FDA.reportPublic FDA data

METOCLOPRAMIDE

Product NDC
51662-1670
11-digit product format
516621670
Labeler code
51662
Product ID
51662-1670_4f72ea58-0911-e0ba-e063-6394a90ad0ef
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
METOCLOPRAMIDE
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
HF Acquisition Co LLC, DBA HealthFirst
Application
ANDA073118
Marketing category
ANDA
Marketing start
2006-02-02
Substance
METOCLOPRAMIDE HYDROCHLORIDE
Active strength
5 mg/mL
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 HYDROCHLORIDE5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiW1792A2RVD
Rxcui311670

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
51662-1670-1METOCLOPRAMIDE2 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION22
51662-1670-2METOCLOPRAMIDE1 in 1 POUCHINJECTION, SOLUTION12
51662-1670-3METOCLOPRAMIDE25 in 1 CASEINJECTION, SOLUTION252

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311670metoclopramide 10 MG in 2 ML InjectionPSN4046830f-4b87-5e6e-e063-6394a90aeeb82
3116702 ML metoclopramide 5 MG/ML InjectionSCD4046830f-4b87-5e6e-e063-6394a90aeeb82
311670metoclopramide 10 MG per 2 ML InjectionSY4046830f-4b87-5e6e-e063-6394a90aeeb82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51662-1670-1516621670012 mL in 1 VIAL, SINGLE-DOSE2 mlHistorical
51662-1670-2516621670021 in 1 POUCHHistorical
51662-1670-35166216700325 POUCH in 1 CASE (51662-1670-3) / 1 VIAL, SINGLE-DOSE in 1 POUCH (51662-1670-2) / 2 mL in 1 VIAL, SINGLE-DOSE (51662-1670-1) 25 pouch2006-02-02NoNoCurrent