FDA.reportPublic FDA data

Metoclopramide

Product NDC
21695-346
11-digit product format
216950346
Labeler code
21695
Product ID
21695-346_f32d6e27-5b7b-4b17-af2e-0250447ee560
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoclopramide
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors Corp.
Application
ANDA071250
Marketing category
ANDA
Marketing start
2006-01-01
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
E
Listing certified through
2017-12-31
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
21695-346-152019-09-24C16284748780-1934fe258-4722-48b1-e053-8cdaa90a720aMETOCLOPRAMIDE TABLETS, USP
21695-346-202019-09-24C16284748780-1934fe258-4722-48b1-e053-8cdaa90a720aMETOCLOPRAMIDE TABLETS, USP
21695-346-302019-09-24C16284748780-1934fe258-4722-48b1-e053-8cdaa90a720aMETOCLOPRAMIDE TABLETS, USP
21695-346-602019-09-24C16284748780-1934fe258-4722-48b1-e053-8cdaa90a720aMETOCLOPRAMIDE TABLETS, USP
21695-346-902019-09-24C16284748780-1934fe258-4722-48b1-e053-8cdaa90a720aMETOCLOPRAMIDE TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-346-15Metoclopramide15 in 1 BOTTLETABLET151
21695-346-20Metoclopramide20 in 1 BOTTLETABLET201
21695-346-30Metoclopramide30 in 1 BOTTLETABLET301
21695-346-60Metoclopramide60 in 1 BOTTLETABLET601
21695-346-90Metoclopramide90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-346-15EA - Each21695-3463dde3514-809e-460c-86f9-e441e3d0ddd912012-07-24
21695-346-20EA - Each21695-346ff899d0f-3846-46c5-9efe-88f2dcf9a85212012-07-24
21695-346-30EA - Each21695-346bbb9ce82-af4a-495e-89c4-186286b0437312012-07-24
21695-346-60EA - Each21695-34678523836-b9fe-4166-9538-595a3910583a12012-07-24
21695-346-90EA - Each21695-34630eaa1cd-4779-4397-9ea6-19113b7ad15f12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METOCLOPRAMIDE HYDROCHLORIDEACTIVE INGREDIENTW1792A2RVDMETOCLOPRAMIDE TABLET [REBEL DISTRIBUTORS CORP.]1
METOCLOPRAMIDEACTIVE MOIETYL4YEB44I46METOCLOPRAMIDE TABLET [REBEL DISTRIBUTORS CORP.]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKMETOCLOPRAMIDE TABLET [REBEL DISTRIBUTORS CORP.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GMETOCLOPRAMIDE TABLET [REBEL DISTRIBUTORS CORP.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDMETOCLOPRAMIDE TABLET [REBEL DISTRIBUTORS CORP.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METOCLOPRAMIDE TABLET [REBEL DISTRIBUTORS CORP.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EMETOCLOPRAMIDE TABLET [REBEL DISTRIBUTORS CORP.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2METOCLOPRAMIDE TABLET [REBEL DISTRIBUTORS CORP.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMETOCLOPRAMIDE TABLET [REBEL DISTRIBUTORS CORP.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-346METOCLOPRAMIDE TABLET [REBEL DISTRIBUTORS CORP.]1Legacy NDC, 5 package rows20101201_f32d6e27-5b7b-4b17-af2e-0250447ee560.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311666metoclopramide HCl 10 MG Oral TabletPSNf32d6e27-5b7b-4b17-af2e-0250447ee5601
311668metoclopramide HCl 5 MG Oral TabletPSNf32d6e27-5b7b-4b17-af2e-0250447ee5601
311666metoclopramide 10 MG Oral TabletSCDf32d6e27-5b7b-4b17-af2e-0250447ee5601
311668metoclopramide 5 MG Oral TabletSCDf32d6e27-5b7b-4b17-af2e-0250447ee5601
311666metoclopramide (as metoclopramide HCl) 10 MG Oral TabletSYf32d6e27-5b7b-4b17-af2e-0250447ee5601
311668metoclopramide 5 MG (as metoclopramide hydrochloride) Oral TabletSYf32d6e27-5b7b-4b17-af2e-0250447ee5601

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-346-152169503461515 in 1 BOTTLEHistorical
21695-346-202169503462020 in 1 BOTTLEHistorical
21695-346-302169503463030 in 1 BOTTLEHistorical
21695-346-602169503466060 in 1 BOTTLEHistorical
21695-346-902169503469090 in 1 BOTTLEHistorical