FDA.reportPublic FDA data

Metoclopramide Hydrochloride

Product NDC
43353-808
11-digit product format
433530808
Labeler code
43353
Product ID
43353-808_24332066-8223-4d5c-8957-5c69a287249e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoclopramide Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA071250
Marketing category
ANDA
Marketing start
2011-08-22
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
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
43353-808-532020-01-31C16284748780-19d75b9cf-f81b-f424-e053-dadaa90a57ceMetoclopramide Hydrochloride
43353-808-602020-01-31C16284748780-19d75b9cf-f81b-f424-e053-dadaa90a57ceMetoclopramide Hydrochloride
43353-808-802020-01-31C16284748780-19d75b9cf-f81b-f424-e053-dadaa90a57ceMetoclopramide Hydrochloride

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43353-808-53Metoclopramide Hydrochloride60 in 1 BOTTLE, PLASTICTABLET601
43353-808-60Metoclopramide Hydrochloride90 in 1 BOTTLE, PLASTICTABLET901
43353-808-80Metoclopramide Hydrochloride180 in 1 BOTTLE, PLASTICTABLET1801

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-808-53EA - Each43353-8085663725f-312d-44d6-a92f-c1d74932cd7412015-05-05
43353-808-60EA - Each43353-808f7ec5b86-0f0a-4bf4-b7bf-6b980911e34612016-06-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METOCLOPRAMIDE HYDROCHLORIDEACTIVE INGREDIENTW1792A2RVDMETOCLOPRAMIDE HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
METOCLOPRAMIDEACTIVE MOIETYL4YEB44I46METOCLOPRAMIDE HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKMETOCLOPRAMIDE HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METOCLOPRAMIDE HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EMETOCLOPRAMIDE HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2METOCLOPRAMIDE HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMETOCLOPRAMIDE HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-808METOCLOPRAMIDE HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC, 3 package rows20140513_1fd92b83-ffcc-4b59-a2d5-13c9ea49bafd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311666metoclopramide HCl 10 MG Oral TabletPSN1fd92b83-ffcc-4b59-a2d5-13c9ea49bafd1
311666metoclopramide 10 MG Oral TabletSCD1fd92b83-ffcc-4b59-a2d5-13c9ea49bafd1
311666metoclopramide (as metoclopramide HCl) 10 MG Oral TabletSY1fd92b83-ffcc-4b59-a2d5-13c9ea49bafd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
43353-808-534335308085360 in 1 BOTTLE, PLASTICHistorical
43353-808-604335308086090 in 1 BOTTLE, PLASTICHistorical
43353-808-8043353080880180 in 1 BOTTLE, PLASTICHistorical