FDA.reportPublic FDA data

Metoclopramide Hydrochloride

Product NDC
53808-0623
11-digit product format
538080623
Labeler code
53808
Product ID
53808-0623_a995488f-2f37-47fa-9315-d75d407160db
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoclopramide Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
State of Florida DOH Central Pharmacy
Application
ANDA071250
Marketing category
ANDA
Marketing start
2013-01-01
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
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
53808-0623-12020-01-31C16284748780-19d75b9cf-f770-f424-e053-dadaa90a57ceMetoclopramide Hydrochloride

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53808-0623-1Metoclopramide Hydrochloride30 in 1 BLISTER PACKTABLET301

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METOCLOPRAMIDE HYDROCHLORIDEACTIVE INGREDIENTW1792A2RVDMETOCLOPRAMIDE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
METOCLOPRAMIDEACTIVE MOIETYL4YEB44I46METOCLOPRAMIDE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKMETOCLOPRAMIDE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METOCLOPRAMIDE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EMETOCLOPRAMIDE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2METOCLOPRAMIDE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMETOCLOPRAMIDE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-0623METOCLOPRAMIDE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1Legacy NDC, 1 package rows20140415_76de537b-97f5-4824-b49d-65cc4653c30b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311666metoclopramide HCl 10 MG Oral TabletPSN76de537b-97f5-4824-b49d-65cc4653c30b1
311666metoclopramide 10 MG Oral TabletSCD76de537b-97f5-4824-b49d-65cc4653c30b1
311666metoclopramide (as metoclopramide HCl) 10 MG Oral TabletSY76de537b-97f5-4824-b49d-65cc4653c30b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53808-0623-15380806230130 in 1 BLISTER PACKHistorical