FDA.reportPublic FDA data

Metoclopramide

Product NDC
50228-232
11-digit product format
502280232
Labeler code
50228
Product ID
50228-232_50b47676-8433-bfb9-e063-6394a90a124c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoclopramide
Dosage form
TABLET
Route
ORAL
Labeler
ScieGen Pharmaceuticals, Inc.
Application
ANDA072215
Marketing category
ANDA
Marketing start
2025-02-12
Substance
METOCLOPRAMIDE HYDROCHLORIDE
Active strength
5 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 HYDROCHLORIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiW1792A2RVD
Rxcui311666, 311668

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
50228-232-01Metoclopramide100 in 1 BOTTLETABLET1005
50228-232-05Metoclopramide500 in 1 BOTTLETABLET5005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50228-232-01EA - Each50228-2321f1bb29d-84ea-4947-9d6c-9b229a522bc412025-06-13
50228-232-05EA - Each50228-232202330ab-3c1b-4126-a145-be1de95b8af812025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50228-232METOCLOPRAMIDE TABLET [SCIEGEN PHARMACEUTICALS, INC.]3Current NDC, 2 package rows20250508_b16ad17c-eeea-407e-91e4-36506e9aa698.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311666metoclopramide HCl 10 MG Oral TabletPSNb16ad17c-eeea-407e-91e4-36506e9aa6985
311668metoclopramide HCl 5 MG Oral TabletPSNb16ad17c-eeea-407e-91e4-36506e9aa6985
311666metoclopramide 10 MG Oral TabletSCDb16ad17c-eeea-407e-91e4-36506e9aa6985
311668metoclopramide 5 MG Oral TabletSCDb16ad17c-eeea-407e-91e4-36506e9aa6985
311666metoclopramide (as metoclopramide HCl) 10 MG Oral TabletSYb16ad17c-eeea-407e-91e4-36506e9aa6985
311668metoclopramide 5 MG (as metoclopramide hydrochloride) Oral TabletSYb16ad17c-eeea-407e-91e4-36506e9aa6985
311668metoclopramide HCl 5 MG Oral TabletPSN45250bbc-d079-c362-e063-6294a90a56e01
311668metoclopramide 5 MG Oral TabletSCD45250bbc-d079-c362-e063-6294a90a56e01
311668metoclopramide 5 MG (as metoclopramide hydrochloride) Oral TabletSY45250bbc-d079-c362-e063-6294a90a56e01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50228-232-0150228023201100 TABLET in 1 BOTTLE (50228-232-01) 100 tablet2025-02-12NoNoCurrent
50228-232-0550228023205500 TABLET in 1 BOTTLE (50228-232-05) 500 tablet2025-02-12NoNoCurrent