FDA.reportPublic FDA data

heartburn prevention

Product NDC
30142-194
11-digit product format
301420194
Labeler code
30142
Product ID
30142-194_c1cf5e39-9332-4823-9c3f-f6976bda5b1c
Type
HUMAN OTC DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Kroger Company
Application
ANDA077351
Marketing category
ANDA
Marketing start
2015-02-05
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
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
30142-194-01heartburn prevention1 in 1 CARTONTABLET, FILM COATED110
30142-194-01heartburn prevention85 in 1 BOTTLETABLET, FILM COATED8510
30142-194-02heartburn prevention1 in 1 BLISTER PACKTABLET, FILM COATED110
30142-194-02heartburn prevention25 in 1 CARTONTABLET, FILM COATED2510
30142-194-71heartburn prevention50 in 1 BOTTLETABLET, FILM COATED5010
30142-194-71heartburn prevention1 in 1 CARTONTABLET, FILM COATED110
30142-194-72heartburn prevention1 in 1 CARTONTABLET, FILM COATED110
30142-194-72heartburn prevention60 in 1 BOTTLETABLET, FILM COATED6010
30142-194-98heartburn prevention75 in 1 BOTTLETABLET, FILM COATED7510
30142-194-98heartburn prevention1 in 1 CARTONTABLET, FILM COATED110

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FAMOTIDINEACTIVE INGREDIENT5QZO15J2Z8HEARTBURN PREVENTION (FAMOTIDINE) TABLET [KROGER COMPANY]1
FAMOTIDINEACTIVE MOIETY5QZO15J2Z8HEARTBURN PREVENTION (FAMOTIDINE) TABLET [KROGER COMPANY]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZHEARTBURN PREVENTION (FAMOTIDINE) TABLET [KROGER COMPANY]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHEARTBURN PREVENTION (FAMOTIDINE) TABLET [KROGER COMPANY]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48HEARTBURN PREVENTION (FAMOTIDINE) TABLET [KROGER COMPANY]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XHEARTBURN PREVENTION (FAMOTIDINE) TABLET [KROGER COMPANY]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HEARTBURN PREVENTION (FAMOTIDINE) TABLET [KROGER COMPANY]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AHEARTBURN PREVENTION (FAMOTIDINE) TABLET [KROGER COMPANY]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990HEARTBURN PREVENTION (FAMOTIDINE) TABLET [KROGER COMPANY]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HEARTBURN PREVENTION (FAMOTIDINE) TABLET [KROGER COMPANY]1
TALCINACTIVE INGREDIENT7SEV7J4R1UHEARTBURN PREVENTION (FAMOTIDINE) TABLET [KROGER COMPANY]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHEARTBURN PREVENTION (FAMOTIDINE) TABLET [KROGER COMPANY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
30142-194HEARTBURN PREVENTION (FAMOTIDINE) TABLET, FILM COATED [KROGER COMPANY]9Current NDC, Legacy NDC, 10 package rows20250214_c97851ef-7b49-4f6c-b165-147555db101a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310273famotidine 20 MG Oral TabletPSNc97851ef-7b49-4f6c-b165-147555db101a10
310273famotidine 20 MG Oral TabletSCDc97851ef-7b49-4f6c-b165-147555db101a10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
30142-194-01301420194011 BOTTLE in 1 CARTON (30142-194-01) / 85 TABLET, FILM COATED in 1 BOTTLE1 bottle2024-05-21NoNoCurrent
30142-194-02301420194021 in 1 BLISTER PACKHistorical
30142-194-71301420194711 BOTTLE in 1 CARTON (30142-194-71) / 50 TABLET, FILM COATED in 1 BOTTLE1 bottle2015-02-050000-00-00NoNoCurrent
30142-194-72301420194721 BOTTLE in 1 CARTON (30142-194-72) > 60 TABLET, FILM COATED in 1 BOTTLE1 bottle2016-12-230000-00-00NoNoCurrent
30142-194-98301420194981 BOTTLE in 1 CARTON (30142-194-98) / 75 TABLET, FILM COATED in 1 BOTTLE1 bottle2025-04-14NoNoCurrent