FDA.reportPublic FDA data

Famotidine

Product NDC
55648-936
11-digit product format
556480936
Labeler code
55648
Product ID
55648-936_b0208b67-58f7-4e87-9dc2-48cb6d9d9790
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Wockhardt Limited
Application
ANDA075786
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
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
4fdc761c-585e-054b-8ebe-86130a26e4c1Product name220221205
fc2e1e31-353a-2c24-a4b4-fcf93bf7e38eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55648-936-012019-11-13C16284748780-197449f38-cf08-f6ea-e053-dbdaa90aa703Famotidine Tablets, USP
55648-936-022019-11-13C16284748780-197449f38-cf08-f6ea-e053-dbdaa90aa703Famotidine Tablets, USP
55648-936-032019-11-13C16284748780-197449f38-cf08-f6ea-e053-dbdaa90aa703Famotidine Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55648-936-01Famotidine30 in 1 BOTTLETABLET, FILM COATED302
55648-936-02Famotidine100 in 1 BOTTLETABLET, FILM COATED1002
55648-936-03Famotidine1000 in 1 BOTTLETABLET, FILM COATED10002

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FAMOTIDINEACTIVE INGREDIENT5QZO15J2Z8FAMOTIDINE TABLET, FILM COATED [WOCKHARDT LIMITED]2
FAMOTIDINEACTIVE MOIETY5QZO15J2Z8FAMOTIDINE TABLET, FILM COATED [WOCKHARDT LIMITED]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFAMOTIDINE TABLET, FILM COATED [WOCKHARDT LIMITED]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675FAMOTIDINE TABLET, FILM COATED [WOCKHARDT LIMITED]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTFAMOTIDINE TABLET, FILM COATED [WOCKHARDT LIMITED]2
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14FAMOTIDINE TABLET, FILM COATED [WOCKHARDT LIMITED]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOFAMOTIDINE TABLET, FILM COATED [WOCKHARDT LIMITED]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FAMOTIDINE TABLET, FILM COATED [WOCKHARDT LIMITED]2
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQFAMOTIDINE TABLET, FILM COATED [WOCKHARDT LIMITED]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJFAMOTIDINE TABLET, FILM COATED [WOCKHARDT LIMITED]2
TALCINACTIVE INGREDIENT7SEV7J4R1UFAMOTIDINE TABLET, FILM COATED [WOCKHARDT LIMITED]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFAMOTIDINE TABLET, FILM COATED [WOCKHARDT LIMITED]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55648-936FAMOTIDINE TABLET, FILM COATED [WOCKHARDT LIMITED]2Legacy NDC, 3 package rows20120907_199c7249-4ffa-4889-a53a-ffd58653914f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310273famotidine 20 MG Oral TabletPSN199c7249-4ffa-4889-a53a-ffd58653914f2
284245famotidine 40 MG Oral TabletPSN199c7249-4ffa-4889-a53a-ffd58653914f2
310273famotidine 20 MG Oral TabletSCD199c7249-4ffa-4889-a53a-ffd58653914f2
284245famotidine 40 MG Oral TabletSCD199c7249-4ffa-4889-a53a-ffd58653914f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
55648-936-015564809360130 in 1 BOTTLEHistorical
55648-936-0255648093602100 in 1 BOTTLEHistorical
55648-936-03556480936031000 in 1 BOTTLEHistorical