FDA.reportPublic FDA data

Metoclopramide

Product NDC
42291-596
11-digit product format
422910596
Labeler code
42291
Product ID
42291-596_4870ff00-f729-814d-e063-6394a90a6c8e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoclopramide
Dosage form
TABLET
Route
ORAL
Labeler
AvKARE
Application
ANDA070184
Marketing category
ANDA
Marketing start
2014-10-01
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
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 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
42291-596-90Metoclopramide90 in 1 BOTTLETABLET909

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-596-90EA - Each42291-596c71ab6dc-364b-4535-8cd3-10982e5d628812014-11-05

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42291-596METOCLOPRAMIDE TABLET [AVKARE]8Current NDC, Legacy NDC, 1 package rows20240111_ff067ac5-6efc-3e86-e6d5-590b2779491c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311666metoclopramide HCl 10 MG Oral TabletPSNff067ac5-6efc-3e86-e6d5-590b2779491c9
311668metoclopramide HCl 5 MG Oral TabletPSNff067ac5-6efc-3e86-e6d5-590b2779491c9
311666metoclopramide 10 MG Oral TabletSCDff067ac5-6efc-3e86-e6d5-590b2779491c9
311668metoclopramide 5 MG Oral TabletSCDff067ac5-6efc-3e86-e6d5-590b2779491c9
311666metoclopramide (as metoclopramide HCl) 10 MG Oral TabletSYff067ac5-6efc-3e86-e6d5-590b2779491c9
311668metoclopramide 5 MG (as metoclopramide hydrochloride) Oral TabletSYff067ac5-6efc-3e86-e6d5-590b2779491c9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42291-596-904229105969090 TABLET in 1 BOTTLE (42291-596-90) 90 tablet2014-10-010000-00-00NoNoCurrent