FDA.reportPublic FDA data

Metoclopramide

Product NDC
51655-240
11-digit product format
516550240
Labeler code
51655
Product ID
51655-240_48d2d970-b305-2ef9-e063-6394a90a324a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoclopramide
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA070184
Marketing category
ANDA
Marketing start
2022-10-06
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Metoclopramide
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METOCLOPRAMIDE HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiW1792A2RVD
Rxcui311666

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51655-240-52Metoclopramide30 in 1 BOTTLE, PLASTICTABLET303
51655-240-87Metoclopramide6 in 1 BOTTLE, PLASTICTABLET63

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-240METOCLOPRAMIDE TABLET [NORTHWIND PHARMACEUTICALS, LLC]2Current NDC, 2 package rows20240110_f2b732ab-b859-7252-e053-2995a90af0d8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311666metoclopramide HCl 10 MG Oral TabletPSNf2b732ab-b859-7252-e053-2995a90af0d83
311666metoclopramide 10 MG Oral TabletSCDf2b732ab-b859-7252-e053-2995a90af0d83
311666metoclopramide (as metoclopramide HCl) 10 MG Oral TabletSYf2b732ab-b859-7252-e053-2995a90af0d83

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51655-240-525165502405230 TABLET in 1 BOTTLE, PLASTIC (51655-240-52) 30 tablet2022-10-06NoNoCurrent
51655-240-87516550240876 TABLET in 1 BOTTLE, PLASTIC (51655-240-87) 6 tablet2023-12-26NoNoCurrent