FDA.reportPublic FDA data

Metoclopramide

Product NDC
83980-010
11-digit product format
839800010
Labeler code
83980
Product ID
83980-010_045886c5-5926-4d9e-a13c-8b0efc188862
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoclopramide
Dosage form
TABLET
Route
ORAL
Labeler
Ipca Laboratories Limited
Application
ANDA078807
Marketing category
ANDA
Marketing start
2025-01-09
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Metoclopramide
Listing expiration
2026-12-31

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
83980-010-01Metoclopramide100 in 1 BOTTLETABLET1002
83980-010-05Metoclopramide500 in 1 BOTTLETABLET5002
83980-010-10Metoclopramide1000 in 1 BOTTLETABLET10002
83980-010-13Metoclopramide30 in 1 BOTTLETABLET302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83980-010-01EA - Each83980-01076fde68f-94de-493c-b3e1-c8b85367231612025-03-04
83980-010-05EA - Each83980-010d1c38437-ad14-4ba5-9dd0-2faff8b726d712025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83980-010METOCLOPRAMIDE TABLET [IPCA LABORATORIES LIMITED]1Current NDC, 4 package rows20250110_c143e210-4ce7-44e5-b1e2-bf0e6bfde485.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311666metoclopramide HCl 10 MG Oral TabletPSNc143e210-4ce7-44e5-b1e2-bf0e6bfde4852
311668metoclopramide HCl 5 MG Oral TabletPSNc143e210-4ce7-44e5-b1e2-bf0e6bfde4852
311666metoclopramide 10 MG Oral TabletSCDc143e210-4ce7-44e5-b1e2-bf0e6bfde4852
311668metoclopramide 5 MG Oral TabletSCDc143e210-4ce7-44e5-b1e2-bf0e6bfde4852
311666metoclopramide (as metoclopramide HCl) 10 MG Oral TabletSYc143e210-4ce7-44e5-b1e2-bf0e6bfde4852
311668metoclopramide 5 MG (as metoclopramide hydrochloride) Oral TabletSYc143e210-4ce7-44e5-b1e2-bf0e6bfde4852

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83980-010-0183980001001100 TABLET in 1 BOTTLE (83980-010-01) 100 tablet2025-01-09NoNoCurrent
83980-010-0583980001005500 TABLET in 1 BOTTLE (83980-010-05) 500 tablet2025-01-09NoNoCurrent
83980-010-10839800010101000 TABLET in 1 BOTTLE (83980-010-10) 1000 tablet2025-01-09NoNoCurrent
83980-010-138398000101330 TABLET in 1 BOTTLE (83980-010-13) 30 tablet2025-01-09NoNoCurrent