FDA.reportPublic FDA data

METOCLOPRAMIDE hydrochloride

Product NDC
43386-580
11-digit product format
433860580
Labeler code
43386
Product ID
43386-580_b5844be2-94b3-3e3f-e053-2995a90a6eb8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoclopramide Hydrochloride
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Lupin Pharmaceuticals,Inc.
Application
ANDA202191
Marketing category
ANDA
Marketing start
2015-04-06
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 hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METOCLOPRAMIDE HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiW1792A2RVD
Rxcui608623, 608624

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
43386-580-31METOCLOPRAMIDE hydrochloride10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING103
43386-580-31METOCLOPRAMIDE hydrochloride1 in 1 CARTONTABLET, ORALLY DISINTEGRATING13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43386-580-30EA - Each43386-5802f31ff1b-ed6c-46fa-945d-eab743dfb30f12015-11-12
43386-580-31EA - Each43386-58083745f68-c052-459c-b350-66068af851b012017-09-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43386-580METOCLOPRAMIDE HYDROCHLORIDE TABLET, ORALLY DISINTEGRATING [LUPIN PHARMACEUTICALS,INC.]3Current NDC, Legacy NDC, 2 package rows20201203_7cd1dc35-2fb2-4f1d-8769-24c3c3aa34fa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
608623metoclopramide HCl 10 MG Disintegrating Oral TabletPSN7cd1dc35-2fb2-4f1d-8769-24c3c3aa34fa3
608624metoclopramide HCl 5 MG Disintegrating Oral TabletPSN7cd1dc35-2fb2-4f1d-8769-24c3c3aa34fa3
608623metoclopramide 10 MG Disintegrating Oral TabletSCD7cd1dc35-2fb2-4f1d-8769-24c3c3aa34fa3
608624metoclopramide 5 MG Disintegrating Oral TabletSCD7cd1dc35-2fb2-4f1d-8769-24c3c3aa34fa3
608623metoclopramide 10 MG (metoclopramide hydrochloride 11.82 MG) Disintegrating Oral TabletSY7cd1dc35-2fb2-4f1d-8769-24c3c3aa34fa3
608624metoclopramide 5 MG (as metoclopramide HCl 5.91 MG) Disintegrating Oral TabletSY7cd1dc35-2fb2-4f1d-8769-24c3c3aa34fa3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43386-580-31433860580311 BLISTER PACK in 1 CARTON (43386-580-31) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK1 blister pack2015-04-060000-00-00NoNoCurrent