FDA.reportPublic FDA data

Metoclopramide

Product NDC
60687-837
11-digit product format
606870837
Labeler code
60687
Product ID
60687-837_328399bd-5afb-f961-e063-6294a90a7c0a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoclopramide
Dosage form
SOLUTION
Route
ORAL
Labeler
American Health Packaging
Application
ANDA071402
Marketing category
ANDA
Marketing start
2024-11-12
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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
86441fd8-22b8-41db-bb26-c70dffc3923bProduct name120210111
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
340a6817-217a-4b71-9e83-8e2e60c4b0c5Product name120150319
1f2c49ec-0a44-8021-ecde-b27ece080b13Product name120140508
46471181-3fa6-5fcd-1d9f-1bb9d2b06171Product name120140508
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60687-837-42Metoclopramide10 mL in 1 CUP, UNIT-DOSESOLUTION104
60687-837-48Metoclopramide10 in 1 TRAYSOLUTION104
60687-837-56Metoclopramide10 in 1 CASESOLUTION104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-837-42ML - Milliliter60687-8374e4153b5-506d-463a-9323-f96e1449159e12024-10-04
60687-837-56ML - Milliliter60687-837f1d8bf85-9d0c-4f65-8c46-f8a74414156612024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-837METOCLOPRAMIDE SOLUTION [AMERICAN HEALTH PACKAGING]4Current NDC, 3 package rows20250413_0034a97a-fb05-418a-a234-de278907cd2a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
104884metoclopramide 5 MG in 5 mL Oral SolutionPSN0034a97a-fb05-418a-a234-de278907cd2a4
104884metoclopramide 1 MG/ML Oral SolutionSCD0034a97a-fb05-418a-a234-de278907cd2a4
104884metoclopramide (as the monohydrochloride monohydrate) 5 MG per 5 ML Oral SolutionSY0034a97a-fb05-418a-a234-de278907cd2a4
104884metoclopramide 5 MG per 5 ML Oral SolutionSY0034a97a-fb05-418a-a234-de278907cd2a4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60687-837-426068708374210 mL in 1 CUP, UNIT-DOSE10 mlHistorical
60687-837-486068708374810 in 1 TRAYHistorical
60687-837-566068708375610 TRAY in 1 CASE (60687-837-56) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-837-48) / 10 mL in 1 CUP, UNIT-DOSE (60687-837-42) 10 tray2024-11-12NoNoHistorical