FDA.reportPublic FDA data

Metoclopramide

Product NDC
50090-2221
11-digit product format
500902221
Labeler code
50090
Product ID
50090-2221_76eb0ce6-1158-42a4-a390-63cfe2663204
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoclopramide
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA070581
Marketing category
ANDA
Marketing start
1985-10-17
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
2022-12-31
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
50090-2221-02023-01-30C16284748780-1f386c649-ca43-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use METOCLOPRAMIDE TABLETS safely and effectively. See full prescribing information for METOCLOPRAMIDE TABLETS. METOCLOPRAMIDE tablets, for oral use Initial U.S. Approval: 1979

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-2221-0Metoclopramide30 in 1 BOTTLETABLET308

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2221-0EA - Each50090-2221aa39564f-617a-4c78-8d07-3005ab100eeb12019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2221METOCLOPRAMIDE TABLET [A-S MEDICATION SOLUTIONS]8Legacy NDC, 1 package rows20210617_e75c1a34-b15c-4919-afa1-c24c5e759d4b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311666metoclopramide HCl 10 MG Oral TabletPSNe75c1a34-b15c-4919-afa1-c24c5e759d4b8
311666metoclopramide 10 MG Oral TabletSCDe75c1a34-b15c-4919-afa1-c24c5e759d4b8
311666metoclopramide (as metoclopramide HCl) 10 MG Oral TabletSYe75c1a34-b15c-4919-afa1-c24c5e759d4b8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-2221-05009022210030 TABLET in 1 BOTTLE (50090-2221-0) 30 tablet2015-11-060000-00-00NoNoCurrent