FDA.reportPublic FDA data

metoclopramide hydrochloride

Product NDC
62135-526
11-digit product format
621350526
Labeler code
62135
Product ID
62135-526_49dc78f2-e942-afb5-e063-6394a90a20d5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
metoclopramide hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Chartwell RX, LLC
Application
ANDA073680
Marketing category
ANDA
Marketing start
1992-10-27
Substance
METOCLOPRAMIDE HYDROCHLORIDE
Active strength
5 mg/5mL
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 hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METOCLOPRAMIDE HYDROCHLORIDE5 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiW1792A2RVD
Rxcui104884

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
62135-526-10metoclopramide hydrochloride10 mL in 1 CUPSOLUTION103
62135-526-24metoclopramide hydrochloride2 in 1 BOXSOLUTION23
62135-526-24metoclopramide hydrochloride10 in 1 TRAYSOLUTION103
62135-526-47metoclopramide hydrochloride473 mL in 1 BOTTLESOLUTION4733

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-526-10ML - Milliliter62135-5266d141b8e-77e3-46d0-bff6-2973033b842312024-12-10
62135-526-24ML - Milliliter62135-5261c73cc17-7de7-45cb-b2be-77bf19f4ca0a12024-12-10
62135-526-47ML - Milliliter62135-52643bc1ce9-607f-4a0c-88e3-a7cbc33889ee12023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-526METOCLOPRAMIDE HYDROCHLORIDE SOLUTION [CHARTWELL RX, LLC]2Current NDC, 4 package rows20241024_dc364325-dd39-4259-a348-3760eccdca4b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
104884metoclopramide 5 MG in 5 mL Oral SolutionPSNdc364325-dd39-4259-a348-3760eccdca4b3
104884metoclopramide 1 MG/ML Oral SolutionSCDdc364325-dd39-4259-a348-3760eccdca4b3
104884metoclopramide (as the monohydrochloride monohydrate) 5 MG per 5 ML Oral SolutionSYdc364325-dd39-4259-a348-3760eccdca4b3
104884metoclopramide 5 MG per 5 ML Oral SolutionSYdc364325-dd39-4259-a348-3760eccdca4b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62135-526-106213505261010 mL in 1 CUP10 mlHistorical
62135-526-24621350526242 TRAY in 1 BOX (62135-526-24) / 10 CUP in 1 TRAY / 10 mL in 1 CUP (62135-526-10) 2 tray2024-10-14NoNoCurrent
62135-526-4762135052647473 mL in 1 BOTTLE (62135-526-47) 473 ml2023-03-21NoNoCurrent