FDA.reportPublic FDA data

Metoclopramide

Product NDC
66267-827
11-digit product format
662670827
Labeler code
66267
Product ID
66267-827_1fa77075-a19a-971d-e063-6294a90a255d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoclopramide
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
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

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
66267-827-042024-08-14C16284748780-1f386c64a-1466-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use METOCLOPRAMIDE TABLETS safely and effectively. See full prescribing information for METOCLOPRAMIDE TABLETS. METOCLOPRAMIDE tablets, for oral use Initial U.S. Approval: 1979
66267-827-062024-08-14C16284748780-1f386c64a-1466-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use METOCLOPRAMIDE TABLETS safely and effectively. See full prescribing information for METOCLOPRAMIDE TABLETS. METOCLOPRAMIDE tablets, for oral use Initial U.S. Approval: 1979
66267-827-082024-08-14C16284748780-1f386c64a-1466-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use METOCLOPRAMIDE TABLETS safely and effectively. See full prescribing information for METOCLOPRAMIDE TABLETS. METOCLOPRAMIDE tablets, for oral use Initial U.S. Approval: 1979
66267-827-042023-01-30C16284748780-1f386c64a-1466-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use METOCLOPRAMIDE TABLETS safely and effectively. See full prescribing information for METOCLOPRAMIDE TABLETS. METOCLOPRAMIDE tablets, for oral use Initial U.S. Approval: 1979
66267-827-062023-01-30C16284748780-1f386c64a-1466-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use METOCLOPRAMIDE TABLETS safely and effectively. See full prescribing information for METOCLOPRAMIDE TABLETS. METOCLOPRAMIDE tablets, for oral use Initial U.S. Approval: 1979
66267-827-082023-01-30C16284748780-1f386c64a-1466-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use METOCLOPRAMIDE TABLETS safely and effectively. See full prescribing information for METOCLOPRAMIDE TABLETS. METOCLOPRAMIDE tablets, for oral use Initial U.S. Approval: 1979

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66267-827-04Metoclopramide4 in 1 BOTTLETABLET44
66267-827-06Metoclopramide6 in 1 BOTTLETABLET64
66267-827-08Metoclopramide8 in 1 BOTTLETABLET84

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66267-827METOCLOPRAMIDE TABLET [NUCARE PHARMACEUTICALS,INC.]4Current NDC, Legacy NDC, 3 package rows20240815_5d7cd5a0-4a84-4084-e053-2a91aa0a686f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311666metoclopramide HCl 10 MG Oral TabletPSN5d7cd5a0-4a84-4084-e053-2a91aa0a686f4
311666metoclopramide 10 MG Oral TabletSCD5d7cd5a0-4a84-4084-e053-2a91aa0a686f4
311666metoclopramide (as metoclopramide HCl) 10 MG Oral TabletSY5d7cd5a0-4a84-4084-e053-2a91aa0a686f4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66267-827-04662670827044 TABLET in 1 BOTTLE (66267-827-04) 4 tablet2017-11-080000-00-00NoNoCurrent
66267-827-06662670827066 TABLET in 1 BOTTLE (66267-827-06) 6 tablet2017-11-080000-00-00NoNoCurrent
66267-827-08662670827088 TABLET in 1 BOTTLE (66267-827-08) 8 tablet2017-11-080000-00-00NoNoCurrent