FDA.reportPublic FDA data

METOCLOPRAMIDE hydrochloride

Product NDC
40032-580
11-digit product format
400320580
Labeler code
40032
Product ID
40032-580_6560c273-018b-4668-8c95-f5fd1fe77998
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoclopramide Hydrochloride
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Novel Laboratories, Inc.
Application
ANDA202191
Marketing category
ANDA
Marketing start
2014-08-15
Marketing end
0000-00-00
Substance
METOCLOPRAMIDE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
86441fd8-22b8-41db-bb26-c70dffc3923bProduct name120210111
340a6817-217a-4b71-9e83-8e2e60c4b0c5Product name120150319
1f2c49ec-0a44-8021-ecde-b27ece080b13Product name120140508
46471181-3fa6-5fcd-1d9f-1bb9d2b06171Product name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
40032-580-312020-01-31C16284748780-19d75b9d0-f445-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use METOCLOPRAMIDE hydrochloride safely and effectively. See full prescribing information for METOCLOPRAMIDE hydrochloride. METOCLOPRAMIDE hydrochloride (Metoclopramide Hydrochloride) TABLET, ORALLY DISINTEGRATING for ORAL use. Initial U.S. Approval: 1976

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
40032-580-31METOCLOPRAMIDE hydrochloride10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING106
40032-580-31METOCLOPRAMIDE hydrochloride10 in 1 CARTONTABLET, ORALLY DISINTEGRATING106

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METOCLOPRAMIDE HYDROCHLORIDEACTIVE INGREDIENTW1792A2RVDMETOCLOPRAMIDE HYDROCHLORIDE TABLET, ORALLY DISINTEGRATING [NOVEL LABORATORIES, INC.]5
METOCLOPRAMIDEACTIVE MOIETYL4YEB44I46METOCLOPRAMIDE HYDROCHLORIDE TABLET, ORALLY DISINTEGRATING [NOVEL LABORATORIES, INC.]5
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1METOCLOPRAMIDE HYDROCHLORIDE TABLET, ORALLY DISINTEGRATING [NOVEL LABORATORIES, INC.]5
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2UMETOCLOPRAMIDE HYDROCHLORIDE TABLET, ORALLY DISINTEGRATING [NOVEL LABORATORIES, INC.]5
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KMETOCLOPRAMIDE HYDROCHLORIDE TABLET, ORALLY DISINTEGRATING [NOVEL LABORATORIES, INC.]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMETOCLOPRAMIDE HYDROCHLORIDE TABLET, ORALLY DISINTEGRATING [NOVEL LABORATORIES, INC.]5
CROSPOVIDONEINACTIVE INGREDIENT68401960MKMETOCLOPRAMIDE HYDROCHLORIDE TABLET, ORALLY DISINTEGRATING [NOVEL LABORATORIES, INC.]5
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMERINACTIVE INGREDIENT905HNO1SIHMETOCLOPRAMIDE HYDROCHLORIDE TABLET, ORALLY DISINTEGRATING [NOVEL LABORATORIES, INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METOCLOPRAMIDE HYDROCHLORIDE TABLET, ORALLY DISINTEGRATING [NOVEL LABORATORIES, INC.]5
MANNITOLINACTIVE INGREDIENT3OWL53L36AMETOCLOPRAMIDE HYDROCHLORIDE TABLET, ORALLY DISINTEGRATING [NOVEL LABORATORIES, INC.]5
PHOSPHORIC ACIDINACTIVE INGREDIENTE4GA8884NNMETOCLOPRAMIDE HYDROCHLORIDE TABLET, ORALLY DISINTEGRATING [NOVEL LABORATORIES, INC.]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4METOCLOPRAMIDE HYDROCHLORIDE TABLET, ORALLY DISINTEGRATING [NOVEL LABORATORIES, INC.]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMETOCLOPRAMIDE HYDROCHLORIDE TABLET, ORALLY DISINTEGRATING [NOVEL LABORATORIES, INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
40032-580METOCLOPRAMIDE HYDROCHLORIDE TABLET, ORALLY DISINTEGRATING [NOVEL LABORATORIES, INC.]6Legacy NDC, 2 package rows20171228_3fb9a45e-48ba-45c5-86a7-03a8744888f6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
608623metoclopramide HCl 10 MG Disintegrating Oral TabletPSN3fb9a45e-48ba-45c5-86a7-03a8744888f66
608624metoclopramide HCl 5 MG Disintegrating Oral TabletPSN3fb9a45e-48ba-45c5-86a7-03a8744888f66
608623metoclopramide 10 MG Disintegrating Oral TabletSCD3fb9a45e-48ba-45c5-86a7-03a8744888f66
608624metoclopramide 5 MG Disintegrating Oral TabletSCD3fb9a45e-48ba-45c5-86a7-03a8744888f66
608623metoclopramide 10 MG (metoclopramide hydrochloride 11.82 MG) Disintegrating Oral TabletSY3fb9a45e-48ba-45c5-86a7-03a8744888f66
608624metoclopramide 5 MG (as metoclopramide HCl 5.91 MG) Disintegrating Oral TabletSY3fb9a45e-48ba-45c5-86a7-03a8744888f66

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
40032-580-314003205803110 in 1 BLISTER PACKHistorical