FDA.reportPublic FDA data

acid controller

Product NDC
59779-194
11-digit product format
597790194
Labeler code
59779
Product ID
59779-194_a437ab2b-07b7-44d2-8326-3de4df3c7b88
Type
HUMAN OTC DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
CVS Pharmacy
Application
ANDA077351
Marketing category
ANDA
Marketing start
2006-09-28
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
acid controller
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
4fdc761c-585e-054b-8ebe-86130a26e4c1Product name220221205
fc2e1e31-353a-2c24-a4b4-fcf93bf7e38eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59779-194-02acid controller1 in 1 BLISTER PACKTABLET, FILM COATED111
59779-194-02acid controller25 in 1 CARTONTABLET, FILM COATED2511
59779-194-51acid controller1 in 1 BLISTER PACKTABLET, FILM COATED111
59779-194-51acid controller8 in 1 CARTONTABLET, FILM COATED811
59779-194-63acid controller25 in 1 BOTTLETABLET, FILM COATED2511
59779-194-63acid controller1 in 1 CARTONTABLET, FILM COATED111
59779-194-71acid controller50 in 1 BOTTLETABLET, FILM COATED5011
59779-194-71acid controller1 in 1 CARTONTABLET, FILM COATED111
59779-194-72acid controller1 in 1 CARTONTABLET, FILM COATED111
59779-194-72acid controller60 in 1 BOTTLETABLET, FILM COATED6011
59779-194-78acid controller1 in 1 CARTONTABLET, FILM COATED111
59779-194-78acid controller100 in 1 BOTTLETABLET, FILM COATED10011
59779-194-82acid controller1 in 1 CARTONTABLET, FILM COATED111
59779-194-82acid controller200 in 1 BOTTLETABLET, FILM COATED20011
59779-194-98acid controller75 in 1 BOTTLETABLET, FILM COATED7511
59779-194-98acid controller1 in 1 CARTONTABLET, FILM COATED111

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59779-194-02EA - Each59779-19421aae781-2d20-47e1-a78f-6978424b4d3112012-07-24
59779-194-51EA - Each59779-194352bec6e-55ec-4356-a298-841c10d4870112012-07-24
59779-194-63EA - Each59779-19482d6cc29-750e-4415-bd4c-0c7f512655b112018-05-09
59779-194-71EA - Each59779-194204fface-ea69-45b0-850d-c74651eee68412012-07-24
59779-194-78EA - Each59779-194cbd74956-794e-4a4b-a164-565b3563155712018-07-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FAMOTIDINEACTIVE INGREDIENT5QZO15J2Z8ACID CONTROLLER (FAMOTIDINE) TABLET [CVS PHARMACY]2
FAMOTIDINEACTIVE MOIETY5QZO15J2Z8ACID CONTROLLER (FAMOTIDINE) TABLET [CVS PHARMACY]2
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZACID CONTROLLER (FAMOTIDINE) TABLET [CVS PHARMACY]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UACID CONTROLLER (FAMOTIDINE) TABLET [CVS PHARMACY]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ACID CONTROLLER (FAMOTIDINE) TABLET [CVS PHARMACY]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XACID CONTROLLER (FAMOTIDINE) TABLET [CVS PHARMACY]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ACID CONTROLLER (FAMOTIDINE) TABLET [CVS PHARMACY]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AACID CONTROLLER (FAMOTIDINE) TABLET [CVS PHARMACY]2
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990ACID CONTROLLER (FAMOTIDINE) TABLET [CVS PHARMACY]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ACID CONTROLLER (FAMOTIDINE) TABLET [CVS PHARMACY]2
TALCINACTIVE INGREDIENT7SEV7J4R1UACID CONTROLLER (FAMOTIDINE) TABLET [CVS PHARMACY]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPACID CONTROLLER (FAMOTIDINE) TABLET [CVS PHARMACY]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59779-194ACID CONTROLLER (FAMOTIDINE) TABLET, FILM COATED [CVS PHARMACY]10Current NDC, Legacy NDC, 16 package rows20250221_1531aa51-02e9-45ed-99aa-53b21732dd2e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310273famotidine 20 MG Oral TabletPSN1531aa51-02e9-45ed-99aa-53b21732dd2e11
310273famotidine 20 MG Oral TabletSCD1531aa51-02e9-45ed-99aa-53b21732dd2e11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59779-194-02597790194021 in 1 BLISTER PACKHistorical
59779-194-51597790194511 in 1 BLISTER PACKHistorical
59779-194-63597790194631 BOTTLE in 1 CARTON (59779-194-63) / 25 TABLET, FILM COATED in 1 BOTTLE1 bottle2015-09-140000-00-00NoNoCurrent
59779-194-71597790194711 BOTTLE in 1 CARTON (59779-194-71) / 50 TABLET, FILM COATED in 1 BOTTLE1 bottle2006-09-280000-00-00NoNoCurrent
59779-194-72597790194721 BOTTLE in 1 CARTON (59779-194-72) > 60 TABLET, FILM COATED in 1 BOTTLE1 bottle2009-03-110000-00-00NoNoCurrent
59779-194-78597790194781 BOTTLE in 1 CARTON (59779-194-78) / 100 TABLET, FILM COATED in 1 BOTTLE1 bottle2007-05-230000-00-00NoNoCurrent
59779-194-82597790194821 BOTTLE in 1 CARTON (59779-194-82) > 200 TABLET, FILM COATED in 1 BOTTLE1 bottle2016-06-020000-00-00NoNoCurrent
59779-194-98597790194981 BOTTLE in 1 CARTON (59779-194-98) / 75 TABLET, FILM COATED in 1 BOTTLE1 bottle2025-04-01NoNoHistorical