000-00-00NoNoCurrent