Famotidine - Acid Controller

Product NDC
51660-036
11-digit product format
516600036
Labeler code
51660
Product ID
51660-036_04ac9d5d-6606-4157-a71e-d5762d391ee8
Type
HUMAN OTC DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Ohm Laboratories Inc.
Application
ANDA090283
Marketing category
ANDA
Marketing start
2017-05-31
Marketing end
0000-00-00
Substance
FAMOTIDINE
Active strength
20 mg/1
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51660-036-262020-01-31C16284748780-19d75b9d0-9acf-f424-e053-dadaa90a57ce653c165e-3e22-4796-b170-cc87547574c4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51660-036-26EA - Each51660-036f37e497d-acc0-44c5-920d-3dec848d9e3512019-03-12
51660-036-50EA - Each51660-036ffb86c67-4b3c-414b-bb42-e707b886a67512019-03-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FAMOTIDINEACTIVE INGREDIENT5QZO15J2Z8FAMOTIDINE - ACID CONTROLLER (FAMOTIDINE) TABLET, FILM COATED [OHM LABORATORIES INC.]4
FAMOTIDINEACTIVE MOIETY5QZO15J2Z8FAMOTIDINE - ACID CONTROLLER (FAMOTIDINE) TABLET, FILM COATED [OHM LABORATORIES INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFAMOTIDINE - ACID CONTROLLER (FAMOTIDINE) TABLET, FILM COATED [OHM LABORATORIES INC.]4
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FAMOTIDINE - ACID CONTROLLER (FAMOTIDINE) TABLET, FILM COATED [OHM LABORATORIES INC.]4
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675FAMOTIDINE - ACID CONTROLLER (FAMOTIDINE) TABLET, FILM COATED [OHM LABORATORIES INC.]4
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PFAMOTIDINE - ACID CONTROLLER (FAMOTIDINE) TABLET, FILM COATED [OHM LABORATORIES INC.]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOFAMOTIDINE - ACID CONTROLLER (FAMOTIDINE) TABLET, FILM COATED [OHM LABORATORIES INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FAMOTIDINE - ACID CONTROLLER (FAMOTIDINE) TABLET, FILM COATED [OHM LABORATORIES INC.]4
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQFAMOTIDINE - ACID CONTROLLER (FAMOTIDINE) TABLET, FILM COATED [OHM LABORATORIES INC.]4
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJFAMOTIDINE - ACID CONTROLLER (FAMOTIDINE) TABLET, FILM COATED [OHM LABORATORIES INC.]4
TALCINACTIVE INGREDIENT7SEV7J4R1UFAMOTIDINE - ACID CONTROLLER (FAMOTIDINE) TABLET, FILM COATED [OHM LABORATORIES INC.]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFAMOTIDINE - ACID CONTROLLER (FAMOTIDINE) TABLET, FILM COATED [OHM LABORATORIES INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51660-036FAMOTIDINE - ACID CONTROLLER (FAMOTIDINE) TABLET, FILM COATED [OHM LABORATORIES INC.]6Legacy NDC20171116_653c165e-3e22-4796-b170-cc87547574c4.zip