FDA.reportPublic FDA data

dg health heartburn prevention

Product NDC
55910-194
11-digit product format
559100194
Labeler code
55910
Product ID
55910-194_c43bc6c6-105f-4e21-b6ec-11e87ce0e847
Type
HUMAN OTC DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Dolgencorp Inc
Application
ANDA077351
Marketing category
ANDA
Marketing start
2010-02-14
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
dg health heartburn prevention
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
55910-194-02dg health heartburn prevention25 in 1 CARTONTABLET, FILM COATED2513
55910-194-02dg health heartburn prevention1 in 1 BLISTER PACKTABLET, FILM COATED113
55910-194-39dg health heartburn prevention30 in 1 CARTONTABLET, FILM COATED3013
55910-194-39dg health heartburn prevention1 in 1 BLISTER PACKTABLET, FILM COATED113
55910-194-51dg health heartburn prevention1 in 1 BLISTER PACKTABLET, FILM COATED113
55910-194-51dg health heartburn prevention8 in 1 CARTONTABLET, FILM COATED813
55910-194-71dg health heartburn prevention50 in 1 BOTTLETABLET, FILM COATED5013
55910-194-71dg health heartburn prevention1 in 1 CARTONTABLET, FILM COATED113
55910-194-78dg health heartburn prevention1 in 1 CARTONTABLET, FILM COATED113
55910-194-78dg health heartburn prevention100 in 1 BOTTLETABLET, FILM COATED10013
55910-194-82dg health heartburn prevention1 in 1 CARTONTABLET, FILM COATED113
55910-194-82dg health heartburn prevention200 in 1 BOTTLETABLET, FILM COATED20013

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FAMOTIDINEACTIVE INGREDIENT5QZO15J2Z8DG HEALTH HEARTBURN PREVENTION (FAMOTIDINE) TABLET [DOLGENCORP INC]2
FAMOTIDINEACTIVE MOIETY5QZO15J2Z8DG HEALTH HEARTBURN PREVENTION (FAMOTIDINE) TABLET [DOLGENCORP INC]2
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZDG HEALTH HEARTBURN PREVENTION (FAMOTIDINE) TABLET [DOLGENCORP INC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDG HEALTH HEARTBURN PREVENTION (FAMOTIDINE) TABLET [DOLGENCORP INC]2
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DG HEALTH HEARTBURN PREVENTION (FAMOTIDINE) TABLET [DOLGENCORP INC]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48DG HEALTH HEARTBURN PREVENTION (FAMOTIDINE) TABLET [DOLGENCORP INC]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDG HEALTH HEARTBURN PREVENTION (FAMOTIDINE) TABLET [DOLGENCORP INC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DG HEALTH HEARTBURN PREVENTION (FAMOTIDINE) TABLET [DOLGENCORP INC]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADG HEALTH HEARTBURN PREVENTION (FAMOTIDINE) TABLET [DOLGENCORP INC]2
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990DG HEALTH HEARTBURN PREVENTION (FAMOTIDINE) TABLET [DOLGENCORP INC]2
TALCINACTIVE INGREDIENT7SEV7J4R1UDG HEALTH HEARTBURN PREVENTION (FAMOTIDINE) TABLET [DOLGENCORP INC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDG HEALTH HEARTBURN PREVENTION (FAMOTIDINE) TABLET [DOLGENCORP INC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-194DG HEALTH HEARTBURN PREVENTION (FAMOTIDINE) TABLET, FILM COATED [DOLGENCORP INC]13Current NDC, Legacy NDC, 12 package rows20241113_679cdecb-9e25-4f43-b4f4-7f5f3fbf2296.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310273famotidine 20 MG Oral TabletPSN679cdecb-9e25-4f43-b4f4-7f5f3fbf229613
310273famotidine 20 MG Oral TabletSCD679cdecb-9e25-4f43-b4f4-7f5f3fbf229613

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55910-194-025591001940225 BLISTER PACK in 1 CARTON (55910-194-02) / 1 TABLET, FILM COATED in 1 BLISTER PACK25 blister pack2010-02-140000-00-00NoNoCurrent
55910-194-395591001943930 in 1 CARTONHistorical
55910-194-51559100194518 BLISTER PACK in 1 CARTON (55910-194-51) / 1 TABLET, FILM COATED in 1 BLISTER PACK8 blister pack2020-03-170000-00-00NoNoCurrent
55910-194-71559100194711 BOTTLE in 1 CARTON (55910-194-71) / 50 TABLET, FILM COATED in 1 BOTTLE1 bottle2020-02-030000-00-00NoNoCurrent
55910-194-78559100194781 BOTTLE in 1 CARTON (55910-194-78) / 100 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-07-150000-00-00NoNoCurrent
55910-194-82559100194821 BOTTLE in 1 CARTON (55910-194-82) / 200 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-05-280000-00-00NoNoCurrent