GIMOTI

Product NDC
72089-307
Requested package NDC
72089-307-15
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N209388-001GIMOTIMETOCLOPRAMIDE HYDROCHLORIDEEQ 15MG BASE/SPRAYSPRAY, METERED / NASALRLD, RS2020-06-19

Orange Book patents#

Current patent rows page 1 of 1 · 7 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N209388-001110203612029-12-22U-28432021-06-03
N209388-001116281502029-12-22U-2843Drug product2023-04-25
N209388-001118132312029-12-22U-2843Drug product2023-11-16
N209388-001121940082029-12-22U-28432025-01-27
N209388-001121940092029-12-22U-28432025-01-27
N209388-00183342812030-05-16U-2843Drug product2020-06-29
N209388-001123770642038-11-17U-28432025-08-05

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N209388-001GIMOTIEQ 15MG BASE/SPRAYSPRAY, METERED / NASALRLD, RS2020-06-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209388-001GIMOTIEQ 15MG BASE/SPRAYSPRAY, METERED / NASALRLD, RS2020-06-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08N209388-001GIMOTIEQ 15MG BASE/SPRAYSPRAY, METERED / NASALRLD, RS2020-06-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209388-001GIMOTIEQ 15MG BASE/SPRAYSPRAY, METERED / NASALRLD, RS2020-06-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N209388-001GIMOTIEQ 15MG BASE/SPRAYSPRAY, METERED / NASALRLD, RS2020-06-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N209388-001GIMOTIEQ 15MG BASE/SPRAYSPRAY, METERED / NASALRLD, RS2020-06-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N209388-001GIMOTIEQ 15MG BASE/SPRAYSPRAY, METERED / NASALRLD, RS2020-06-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N209388-001GIMOTIEQ 15MG BASE/SPRAYSPRAY, METERED / NASALRLD, RS2020-06-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N209388-001GIMOTIEQ 15MG BASE/SPRAYSPRAY, METERED / NASALRLD, RS2020-06-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N209388-001GIMOTIEQ 15MG BASE/SPRAYSPRAY, METERED / NASALRLD, RS2020-06-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N209388-001GIMOTIEQ 15MG BASE/SPRAYSPRAY, METERED / NASALRLD, RS2020-06-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N209388-001GIMOTIEQ 15MG BASE/SPRAYSPRAY, METERED / NASALRLD, RS2020-06-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N209388-001GIMOTIEQ 15MG BASE/SPRAYSPRAY, METERED / NASALRLD, RS2020-06-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05N209388-001GIMOTIEQ 15MG BASE/SPRAYSPRAY, METERED / NASALRLD, RS2020-06-198072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N209388-001GIMOTIEQ 15MG BASE/SPRAYSPRAY, METERED / NASALRLD, RS2020-06-195c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N209388-001GIMOTIEQ 15MG BASE/SPRAYSPRAY, METERED / NASALRLD, RS2020-06-195d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N209388-001GIMOTIEQ 15MG BASE/SPRAYSPRAY, METERED / NASALRLD, RS2020-06-194b0b4de00fa7…
2022-03-09 01:35 UTC2022-03N209388-001GIMOTIEQ 15MG BASE/SPRAYSPRAY, METERED / NASALRLD, RS2020-06-19bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N209388-001GIMOTIEQ 15MG BASE/SPRAYSPRAY, METERED / NASALRLD, RS2020-06-19782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N209388-001GIMOTIEQ 15MG BASE/SPRAYSPRAY, METERED / NASALRLD, RS2020-06-1987673890dc5c…
2021-03-12 10:30 UTC2021-03N209388-001GIMOTIEQ 15MG BASE/SPRAYSPRAY, METERED / NASALRLD, RS2020-06-195aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N209388-001GIMOTIEQ 15MG BASE/SPRAYSPRAY, METERED / NASALRLD, RS2020-06-198869cabd3fbd…
2020-11-12 02:37 UTC2020-11N209388-001GIMOTIEQ 15MG BASE/SPRAYSPRAY, METERED / NASALRLD, RS2020-06-19c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N209388-001GIMOTIEQ 15MG BASE/SPRAYSPRAY, METERED / NASALRLD, RS2020-06-196a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N209388-001GIMOTIEQ 15MG BASE/SPRAYSPRAY, METERED / NASALRLD, RS2020-06-191c564ffb4f44…
2023-12-20 04:57 UTC2023-12N209388-001GIMOTIEQ 15MG BASE/SPRAYSPRAY, METERED / NASALRLD, RS2020-06-19ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N209388-001GIMOTIEQ 15MG BASE/SPRAYSPRAY, METERED / NASALRLD, RS2020-06-19a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N209388-001GIMOTIEQ 15MG BASE/SPRAYSPRAY, METERED / NASALRLD, RS2020-06-199b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N209388-001GIMOTIEQ 15MG BASE/SPRAYSPRAY, METERED / NASALRLD, RS2020-06-19a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N209388-001GIMOTIEQ 15MG BASE/SPRAYSPRAY, METERED / NASALRLD, RS2020-06-193f0d92c62455…
2023-05-13 08:27 UTC2023-05N209388-001GIMOTIEQ 15MG BASE/SPRAYSPRAY, METERED / NASALRLD, RS2020-06-19053a50430f4f…
2023-01-26 05:58 UTC2023-01N209388-001GIMOTIEQ 15MG BASE/SPRAYSPRAY, METERED / NASALRLD, RS2020-06-193bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N209388-001GIMOTIEQ 15MG BASE/SPRAYSPRAY, METERED / NASALRLD, RS2020-06-193a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N209388-001GIMOTIEQ 15MG BASE/SPRAYSPRAY, METERED / NASALRLD, RS2020-06-19f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N209388-001GIMOTIEQ 15MG BASE/SPRAYSPRAY, METERED / NASALRLD, RS2020-06-19e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N209388-001GIMOTIEQ 15MG BASE/SPRAYSPRAY, METERED / NASALRLD, RS2020-06-19cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N209388-001GIMOTIEQ 15MG BASE/SPRAYSPRAY, METERED / NASALRLD, RS2020-06-19a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 4 · 131 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N209388-001110203612029-12-22U-28432021-06-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209388-001116281502029-12-22U-2843Drug