FDA.reportPublic FDA data

Famotidine

Product NDC
68151-0185
11-digit product format
681510185
Labeler code
68151
Product ID
68151-0185_faab6646-d9d0-4835-9b83-d55e34a2520d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Carilion Materials Management
Application
ANDA075786
Marketing category
ANDA
Marketing start
2001-04-16
Marketing end
0000-00-00
Substance
FAMOTIDINE
Active strength
40 mg/1
Pharmacologic classes
Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC]
NDC exclude flag
E
Listing certified through
2018-12-31
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
68151-0185-02020-01-31C16284748780-19d75b9d0-cade-f424-e053-dadaa90a57ceFamotidine Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68151-0185-0Famotidine1 in 1 PACKAGETABLET, FILM COATED12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FAMOTIDINEACTIVE INGREDIENT5QZO15J2Z8FAMOTIDINE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
FAMOTIDINEACTIVE MOIETY5QZO15J2Z8FAMOTIDINE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFAMOTIDINE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14FAMOTIDINE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOFAMOTIDINE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FAMOTIDINE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQFAMOTIDINE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJFAMOTIDINE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
TALCINACTIVE INGREDIENT7SEV7J4R1UFAMOTIDINE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFAMOTIDINE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68151-0185FAMOTIDINE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2Legacy NDC, 1 package rows20140707_ac59de71-1637-42ef-a028-339e43ea3edd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
284245famotidine 40 MG Oral TabletPSNac59de71-1637-42ef-a028-339e43ea3edd2
284245famotidine 40 MG Oral TabletSCDac59de71-1637-42ef-a028-339e43ea3edd2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68151-0185-0681510185001 in 1 PACKAGEHistorical