FDA.reportPublic FDA data

Metoclopramide

Product NDC
60687-631
11-digit product format
606870631
Labeler code
60687
Product ID
60687-631_223f574d-b64f-236d-e063-6294a90aada1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoclopramide
Dosage form
TABLET
Route
ORAL
Labeler
American Health Packaging
Application
ANDA070184
Marketing category
ANDA
Marketing start
2022-01-24
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
60687-631-01Metoclopramide100 in 1 BOX, UNIT-DOSETABLET1003
60687-631-11Metoclopramide1 in 1 BLISTER PACKTABLET13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-631-01EA - Each60687-63163bc86ae-c05d-4c31-b52b-c369a62b804912022-02-07
60687-631-11EA - Each60687-6310723c6dc-a447-4b88-9582-44efbc705a8d12022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-631METOCLOPRAMIDE TABLET [AMERICAN HEALTH PACKAGING]3Current NDC, Legacy NDC, 2 package rows20240918_998f1782-bbfa-469b-9fe1-c612e8588f70.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311666metoclopramide HCl 10 MG Oral TabletPSN998f1782-bbfa-469b-9fe1-c612e8588f703
311668metoclopramide HCl 5 MG Oral TabletPSN998f1782-bbfa-469b-9fe1-c612e8588f703
311666metoclopramide 10 MG Oral TabletSCD998f1782-bbfa-469b-9fe1-c612e8588f703
311668metoclopramide 5 MG Oral TabletSCD998f1782-bbfa-469b-9fe1-c612e8588f703
311666metoclopramide (as metoclopramide HCl) 10 MG Oral TabletSY998f1782-bbfa-469b-9fe1-c612e8588f703
311668metoclopramide 5 MG (as metoclopramide hydrochloride) Oral TabletSY998f1782-bbfa-469b-9fe1-c612e8588f703

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-631-0160687063101100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-631-01) / 1 TABLET in 1 BLISTER PACK (60687-631-11) 100 blister pack2022-01-240000-00-00NoNoCurrent
60687-631-11606870631111 in 1 BLISTER PACKHistorical