FDA.reportPublic FDA data

METOCLOPRAMIDE HYDROCHLORIDE

Product NDC
61919-150
11-digit product format
619190150
Labeler code
61919
Product ID
61919-150_9c993997-4847-41af-e053-2995a90ab890
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
METOCLOPRAMIDE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
DIRECT RX
Application
ANDA072801
Marketing category
ANDA
Marketing start
2014-01-01
Marketing end
0000-00-00
Substance
METOCLOPRAMIDE HYDROCHLORIDE
Active strength
5 mg/1
Pharmacologic classes
Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
86441fd8-22b8-41db-bb26-c70dffc3923bProduct name120210111
340a6817-217a-4b71-9e83-8e2e60c4b0c5Product name120150319
1f2c49ec-0a44-8021-ecde-b27ece080b13Product name120140508
46471181-3fa6-5fcd-1d9f-1bb9d2b06171Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-150-902023-01-30C16284748780-1f386c649-bedb-0266-e053-dadaa90a7c1aMETOCLOPRAMIDE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-150-90METOCLOPRAMIDE HYDROCHLORIDE90 in 1 BOTTLETABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-150-90EA - Each61919-150a4a4f1c3-08ec-4060-af4b-6a818c59bf0712015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METOCLOPRAMIDE HYDROCHLORIDEACTIVE INGREDIENTW1792A2RVDMETOCLOPRAMIDE HYDROCHLORIDE TABLET [DIRECT RX]1
METOCLOPRAMIDEACTIVE MOIETYL4YEB44I46METOCLOPRAMIDE HYDROCHLORIDE TABLET [DIRECT RX]1
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JMETOCLOPRAMIDE HYDROCHLORIDE TABLET [DIRECT RX]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMETOCLOPRAMIDE HYDROCHLORIDE TABLET [DIRECT RX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METOCLOPRAMIDE HYDROCHLORIDE TABLET [DIRECT RX]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2METOCLOPRAMIDE HYDROCHLORIDE TABLET [DIRECT RX]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMETOCLOPRAMIDE HYDROCHLORIDE TABLET [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-150METOCLOPRAMIDE HYDROCHLORIDE TABLET [DIRECT RX]3Legacy NDC, 1 package rows20200121_1c714687-2ed3-4da0-b6e4-4fbc207d480b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311668metoclopramide HCl 5 MG Oral TabletPSN1c714687-2ed3-4da0-b6e4-4fbc207d480b3
311668metoclopramide 5 MG Oral TabletSCD1c714687-2ed3-4da0-b6e4-4fbc207d480b3
311668metoclopramide 5 MG (as metoclopramide hydrochloride) Oral TabletSY1c714687-2ed3-4da0-b6e4-4fbc207d480b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-150-906191901509090 TABLET in 1 BOTTLE (61919-150-90) 90 tablet2015-01-010000-00-00NoNoCurrent