FDA.reportPublic FDA data

Equate Famotidine

Product NDC
49035-650
11-digit product format
490350650
Labeler code
49035
Product ID
49035-650_f58d95e7-ece2-4080-adf8-8cb66cd19d71
Type
HUMAN OTC DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Wal-Mart Stores Inc
Application
ANDA077351
Marketing category
ANDA
Marketing start
2007-05-02
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
Equate Famotidine
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
49035-650-63Equate Famotidine1 in 1 CARTONTABLET, FILM COATED19
49035-650-63Equate Famotidine25 in 1 BOTTLETABLET, FILM COATED259
49035-650-71Equate Famotidine1 in 1 CARTONTABLET, FILM COATED19
49035-650-71Equate Famotidine50 in 1 BOTTLETABLET, FILM COATED509
49035-650-72Equate Famotidine1 in 1 CARTONTABLET, FILM COATED19
49035-650-72Equate Famotidine60 in 1 BOTTLETABLET, FILM COATED609
49035-650-78Equate Famotidine100 in 1 BOTTLETABLET, FILM COATED1009
49035-650-78Equate Famotidine1 in 1 CARTONTABLET, FILM COATED19
49035-650-82Equate Famotidine100 in 1 BOTTLETABLET, FILM COATED1009
49035-650-82Equate Famotidine2 in 1 CARTONTABLET, FILM COATED29

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49035-650-71EA - Each49035-650860a7d7f-448f-44ec-9a29-c8d0695f659212023-03-13
49035-650-78EA - Each49035-650f6e73ef6-4002-4cd7-9eef-755edb38d49612023-03-13
49035-650-82EA - Each49035-6502ccefc12-ba6a-487c-af32-22124181bc5c12020-09-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FAMOTIDINEACTIVE INGREDIENT5QZO15J2Z8EQUATE FAMOTIDINE (FAMOTIDINE) TABLET [WAL-MART STORES INC]2
FAMOTIDINEACTIVE MOIETY5QZO15J2Z8EQUATE FAMOTIDINE (FAMOTIDINE) TABLET [WAL-MART STORES INC]2
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZEQUATE FAMOTIDINE (FAMOTIDINE) TABLET [WAL-MART STORES INC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UEQUATE FAMOTIDINE (FAMOTIDINE) TABLET [WAL-MART STORES INC]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48EQUATE FAMOTIDINE (FAMOTIDINE) TABLET [WAL-MART STORES INC]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XEQUATE FAMOTIDINE (FAMOTIDINE) TABLET [WAL-MART STORES INC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30EQUATE FAMOTIDINE (FAMOTIDINE) TABLET [WAL-MART STORES INC]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AEQUATE FAMOTIDINE (FAMOTIDINE) TABLET [WAL-MART STORES INC]2
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990EQUATE FAMOTIDINE (FAMOTIDINE) TABLET [WAL-MART STORES INC]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4EQUATE FAMOTIDINE (FAMOTIDINE) TABLET [WAL-MART STORES INC]2
TALCINACTIVE INGREDIENT7SEV7J4R1UEQUATE FAMOTIDINE (FAMOTIDINE) TABLET [WAL-MART STORES INC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPEQUATE FAMOTIDINE (FAMOTIDINE) TABLET [WAL-MART STORES INC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-650EQUATE FAMOTIDINE (FAMOTIDINE) TABLET, FILM COATED [WAL-MART STORES INC]8Current NDC, Legacy NDC, 10 package rows20250212_8ac94821-aa78-4e57-bc9a-f1f2a0e47b07.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310273famotidine 20 MG Oral TabletPSN8ac94821-aa78-4e57-bc9a-f1f2a0e47b079
310273famotidine 20 MG Oral TabletSCD8ac94821-aa78-4e57-bc9a-f1f2a0e47b079

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-650-63490350650631 in 1 CARTONHistorical
49035-650-71490350650711 BOTTLE in 1 CARTON (49035-650-71) / 50 TABLET, FILM COATED in 1 BOTTLE1 bottle2007-05-020000-00-00NoNoCurrent
49035-650-72490350650721 in 1 CARTONHistorical
49035-650-78490350650781 BOTTLE in 1 CARTON (49035-650-78) / 100 TABLET, FILM COATED in 1 BOTTLE1 bottle2013-07-150000-00-00NoNoCurrent
49035-650-82490350650822 BOTTLE in 1 CARTON (49035-650-82) > 100 TABLET, FILM COATED in 1 BOTTLE2 bottle2013-04-020000-00-00NoNoCurrent