FDA.reportPublic FDA data

Metoclopramide

Product NDC
72162-1750
11-digit product format
721621750
Labeler code
72162
Product ID
72162-1750_06eef2fa-547f-4bb6-bc94-825ea85e25c7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoclopramide
Dosage form
SOLUTION
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA071402
Marketing category
ANDA
Marketing start
2015-05-18
Substance
METOCLOPRAMIDE HYDROCHLORIDE
Active strength
5 mg/5mL
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/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiW1792A2RVD
Rxcui104884

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
72162-1750-2Metoclopramide473 mL in 1 BOTTLE, PLASTICSOLUTION473104
72162-1750-4Metoclopramide473 mL in 1 BOTTLE, PLASTICSOLUTION473104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1750-2ML - Milliliter72162-175096d36346-430a-43f5-841d-398460400baa12023-12-05
72162-1750-4ML - Milliliter72162-17504bf39ad8-6cdc-490f-8be9-062450accb2f12025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1750METOCLOPRAMIDE SOLUTION [BRYANT RANCH PREPACK]103Current NDC, 2 package rows20250207_9530014b-c266-4015-9195-9f100d67317b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
104884metoclopramide 5 MG in 5 mL Oral SolutionPSN9530014b-c266-4015-9195-9f100d67317b104
104884metoclopramide 1 MG/ML Oral SolutionSCD9530014b-c266-4015-9195-9f100d67317b104
104884metoclopramide (as the monohydrochloride monohydrate) 5 MG per 5 ML Oral SolutionSY9530014b-c266-4015-9195-9f100d67317b104
104884metoclopramide 5 MG per 5 ML Oral SolutionSY9530014b-c266-4015-9195-9f100d67317b104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-1750-272162175002473 mL in 1 BOTTLE, PLASTIC (72162-1750-2) 473 ml2023-10-06NoNoCurrent
72162-1750-472162175004473 mL in 1 BOTTLE, PLASTIC (72162-1750-4) 473 ml2023-10-06NoNoCurrent