FDA.reportPublic FDA data

Metoclopramide

Product NDC
33261-166
11-digit product format
332610166
Labeler code
33261
Product ID
33261-166_9f5ed975-8bb7-4b71-af13-292cbd830a24
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoclopramide
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA070184
Marketing category
ANDA
Marketing start
1990-09-30
Marketing end
0000-00-00
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
2019-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
33261-166-302020-01-31C16284748780-19d75b9d0-cce8-f424-e053-dadaa90a57ceMETOCLOPRAMIDE TABLETS, USP 2204 2203
33261-166-602020-01-31C16284748780-19d75b9d0-cce8-f424-e053-dadaa90a57ceMETOCLOPRAMIDE TABLETS, USP 2204 2203

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-166-30Metoclopramide30 in 1 BOTTLE, PLASTICTABLET301
33261-166-60Metoclopramide60 in 1 BOTTLE, PLASTICTABLET601

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-166METOCLOPRAMIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 2 package rows20140128_13f5c0a5-a763-42d3-a33f-a3b32d8769e0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311666metoclopramide HCl 10 MG Oral TabletPSN13f5c0a5-a763-42d3-a33f-a3b32d8769e01
311666metoclopramide 10 MG Oral TabletSCD13f5c0a5-a763-42d3-a33f-a3b32d8769e01
311666metoclopramide (as metoclopramide HCl) 10 MG Oral TabletSY13f5c0a5-a763-42d3-a33f-a3b32d8769e01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-166-303326101663030 in 1 BOTTLE, PLASTICHistorical
33261-166-603326101666060 in 1 BOTTLE, PLASTICHistorical