FDA.reportPublic FDA data

Metoclopramide

Product NDC
50228-233
11-digit product format
502280233
Labeler code
50228
Product ID
50228-233_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
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, 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
50228-233-01Metoclopramide100 in 1 BOTTLETABLET1005
50228-233-05Metoclopramide500 in 1 BOTTLETABLET5005
50228-233-10Metoclopramide1000 in 1 BOTTLETABLET10005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50228-233-01EA - Each50228-233886af3f6-7171-485f-9bdf-cda39a08a38612025-06-13
50228-233-05EA - Each50228-2330e9d5ac4-4c52-4e97-af33-c1fa72d8600612025-06-13
50228-233-10EA - Each50228-23332472eb9-83d0-4163-93d1-455b25d5739d12025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50228-233METOCLOPRAMIDE TABLET [SCIEGEN PHARMACEUTICALS, INC.]3Current NDC, 3 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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50228-233-0150228023301100 TABLET in 1 BOTTLE (50228-233-01) 100 tablet2025-02-12NoNoCurrent
50228-233-0550228023305500 TABLET in 1 BOTTLE (50228-233-05) 500 tablet2025-02-12NoNoCurrent
50228-233-10502280233101000 TABLET in 1 BOTTLE (50228-233-10) 1000 tablet2025-02-12NoNoCurrent