FDA.reportPublic FDA data

Original strength heartburn prevention

Product NDC
41226-719
11-digit product format
412260719
Labeler code
41226
Product ID
41226-719_1cb86ee4-41c1-1196-e063-6394a90a9199
Type
HUMAN OTC DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET
Route
ORAL
Labeler
KROGER COMPANY
Application
ANDA217543
Marketing category
ANDA
Marketing start
2023-05-05
Substance
FAMOTIDINE
Active strength
10 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
Original strength heartburn prevention
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FAMOTIDINE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5QZO15J2Z8
Rxcui199047

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
41226-719-06Original strength heartburn prevention10 in 1 BLISTER PACKTABLET103
41226-719-06Original strength heartburn prevention3 in 1 CARTONTABLET33
41226-719-09Original strength heartburn prevention1 in 1 CARTONTABLET13
41226-719-09Original strength heartburn prevention90 in 1 BOTTLETABLET903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41226-719ORIGINAL STRENGTH HEARTBURN PREVENTION (FAMOTIDINE) TABLET [KROGER COMPANY]3Current NDC, 4 package rows20240709_ea1c2838-acbd-18e0-e053-2a95a90a3522.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199047famotidine 10 MG Oral TabletPSNea1c2838-acbd-18e0-e053-2a95a90a35223
199047famotidine 10 MG Oral TabletSCDea1c2838-acbd-18e0-e053-2a95a90a35223

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
41226-719-06412260719063 BLISTER PACK in 1 CARTON (41226-719-06) / 10 TABLET in 1 BLISTER PACK3 blister pack2023-05-05NoNoCurrent
41226-719-09412260719091 BOTTLE in 1 CARTON (41226-719-09) / 90 TABLET in 1 BOTTLE1 bottle2024-04-15NoNoCurrent