FDA.reportPublic FDA data

Heartburn Relief

Product NDC
52904-448
11-digit product format
529040448
Labeler code
52904
Product ID
52904-448_a3f26a2a-f404-4d48-bbae-0ee263ff409b
Type
HUMAN OTC DRUG
Nonproprietary name
FAMOTIDINE
Dosage form
TABLET
Route
ORAL
Labeler
Select Corporation
Application
ANDA077146
Marketing category
ANDA
Marketing start
2014-03-14
Marketing end
0000-00-00
Substance
FAMOTIDINE
Active strength
10 mg/1
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52904-448-012020-01-31C16284748780-19d75b9d0-7b82-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52904-448-01Heartburn Relief1 in 1 PACKETTABLET12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FAMOTIDINEACTIVE INGREDIENT5QZO15J2Z8HEARTBURN RELIEF (FAMOTIDINE) TABLET [SELECT CORPORATION]2
FAMOTIDINEACTIVE MOIETY5QZO15J2Z8HEARTBURN RELIEF (FAMOTIDINE) TABLET [SELECT CORPORATION]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHEARTBURN RELIEF (FAMOTIDINE) TABLET [SELECT CORPORATION]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675HEARTBURN RELIEF (FAMOTIDINE) TABLET [SELECT CORPORATION]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HEARTBURN RELIEF (FAMOTIDINE) TABLET [SELECT CORPORATION]2
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQHEARTBURN RELIEF (FAMOTIDINE) TABLET [SELECT CORPORATION]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHEARTBURN RELIEF (FAMOTIDINE) TABLET [SELECT CORPORATION]2
TALCINACTIVE INGREDIENT7SEV7J4R1UHEARTBURN RELIEF (FAMOTIDINE) TABLET [SELECT CORPORATION]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHEARTBURN RELIEF (FAMOTIDINE) TABLET [SELECT CORPORATION]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52904-448HEARTBURN RELIEF (FAMOTIDINE) TABLET [SELECT CORPORATION]2Legacy NDC, 1 package rows20140414_ce584e98-5d52-4412-b18c-e623b4ae24d1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199047famotidine 10 MG Oral TabletPSNce584e98-5d52-4412-b18c-e623b4ae24d12
199047famotidine 10 MG Oral TabletSCDce584e98-5d52-4412-b18c-e623b4ae24d12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52904-448-01529040448011 in 1 PACKETHistorical