Premier Value Famotidine

Product NDC
68016-010
11-digit product format
680160010
Labeler code
68016
Product ID
68016-010_7ab337e1-90e1-4233-b854-19aee40ccfbe
Type
HUMAN OTC DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Premier Value
Application
ANDA090283
Marketing category
ANDA
Marketing start
2010-06-25
Marketing end
0000-00-00
Substance
FAMOTIDINE
Active strength
10 mg/1
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
68016-010-812025-01-30C16284748780-12cef2736-59c0-d83d-e063-dadaa90ab31fPremier Value ® Famotidine
68016-010-822025-01-30C16284748780-12cef2736-59c0-d83d-e063-dadaa90ab31fPremier Value ® Famotidine

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68016-010-81Premier Value Famotidine30 in 1 BLISTER PACKTABLET, FILM COATED304
68016-010-82Premier Value Famotidine60 in 1 BOTTLETABLET, FILM COATED604

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68016-010-81EA - Each68016-010fb9f6589-7c04-42e0-92ff-5bdab43844ac12022-06-06
68016-010-82EA - Each68016-0109fe6c8b1-e77b-4fe3-a1a9-658699c603f512022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FAMOTIDINEACTIVE INGREDIENT5QZO15J2Z8PREMIER VALUE FAMOTIDINE (FAMOTIDINE) TABLET, FILM COATED [PREMIER VALUE]1
FAMOTIDINEACTIVE MOIETY5QZO15J2Z8PREMIER VALUE FAMOTIDINE (FAMOTIDINE) TABLET, FILM COATED [PREMIER VALUE]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPREMIER VALUE FAMOTIDINE (FAMOTIDINE) TABLET, FILM COATED [PREMIER VALUE]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PREMIER VALUE FAMOTIDINE (FAMOTIDINE) TABLET, FILM COATED [PREMIER VALUE]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675PREMIER VALUE FAMOTIDINE (FAMOTIDINE) TABLET, FILM COATED [PREMIER VALUE]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PPREMIER VALUE FAMOTIDINE (FAMOTIDINE) TABLET, FILM COATED [PREMIER VALUE]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPREMIER VALUE FAMOTIDINE (FAMOTIDINE) TABLET, FILM COATED [PREMIER VALUE]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PREMIER VALUE FAMOTIDINE (FAMOTIDINE) TABLET, FILM COATED [PREMIER VALUE]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQPREMIER VALUE FAMOTIDINE (FAMOTIDINE) TABLET, FILM COATED [PREMIER VALUE]1
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJPREMIER VALUE FAMOTIDINE (FAMOTIDINE) TABLET, FILM COATED [PREMIER VALUE]1
TALCINACTIVE INGREDIENT7SEV7J4R1UPREMIER VALUE FAMOTIDINE (FAMOTIDINE) TABLET, FILM COATED [PREMIER VALUE]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPREMIER VALUE FAMOTIDINE (FAMOTIDINE) TABLET, FILM COATED [PREMIER VALUE]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-010PREMIER VALUE FAMOTIDINE (FAMOTIDINE) TABLET, FILM COATED [PREMIER VALUE]4Legacy NDC, 2 package rows20191231_42d1e2f2-9b9b-4a6d-9fc1-047e167153b5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199047famotidine 10 MG Oral TabletPSN42d1e2f2-9b9b-4a6d-9fc1-047e167153b54
310273famotidine 20 MG Oral TabletPSN42d1e2f2-9b9b-4a6d-9fc1-047e167153b54
199047famotidine 10 MG Oral TabletSCD42d1e2f2-9b9b-4a6d-9fc1-047e167153b54
310273famotidine 20 MG Oral TabletSCD42d1e2f2-9b9b-4a6d-9fc1-047e167153b54

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68016-010-816801600108130 TABLET, FILM COATED in 1 BLISTER PACK (68016-010-81) 2010-06-250000-00-00NoNoCurrent
68016-010-826801600108260 TABLET, FILM COATED in 1 BOTTLE (68016-010-82) 2010-06-250000-00-00NoNoCurrent