Signature Care Acid Controller

Product NDC
21130-777
11-digit product format
211300777
Labeler code
21130
Product ID
21130-777_9dfc87b3-cb54-427e-a28f-850117e8103b
Type
HUMAN OTC DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Safeway
Application
ANDA077351
Marketing category
ANDA
Marketing start
2015-09-04
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
Signature Care Acid Controller
Brand name suffix
maximum strength
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
21130-777-02Signature Care Acid Controllermaximum strength1 in 1 BLISTER PACKTABLET, FILM COATED15
21130-777-02Signature Care Acid Controllermaximum strength25 in 1 CARTONTABLET, FILM COATED255
21130-777-71Signature Care Acid Controllermaximum strength50 in 1 BOTTLETABLET, FILM COATED505
21130-777-71Signature Care Acid Controllermaximum strength1 in 1 CARTONTABLET, FILM COATED15
21130-777-82Signature Care Acid Controllermaximum strength1 in 1 CARTONTABLET, FILM COATED15
21130-777-82Signature Care Acid Controllermaximum strength200 in 1 BOTTLETABLET, FILM COATED2005

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FAMOTIDINEACTIVE INGREDIENT5QZO15J2Z8SIGNATURE CARE ACID CONTROLLER MAXIMUM STRENGTH (FAMOTIDINE) TABLET [SAFEWAY]1
FAMOTIDINEACTIVE MOIETY5QZO15J2Z8SIGNATURE CARE ACID CONTROLLER MAXIMUM STRENGTH (FAMOTIDINE) TABLET [SAFEWAY]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZSIGNATURE CARE ACID CONTROLLER MAXIMUM STRENGTH (FAMOTIDINE) TABLET [SAFEWAY]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USIGNATURE CARE ACID CONTROLLER MAXIMUM STRENGTH (FAMOTIDINE) TABLET [SAFEWAY]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48SIGNATURE CARE ACID CONTROLLER MAXIMUM STRENGTH (FAMOTIDINE) TABLET [SAFEWAY]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XSIGNATURE CARE ACID CONTROLLER MAXIMUM STRENGTH (FAMOTIDINE) TABLET [SAFEWAY]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SIGNATURE CARE ACID CONTROLLER MAXIMUM STRENGTH (FAMOTIDINE) TABLET [SAFEWAY]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ASIGNATURE CARE ACID CONTROLLER MAXIMUM STRENGTH (FAMOTIDINE) TABLET [SAFEWAY]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990SIGNATURE CARE ACID CONTROLLER MAXIMUM STRENGTH (FAMOTIDINE) TABLET [SAFEWAY]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4SIGNATURE CARE ACID CONTROLLER MAXIMUM STRENGTH (FAMOTIDINE) TABLET [SAFEWAY]1
TALCINACTIVE INGREDIENT7SEV7J4R1USIGNATURE CARE ACID CONTROLLER MAXIMUM STRENGTH (FAMOTIDINE) TABLET [SAFEWAY]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSIGNATURE CARE ACID CONTROLLER MAXIMUM STRENGTH (FAMOTIDINE) TABLET [SAFEWAY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-777SIGNATURE CARE ACID CONTROLLER MAXIMUM STRENGTH (FAMOTIDINE) TABLET, FILM COATED [SAFEWAY]5Current NDC, Legacy NDC, 6 package rows20210722_ca5edcf8-1ed2-403a-a01b-0deb692bee0c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310273famotidine 20 MG Oral TabletPSNca5edcf8-1ed2-403a-a01b-0deb692bee0c5
310273famotidine 20 MG Oral TabletSCDca5edcf8-1ed2-403a-a01b-0deb692bee0c5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
21130-777-022113007770225 BLISTER PACK in 1 CARTON (21130-777-02) / 1 TABLET, FILM COATED in 1 BLISTER PACK25 blister pack2015-09-060000-00-00NoNoCurrent
21130-777-71211300777711 BOTTLE in 1 CARTON (21130-777-71) / 50 TABLET, FILM COATED in 1 BOTTLE1 bottle2015-09-040000-00-00NoNoCurrent
21130-777-82211300777821 BOTTLE in 1 CARTON (21130-777-82) / 200 TABLET, FILM COATED in 1 BOTTLE1 bottle2015-09-040000-00-00NoNoCurrent