FDA.reportPublic FDA data

Metoclopramide

Product NDC
71335-1259
11-digit product format
713351259
Labeler code
71335
Product ID
71335-1259_e2c63d5f-9d75-4e3d-9278-dbffa09fd944
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoclopramide
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA072801
Marketing category
ANDA
Marketing start
1993-07-01
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
Rxcui311668

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
71335-1259-1Metoclopramide30 in 1 BOTTLETABLET30100
71335-1259-2Metoclopramide120 in 1 BOTTLETABLET120100
71335-1259-3Metoclopramide90 in 1 BOTTLETABLET90100
71335-1259-4Metoclopramide60 in 1 BOTTLETABLET60100
71335-1259-5Metoclopramide100 in 1 BOTTLETABLET100100

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1259METOCLOPRAMIDE TABLET [BRYANT RANCH PREPACK]100Current NDC, Legacy NDC, 5 package rows20240526_6f0a13cc-9346-4f4a-9a0d-b725045b01aa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311668metoclopramide HCl 5 MG Oral TabletPSN6f0a13cc-9346-4f4a-9a0d-b725045b01aa100
311668metoclopramide 5 MG Oral TabletSCD6f0a13cc-9346-4f4a-9a0d-b725045b01aa100
311668metoclopramide 5 MG (as metoclopramide hydrochloride) Oral TabletSY6f0a13cc-9346-4f4a-9a0d-b725045b01aa100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1259-17133512590130 TABLET in 1 BOTTLE (71335-1259-1) 30 tablet2024-05-240000-00-00NoNoCurrent
71335-1259-271335125902120 TABLET in 1 BOTTLE (71335-1259-2) 120 tablet2024-05-240000-00-00NoNoCurrent
71335-1259-37133512590390 TABLET in 1 BOTTLE (71335-1259-3) 90 tablet2024-05-240000-00-00NoNoCurrent
71335-1259-47133512590460 TABLET in 1 BOTTLE (71335-1259-4) 60 tablet2024-05-240000-00-00NoNoCurrent
71335-1259-571335125905100 TABLET in 1 BOTTLE (71335-1259-5) 100 tablet2024-05-240000-00-00NoNoCurrent