FDA.reportPublic FDA data

Famotidine

Product NDC
52959-116
11-digit product format
529590116
Labeler code
52959
Product ID
52959-116_01a96480-6037-4c00-8f36-f3413fd796df
Type
HUMAN OTC DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET
Route
ORAL
Labeler
H.J. Harkins Company, Inc.
Application
ANDA075805
Marketing category
ANDA
Marketing start
2001-04-16
Marketing end
0000-00-00
Substance
FAMOTIDINE
Active strength
40 mg/1
NDC exclude flag
E
Listing certified through
2017-12-31
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
52959-116-302019-11-13C16284748780-197449f38-bbd0-f6ea-e053-dbdaa90aa703Famotidine Tablets USP
52959-116-602019-11-13C16284748780-197449f38-bbd0-f6ea-e053-dbdaa90aa703Famotidine Tablets USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-116-30Famotidine30 in 1 BOTTLE, PLASTICTABLET302
52959-116-60Famotidine60 in 1 BOTTLE, PLASTICTABLET602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-116-30EA - Each52959-11602387845-444b-4c6f-b761-e1a9e831a63012012-07-24
52959-116-60EA - Each52959-116f56d1e6e-c9d6-4d63-808c-28da6aaca0ee12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FamotidineACTIVE INGREDIENT5QZO15J2Z8FAMOTIDINE TABLET [H.J. HARKINS COMPANY, INC.]2
FamotidineACTIVE MOIETY5QZO15J2Z8FAMOTIDINE TABLET [H.J. HARKINS COMPANY, INC.]2
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UFAMOTIDINE TABLET [H.J. HARKINS COMPANY, INC.]2
magnesium stearateINACTIVE INGREDIENT70097M6I30FAMOTIDINE TABLET [H.J. HARKINS COMPANY, INC.]2
polydextroseINACTIVE INGREDIENTVH2XOU12IEFAMOTIDINE TABLET [H.J. HARKINS COMPANY, INC.]2
sodium starch glycolate type A potatoINACTIVE INGREDIENT5856J3G2A2FAMOTIDINE TABLET [H.J. HARKINS COMPANY, INC.]2
starch, cornINACTIVE INGREDIENTO8232NY3SJFAMOTIDINE TABLET [H.J. HARKINS COMPANY, INC.]2
talcINACTIVE INGREDIENT7SEV7J4R1UFAMOTIDINE TABLET [H.J. HARKINS COMPANY, INC.]2
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPFAMOTIDINE TABLET [H.J. HARKINS COMPANY, INC.]2
triacetinINACTIVE INGREDIENTXHX3C3X673FAMOTIDINE TABLET [H.J. HARKINS COMPANY, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-116FAMOTIDINE TABLET [H.J. HARKINS COMPANY, INC.]2Legacy NDC, 2 package rows20111201_cc3d40b6-d058-496c-accb-4bf12d2f3156.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
284245famotidine 40 MG Oral TabletPSNcc3d40b6-d058-496c-accb-4bf12d2f31562
284245famotidine 40 MG Oral TabletSCDcc3d40b6-d058-496c-accb-4bf12d2f31562

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-116-305295901163030 in 1 BOTTLE, PLASTICHistorical
52959-116-605295901166060 in 1 BOTTLE, PLASTICHistorical