FDA.reportPublic FDA data

Metoclopramide

Product NDC
51079-888
11-digit product format
510790888
Labeler code
51079
Product ID
51079-888_3a866de8-d779-26e4-e063-6294a90abf6b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoclopramide
Dosage form
TABLET
Route
ORAL
Labeler
Mylan Institutional Inc.
Application
ANDA070184
Marketing category
ANDA
Marketing start
2014-01-02
Substance
METOCLOPRAMIDE HYDROCHLORIDE
Active strength
10 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 HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiW1792A2RVD
Rxcui311666, 311668

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
51079-888-01Metoclopramide1 in 1 BLISTER PACKTABLET112
51079-888-20Metoclopramide100 in 1 CARTONTABLET10012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51079-888-01EA - Each51079-8886297ca1e-cfc6-4d1c-a042-435c800448a312014-07-02
51079-888-19EA - Each51079-888daa95d89-9b71-478c-8d55-bcd6fd04206e12014-07-02
51079-888-20EA - Each51079-888439f34de-322e-4790-8b78-0c796652c25a12014-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METOCLOPRAMIDE HYDROCHLORIDEACTIVE INGREDIENTW1792A2RVDMETOCLOPRAMIDE TABLET [MYLAN INSTITUTIONAL INC.]1
METOCLOPRAMIDEACTIVE MOIETYL4YEB44I46METOCLOPRAMIDE TABLET [MYLAN INSTITUTIONAL INC.]1
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JMETOCLOPRAMIDE TABLET [MYLAN INSTITUTIONAL INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMETOCLOPRAMIDE TABLET [MYLAN INSTITUTIONAL INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METOCLOPRAMIDE TABLET [MYLAN INSTITUTIONAL INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2METOCLOPRAMIDE TABLET [MYLAN INSTITUTIONAL INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMETOCLOPRAMIDE TABLET [MYLAN INSTITUTIONAL INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51079-888METOCLOPRAMIDE TABLET [MYLAN INSTITUTIONAL INC.]11Current NDC, Legacy NDC, 2 package rows20241013_447dbb34-7903-4e6a-be31-48a0b0e0d2f5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311666metoclopramide HCl 10 MG Oral TabletPSN447dbb34-7903-4e6a-be31-48a0b0e0d2f512
311668metoclopramide HCl 5 MG Oral TabletPSN447dbb34-7903-4e6a-be31-48a0b0e0d2f512
311666metoclopramide 10 MG Oral TabletSCD447dbb34-7903-4e6a-be31-48a0b0e0d2f512
311668metoclopramide 5 MG Oral TabletSCD447dbb34-7903-4e6a-be31-48a0b0e0d2f512
311666metoclopramide (as metoclopramide HCl) 10 MG Oral TabletSY447dbb34-7903-4e6a-be31-48a0b0e0d2f512
311668metoclopramide 5 MG (as metoclopramide hydrochloride) Oral TabletSY447dbb34-7903-4e6a-be31-48a0b0e0d2f512

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51079-888-01510790888011 in 1 BLISTER PACKHistorical
51079-888-2051079088820100 BLISTER PACK in 1 CARTON (51079-888-20) / 1 TABLET in 1 BLISTER PACK (51079-888-01) 100 blister pack2014-01-020000-00-00NoNoCurrent