FDA.reportPublic FDA data

berkley and jensen famotidine

Product NDC
68391-300
11-digit product format
683910300
Labeler code
68391
Product ID
68391-300_8459c675-5144-445c-afdb-c09b445fc14b
Type
HUMAN OTC DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
BJWC
Application
ANDA077351
Marketing category
ANDA
Marketing start
2013-12-09
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
berkley and jensen famotidine
Listing expiration
2027-12-31

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
68391-300-05berkley and jensen famotidine125 in 1 BOTTLETABLET, FILM COATED12511
68391-300-78berkley and jensen famotidine100 in 1 BOTTLETABLET, FILM COATED10011
68391-300-82berkley and jensen famotidine2 in 1 PACKAGETABLET, FILM COATED211
68391-300-82berkley and jensen famotidine100 in 1 BOTTLETABLET, FILM COATED10011
68391-300-85berkley and jensen famotidine2 in 1 PACKAGETABLET, FILM COATED211

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FAMOTIDINEACTIVE INGREDIENT5QZO15J2Z8BERKLEY AND JENSEN FAMOTIDINE (FAMOTIDINE) TABLET [BJWC]2
FAMOTIDINEACTIVE MOIETY5QZO15J2Z8BERKLEY AND JENSEN FAMOTIDINE (FAMOTIDINE) TABLET [BJWC]2
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZBERKLEY AND JENSEN FAMOTIDINE (FAMOTIDINE) TABLET [BJWC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBERKLEY AND JENSEN FAMOTIDINE (FAMOTIDINE) TABLET [BJWC]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48BERKLEY AND JENSEN FAMOTIDINE (FAMOTIDINE) TABLET [BJWC]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XBERKLEY AND JENSEN FAMOTIDINE (FAMOTIDINE) TABLET [BJWC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BERKLEY AND JENSEN FAMOTIDINE (FAMOTIDINE) TABLET [BJWC]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ABERKLEY AND JENSEN FAMOTIDINE (FAMOTIDINE) TABLET [BJWC]2
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990BERKLEY AND JENSEN FAMOTIDINE (FAMOTIDINE) TABLET [BJWC]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BERKLEY AND JENSEN FAMOTIDINE (FAMOTIDINE) TABLET [BJWC]2
TALCINACTIVE INGREDIENT7SEV7J4R1UBERKLEY AND JENSEN FAMOTIDINE (FAMOTIDINE) TABLET [BJWC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBERKLEY AND JENSEN FAMOTIDINE (FAMOTIDINE) TABLET [BJWC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68391-300BERKLEY AND JENSEN FAMOTIDINE (FAMOTIDINE) TABLET, FILM COATED [BJWC]9Current NDC, Legacy NDC, 5 package rows20250212_93c857e4-72b3-433e-ae6f-281cd57e3996.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310273famotidine 20 MG Oral TabletPSN93c857e4-72b3-433e-ae6f-281cd57e399611
310273famotidine 20 MG Oral TabletSCD93c857e4-72b3-433e-ae6f-281cd57e399611

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68391-300-0568391030005125 in 1 BOTTLEHistorical
68391-300-7868391030078100 TABLET, FILM COATED in 1 BOTTLE (68391-300-78) 2013-12-090000-00-00NoNoCurrent
68391-300-82683910300822 BOTTLE in 1 PACKAGE (68391-300-82) / 100 TABLET, FILM COATED in 1 BOTTLE2 bottle2013-12-090000-00-00NoNoCurrent
68391-300-85683910300852 BOTTLE in 1 PACKAGE (68391-300-85) / 125 TABLET, FILM COATED in 1 BOTTLE (68391-300-05) 2 bottle2025-09-04NoNoCurrent