FDA.reportPublic FDA data

Metoclopramide

Product NDC
83634-779
11-digit product format
836340779
Labeler code
83634
Product ID
83634-779_d6819f4b-aff3-476c-9cb3-b20bd518dd99
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
metoclopramide hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Avenacy Inc.
Application
ANDA204756
Marketing category
ANDA
Marketing start
2024-06-30
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
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/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
83634-779-02Metoclopramide25 in 1 CARTONINJECTION, SOLUTION251
83634-779-41Metoclopramide2 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83634-779METOCLOPRAMIDE (METOCLOPRAMIDE HYDROCHLORIDE) INJECTION, SOLUTION [AVENACY INC.]1Current NDC, 2 package rows20240630_dc4a13f8-1e9b-4c75-82c0-bcd11f0a9a66.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311670metoclopramide 10 MG in 2 ML InjectionPSNdc4a13f8-1e9b-4c75-82c0-bcd11f0a9a661
3116702 ML metoclopramide 5 MG/ML InjectionSCDdc4a13f8-1e9b-4c75-82c0-bcd11f0a9a661
311670metoclopramide 10 MG per 2 ML InjectionSYdc4a13f8-1e9b-4c75-82c0-bcd11f0a9a661

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83634-779-028363407790225 VIAL, SINGLE-DOSE in 1 CARTON (83634-779-02) / 2 mL in 1 VIAL, SINGLE-DOSE (83634-779-41) 2024-06-30NoNoCurrent
83634-779-41836340779412 mL in 1 VIAL, SINGLE-DOSE2 mlHistorical