FDA.reportPublic FDA data

Metoclopramide

Product NDC
70518-1193
11-digit product format
705181193
Labeler code
70518
Product ID
70518-1193_5100cec6-743b-a75e-e063-6294a90a4826
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoclopramide
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA070184
Marketing category
ANDA
Marketing start
2018-05-14
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
70518-1193-0Metoclopramide60 in 1 BOTTLE, PLASTICTABLET6020
70518-1193-1Metoclopramide30 in 1 BLISTER PACKTABLET3020
70518-1193-2Metoclopramide100 in 1 BOXTABLET10020
70518-1193-3Metoclopramide1 in 1 POUCHTABLET120
70518-1193-4Metoclopramide10 in 1 BOTTLE, PLASTICTABLET1020
70518-1193-5Metoclopramide40 in 1 BOTTLE, PLASTICTABLET4020

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-1193METOCLOPRAMIDE TABLET [REMEDYREPACK INC.]14Current NDC, Legacy NDC, 6 package rows20250508_5d31d815-50fa-4e78-8ebd-affc2514ce78.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311666metoclopramide HCl 10 MG Oral TabletPSN5d31d815-50fa-4e78-8ebd-affc2514ce7820
311666metoclopramide 10 MG Oral TabletSCD5d31d815-50fa-4e78-8ebd-affc2514ce7820
311666metoclopramide (as metoclopramide HCl) 10 MG Oral TabletSY5d31d815-50fa-4e78-8ebd-affc2514ce7820

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-1193-07051811930060 TABLET in 1 BOTTLE, PLASTIC (70518-1193-0) 60 tablet2018-05-140000-00-00NoNoCurrent
70518-1193-17051811930130 TABLET in 1 BLISTER PACK (70518-1193-1) 30 tablet2021-05-120000-00-00NoNoCurrent
70518-1193-270518119302100 in 1 BOXHistorical
70518-1193-3705181193031 in 1 POUCHHistorical
70518-1193-47051811930410 in 1 BOTTLE, PLASTICHistorical
70518-1193-57051811930540 TABLET in 1 BOTTLE, PLASTIC (70518-1193-5) 40 tablet2025-11-18NoNoCurrent