product2023-04-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209388-001118132312029-12-22U-2843Drug product2023-11-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209388-001121940082029-12-22U-28432025-01-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209388-001121940092029-12-22U-28432025-01-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209388-00183342812030-05-16U-2843Drug product2020-06-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209388-001123770642038-11-17U-28432025-08-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209388-001110203612029-12-22U-28432021-06-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209388-001116281502029-12-22U-2843Drug product2023-04-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209388-001118132312029-12-22U-2843Drug product2023-11-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209388-001121940082029-12-22U-28432025-01-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209388-001121940092029-12-22U-28432025-01-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209388-00183342812030-05-16U-2843Drug product2020-06-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209388-001123770642038-11-17U-28432025-08-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08N209388-001110203612029-12-22U-28432021-06-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209388-001116281502029-12-22U-2843Drug product2023-04-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209388-001118132312029-12-22U-2843Drug product2023-11-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209388-001121940082029-12-22U-28432025-01-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209388-001121940092029-12-22U-28432025-01-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209388-00183342812030-05-16U-2843Drug product2020-06-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209388-001123770642038-11-17U-28432025-08-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209388-001110203612029-12-22U-28432021-06-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209388-001116281502029-12-22U-2843Drug product2023-04-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209388-001118132312029-12-22U-2843Drug product2023-11-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209388-001121940082029-12-22U-28432025-01-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209388-001121940092029-12-22U-28432025-01-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209388-00183342812030-05-16U-2843Drug product2020-06-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N209388-001110203612029-12-22U-28432021-06-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N209388-001116281502029-12-22U-2843Drug product2023-04-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N209388-001118132312029-12-22U-2843Drug product2023-11-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N209388-001121940082029-12-22U-28432025-01-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N209388-001121940092029-12-22U-28432025-01-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N209388-00183342812030-05-16U-2843Drug product2020-06-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N209388-001110203612029-12-22U-28432021-06-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N209388-001116281502029-12-22U-2843Drug product2023-04-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N209388-001118132312029-12-22U-2843Drug product2023-11-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N209388-00183342812030-05-16U-2843Drug product2020-06-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N209388-001110203612029-12-22U-28432021-06-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N209388-001116281502029-12-22U-2843Drug product2023-04-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N209388-001118132312029-12-22U-2843Drug product2023-11-162680178bc6a6…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N209388-001NP2023-06-195c6f7cd8ea54…
2023-12-20 04:57 UTC2023-12N209388-001NP2023-06-19ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N209388-001NP2023-06-19a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N209388-001NP2023-06-199b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N209388-001NP2023-06-19a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N209388-001NP2023-06-193f0d92c62455…
2023-05-13 08:27 UTC2023-05N209388-001NP2023-06-19053a50430f4f…
2023-01-26 05:58 UTC2023-01N209388-001NP2023-06-193bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N209388-001NP2023-06-193a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N209388-001NP2023-06-19f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N209388-001NP2023-06-19e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N209388-001NP2023-06-19cb3db0bc1861…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GIMOTIMETOCLOPRAMIDE HYDROCHLORIDEEvoke Pharma, Inc.95269b1f-779c-4ca0-9f86-e74e677f99002026-02-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 209388
application number: NDA209388
ndc (package): 72089-307-15
ndc (product): 72089-307
ndc11 (package): 72089030715

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
W1792A2RVDInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2380564Internal RxNorm lookup
2380570Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
95269b1f-779c-4ca0-9f86-e74e677f9900Available on FDA.report

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