FDA.reportPublic FDA data

Famotidine

Product NDC
50436-7371
11-digit product format
504367371
Labeler code
50436
Product ID
50436-7371_1cfb6c8d-e054-4596-989e-dd2886d94877
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA075805
Marketing category
ANDA
Marketing start
2001-04-16
Marketing end
0000-00-00
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
2020-12-31
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
50436-7371-12021-01-29C16284748780-1ba0f9c33-3645-a910-e053-dadaa90a0b85Famotidine Tablets USP
50436-7371-22021-01-29C16284748780-1ba0f9c33-3645-a910-e053-dadaa90a0b85Famotidine Tablets USP
50436-7371-32021-01-29C16284748780-1ba0f9c33-3645-a910-e053-dadaa90a0b85Famotidine Tablets USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-7371-1Famotidine60 in 1 BOTTLETABLET604
50436-7371-2Famotidine30 in 1 BOTTLETABLET304
50436-7371-3Famotidine90 in 1 BOTTLETABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50436-7371-2EA - Each50436-737102164c75-1f8c-4b02-bd26-895797121fe012016-06-14
50436-7371-3EA - Each50436-7371a2512b41-096c-4dcd-b6eb-ccd1f0b1d18d12016-05-16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FamotidineACTIVE INGREDIENT5QZO15J2Z8FAMOTIDINE TABLET [UNIT DOSE SERVICES]2
FamotidineACTIVE MOIETY5QZO15J2Z8FAMOTIDINE TABLET [UNIT DOSE SERVICES]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFAMOTIDINE TABLET [UNIT DOSE SERVICES]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FAMOTIDINE TABLET [UNIT DOSE SERVICES]2
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEFAMOTIDINE TABLET [UNIT DOSE SERVICES]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2FAMOTIDINE TABLET [UNIT DOSE SERVICES]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJFAMOTIDINE TABLET [UNIT DOSE SERVICES]2
TALCINACTIVE INGREDIENT7SEV7J4R1UFAMOTIDINE TABLET [UNIT DOSE SERVICES]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFAMOTIDINE TABLET [UNIT DOSE SERVICES]2
TRIACETININACTIVE INGREDIENTXHX3C3X673FAMOTIDINE TABLET [UNIT DOSE SERVICES]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-7371FAMOTIDINE TABLET [UNIT DOSE SERVICES]4Legacy NDC, 3 package rows20160429_f55c8069-bfc1-4e37-b359-d3d1b10804ae.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310273famotidine 20 MG Oral TabletPSNf55c8069-bfc1-4e37-b359-d3d1b10804ae4
310273famotidine 20 MG Oral TabletSCDf55c8069-bfc1-4e37-b359-d3d1b10804ae4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-7371-15043673710160 in 1 BOTTLEHistorical
50436-7371-25043673710230 in 1 BOTTLEHistorical
50436-7371-35043673710390 in 1 BOTTLEHistorical