FDA.reportPublic FDA data

CIMETIDINE

Product NDC
0440-1282
11-digit product format
004401282
Labeler code
0440
Product ID
0440-1282_e5d17d5a-fa9a-4175-bee8-97060d5338f1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CIMETIDINE
Dosage form
TABLET
Route
ORAL
Labeler
Liberty Pharmaceuticals, Inc.
Application
ANDA074890
Marketing category
ANDA
Marketing start
2010-11-24
Marketing end
0000-00-00
Substance
CIMETIDINE
Active strength
400 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
8f48ba86-02a3-4def-9efa-3a8140fd7adfProduct name220250624

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0440-1282-602020-01-31C16284748780-19d75b9cf-f251-f424-e053-dadaa90a57ceCimetidine

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0440-1282-60CIMETIDINE60 in 1 BOTTLE, PLASTICTABLET602

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CIMETIDINEACTIVE INGREDIENT80061L1WGDCIMETIDINE TABLET [LIBERTY PHARMACEUTICALS, INC.]2
CIMETIDINEACTIVE MOIETY80061L1WGDCIMETIDINE TABLET [LIBERTY PHARMACEUTICALS, INC.]2
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PCIMETIDINE TABLET [LIBERTY PHARMACEUTICALS, INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCIMETIDINE TABLET [LIBERTY PHARMACEUTICALS, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CIMETIDINE TABLET [LIBERTY PHARMACEUTICALS, INC.]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACIMETIDINE TABLET [LIBERTY PHARMACEUTICALS, INC.]2
POVIDONESINACTIVE INGREDIENTFZ989GH94ECIMETIDINE TABLET [LIBERTY PHARMACEUTICALS, INC.]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2CIMETIDINE TABLET [LIBERTY PHARMACEUTICALS, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCIMETIDINE TABLET [LIBERTY PHARMACEUTICALS, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCIMETIDINE TABLET [LIBERTY PHARMACEUTICALS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0440-1282CIMETIDINE TABLET [LIBERTY PHARMACEUTICALS, INC.]2Legacy NDC, 1 package rows20140228_5c7e51f9-37fd-4d79-ae4c-16cc772b72ed.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197507cimetidine 400 MG Oral TabletPSN5c7e51f9-37fd-4d79-ae4c-16cc772b72ed2
197507cimetidine 400 MG Oral TabletSCD5c7e51f9-37fd-4d79-ae4c-16cc772b72ed2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
0440-1282-600044012826060 in 1 BOTTLE, PLASTICHistorical