FDA.reportPublic FDA data

Metoclopramide Hydrochloride

Product NDC
42254-196
11-digit product format
422540196
Labeler code
42254
Product ID
42254-196_9af821c9-8182-469a-9ba9-430903d50bfb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoclopramide Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA072750
Marketing category
ANDA
Marketing start
2011-08-22
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
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
42254-196-302019-09-24C16284748780-19350213a-3d0a-c013-e053-90daa90a1393Metoclopramide Hydrochloride

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42254-196-30Metoclopramide Hydrochloride30 in 1 BOTTLE, PLASTICTABLET301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42254-196-30EA - Each42254-196e9e49e76-5a76-40b0-91dd-7a40145b80aa12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METOCLOPRAMIDE HYDROCHLORIDEACTIVE INGREDIENTW1792A2RVDMETOCLOPRAMIDE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
METOCLOPRAMIDEACTIVE MOIETYL4YEB44I46METOCLOPRAMIDE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933METOCLOPRAMIDE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKMETOCLOPRAMIDE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GMETOCLOPRAMIDE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDMETOCLOPRAMIDE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METOCLOPRAMIDE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EMETOCLOPRAMIDE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2METOCLOPRAMIDE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMETOCLOPRAMIDE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42254-196METOCLOPRAMIDE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20120511_9af821c9-8182-469a-9ba9-430903d50bfb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311668metoclopramide HCl 5 MG Oral TabletPSN9af821c9-8182-469a-9ba9-430903d50bfb1
311668metoclopramide 5 MG Oral TabletSCD9af821c9-8182-469a-9ba9-430903d50bfb1
311668metoclopramide 5 MG (as metoclopramide hydrochloride) Oral TabletSY9af821c9-8182-469a-9ba9-430903d50bfb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
42254-196-304225401963030 in 1 BOTTLE, PLASTICHistorical