FDA.reportPublic FDA data

Metoclopramide

Product NDC
63187-235
11-digit product format
631870235
Labeler code
63187
Product ID
63187-235_99c5f2dc-5112-4a12-9d4e-cdd0f4936ec1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoclopramide
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA070184
Marketing category
ANDA
Marketing start
1990-09-30
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
63187-235-12Metoclopramide12 in 1 BOTTLETABLET126
63187-235-30Metoclopramide30 in 1 BOTTLETABLET306
63187-235-60Metoclopramide60 in 1 BOTTLETABLET606
63187-235-90Metoclopramide90 in 1 BOTTLETABLET906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-235-30EA - Each63187-235004a00ef-fc6f-4aee-9c13-d8a46aeedcc712026-02-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METOCLOPRAMIDE HYDROCHLORIDEACTIVE INGREDIENTW1792A2RVDMETOCLOPRAMIDE TABLET [PROFICIENT RX LP]3
METOCLOPRAMIDEACTIVE MOIETYL4YEB44I46METOCLOPRAMIDE TABLET [PROFICIENT RX LP]3
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JMETOCLOPRAMIDE TABLET [PROFICIENT RX LP]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMETOCLOPRAMIDE TABLET [PROFICIENT RX LP]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METOCLOPRAMIDE TABLET [PROFICIENT RX LP]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2METOCLOPRAMIDE TABLET [PROFICIENT RX LP]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMETOCLOPRAMIDE TABLET [PROFICIENT RX LP]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-235METOCLOPRAMIDE TABLET [PROFICIENT RX LP]6Current NDC, Legacy NDC, 4 package rows20230204_ce367a41-89d3-45c2-aac2-36fce43062d0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311666metoclopramide HCl 10 MG Oral TabletPSNce367a41-89d3-45c2-aac2-36fce43062d06
311668metoclopramide HCl 5 MG Oral TabletPSNce367a41-89d3-45c2-aac2-36fce43062d06
311666metoclopramide 10 MG Oral TabletSCDce367a41-89d3-45c2-aac2-36fce43062d06
311668metoclopramide 5 MG Oral TabletSCDce367a41-89d3-45c2-aac2-36fce43062d06
311666metoclopramide (as metoclopramide HCl) 10 MG Oral TabletSYce367a41-89d3-45c2-aac2-36fce43062d06
311668metoclopramide 5 MG (as metoclopramide hydrochloride) Oral TabletSYce367a41-89d3-45c2-aac2-36fce43062d06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-235-126318702351212 TABLET in 1 BOTTLE (63187-235-12) 12 tablet2023-01-20NoNoCurrent
63187-235-306318702353030 TABLET in 1 BOTTLE (63187-235-30) 30 tablet2014-11-010000-00-00NoNoCurrent
63187-235-606318702356060 TABLET in 1 BOTTLE (63187-235-60) 60 tablet2014-11-010000-00-00NoNoCurrent
63187-235-906318702359090 TABLET in 1 BOTTLE (63187-235-90) 90 tablet2014-11-010000-00-00NoNoCurrent