FDA.reportPublic FDA data

Good Sense Acid Reducer

Product NDC
0113-0194
11-digit product format
001130194
Labeler code
0113
Product ID
0113-0194_80ef8ca0-0d3d-400f-be18-9b125b11ee76
Type
HUMAN OTC DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
L. Perrigo Company
Application
ANDA077351
Marketing category
ANDA
Marketing start
2007-03-16
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
Good Sense Acid Reducer
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
0113-0194-00Good Sense Acid Reducer200 in 1 BOTTLETABLET, FILM COATED2009
0113-0194-00Good Sense Acid Reducer2 in 1 CARTONTABLET, FILM COATED29
0113-0194-02Good Sense Acid Reducer1 in 1 BLISTER PACKTABLET, FILM COATED19
0113-0194-02Good Sense Acid Reducer25 in 1 CARTONTABLET, FILM COATED259
0113-0194-63Good Sense Acid Reducer1 in 1 CARTONTABLET, FILM COATED19
0113-0194-63Good Sense Acid Reducer25 in 1 BOTTLETABLET, FILM COATED259
0113-0194-71Good Sense Acid Reducer50 in 1 BOTTLETABLET, FILM COATED509
0113-0194-71Good Sense Acid Reducer1 in 1 CARTONTABLET, FILM COATED19
0113-0194-82Good Sense Acid Reducer200 in 1 BOTTLETABLET, FILM COATED2009
0113-0194-82Good Sense Acid Reducer1 in 1 CARTONTABLET, FILM COATED19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0113-0194-02EA - Each0113-01942b4abdac-a078-4321-871e-9277511fafdc12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FAMOTIDINEACTIVE INGREDIENT5QZO15J2Z8GOOD SENSE ACID REDUCER (FAMOTIDINE) TABLET [L PERRIGO COMPANY]1
FAMOTIDINEACTIVE MOIETY5QZO15J2Z8GOOD SENSE ACID REDUCER (FAMOTIDINE) TABLET [L PERRIGO COMPANY]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZGOOD SENSE ACID REDUCER (FAMOTIDINE) TABLET [L PERRIGO COMPANY]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGOOD SENSE ACID REDUCER (FAMOTIDINE) TABLET [L PERRIGO COMPANY]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48GOOD SENSE ACID REDUCER (FAMOTIDINE) TABLET [L PERRIGO COMPANY]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XGOOD SENSE ACID REDUCER (FAMOTIDINE) TABLET [L PERRIGO COMPANY]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GOOD SENSE ACID REDUCER (FAMOTIDINE) TABLET [L PERRIGO COMPANY]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AGOOD SENSE ACID REDUCER (FAMOTIDINE) TABLET [L PERRIGO COMPANY]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990GOOD SENSE ACID REDUCER (FAMOTIDINE) TABLET [L PERRIGO COMPANY]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4GOOD SENSE ACID REDUCER (FAMOTIDINE) TABLET [L PERRIGO COMPANY]1
TALCINACTIVE INGREDIENT7SEV7J4R1UGOOD SENSE ACID REDUCER (FAMOTIDINE) TABLET [L PERRIGO COMPANY]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGOOD SENSE ACID REDUCER (FAMOTIDINE) TABLET [L PERRIGO COMPANY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0113-0194GOOD SENSE ACID REDUCER (FAMOTIDINE) TABLET, FILM COATED [L. PERRIGO COMPANY]8Current NDC, Legacy NDC, 10 package rows20250209_39cb0f15-d177-46eb-a549-7acb885fbf07.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310273famotidine 20 MG Oral TabletPSN39cb0f15-d177-46eb-a549-7acb885fbf079
310273famotidine 20 MG Oral TabletSCD39cb0f15-d177-46eb-a549-7acb885fbf079
310273famotidine 20 MG Oral TabletPSNde42b6c4-c44b-4ec1-b505-fc5266452d573
310273famotidine 20 MG Oral TabletSCDde42b6c4-c44b-4ec1-b505-fc5266452d573

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0113-0194-00001130194002 BOTTLE in 1 CARTON (0113-0194-00) / 200 TABLET, FILM COATED in 1 BOTTLE2 bottle2024-10-31NoNoCurrent
0113-0194-020011301940225 BLISTER PACK in 1 CARTON (0113-0194-02) / 1 TABLET, FILM COATED in 1 BLISTER PACK25 blister pack2007-03-160000-00-00NoNoCurrent
0113-0194-63001130194631 BOTTLE in 1 CARTON (0113-0194-63) > 25 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-04-220000-00-00NoNoCurrent
0113-0194-71001130194711 BOTTLE in 1 CARTON (0113-0194-71) / 50 TABLET, FILM COATED in 1 BOTTLE1 bottle2013-09-190000-00-00NoNoCurrent
0113-0194-82001130194821 BOTTLE in 1 CARTON (0113-0194-82) / 200 TABLET, FILM COATED in 1 BOTTLE1 bottle2024-05-30NoNoCurrent