GIMOTI

Product NDC
72089-307
11-digit product format
720890307
Labeler code
72089
Product ID
72089-307_4b47dd3d-4a37-e136-e063-6394a90a31ef
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
METOCLOPRAMIDE HYDROCHLORIDE
Dosage form
SPRAY
Route
NASAL
Labeler
Evoke Pharma, Inc.
Application
NDA209388
Marketing category
NDA
Marketing start
2020-06-19
Substance
METOCLOPRAMIDE HYDROCHLORIDE
Active strength
15 mg/.07mL
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
GIMOTI
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METOCLOPRAMIDE HYDROCHLORIDE15 mg/.07mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiW1792A2RVD
Rxcui2380564, 2380570

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
72089-307-15GIMOTI1 in 1 CARTONSPRAY16
72089-307-15GIMOTI9.8 mL in 1 BOTTLE, PUMPSPRAY9.86

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72089-307GIMOTI (METOCLOPRAMIDE HYDROCHLORIDE) SPRAY [EVOKE PHARMA, INC.]2Current NDC, Legacy NDC, 2 package rows20210109_95269b1f-779c-4ca0-9f86-e74e677f9900.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2380570Gimoti 15 MG/ACTUAT Nasal SprayPSN95269b1f-779c-4ca0-9f86-e74e677f99006
2380564metoclopramide 15 MG/ACTUAT Nasal SprayPSN95269b1f-779c-4ca0-9f86-e74e677f99006
2380570metoclopramide 15 MG/ACTUAT Nasal Spray [Gimoti]SBD95269b1f-779c-4ca0-9f86-e74e677f99006
2380564metoclopramide 15 MG/ACTUAT Nasal SpraySCD95269b1f-779c-4ca0-9f86-e74e677f99006
2380570Gimoti 15 MG/ACTUAT (equivalent to 17.73 MG/ACTUAT of metoclopramide HCl) Nasal SpraySY95269b1f-779c-4ca0-9f86-e74e677f99006
2380570Gimoti 15 MG/ACTUAT Nasal SpraySY95269b1f-779c-4ca0-9f86-e74e677f99006
2380564metoclopramide 15 MG/ACTUAT (equivalent to 17.73 MG/ACTUAT of metoclopramide HCl) Nasal SpraySY95269b1f-779c-4ca0-9f86-e74e677f99006

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72089-307-15720890307151 BOTTLE, PUMP in 1 CARTON (72089-307-15) / 9.8 mL in 1 BOTTLE, PUMP2020-06-190000-00-00NoNoCurrent