Home NDC 72089-307-15 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N209388-001 GIMOTI METOCLOPRAMIDE HYDROCHLORIDE EQ 15MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 2020-06-19
Orange Book patents# Current patent rows page 1 of 1 · 7 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N209388-001 11020361 2029-12-22 U-2843 2021-06-03 N209388-001 11628150 2029-12-22 U-2843 Drug product 2023-04-25 N209388-001 11813231 2029-12-22 U-2843 Drug product 2023-11-16 N209388-001 12194008 2029-12-22 U-2843 2025-01-27 N209388-001 12194009 2029-12-22 U-2843 2025-01-27 N209388-001 8334281 2030-05-16 U-2843 Drug product 2020-06-29 N209388-001 12377064 2038-11-17 U-2843 2025-08-05
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N209388-001 GIMOTI EQ 15MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 2020-06-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209388-001 GIMOTI EQ 15MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 2020-06-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N209388-001 GIMOTI EQ 15MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 2020-06-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209388-001 GIMOTI EQ 15MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 2020-06-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209388-001 GIMOTI EQ 15MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 2020-06-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209388-001 GIMOTI EQ 15MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 2020-06-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209388-001 GIMOTI EQ 15MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 2020-06-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209388-001 GIMOTI EQ 15MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 2020-06-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N209388-001 GIMOTI EQ 15MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 2020-06-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N209388-001 GIMOTI EQ 15MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 2020-06-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N209388-001 GIMOTI EQ 15MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 2020-06-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N209388-001 GIMOTI EQ 15MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 2020-06-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N209388-001 GIMOTI EQ 15MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 2020-06-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N209388-001 GIMOTI EQ 15MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 2020-06-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N209388-001 GIMOTI EQ 15MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 2020-06-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N209388-001 GIMOTI EQ 15MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 2020-06-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N209388-001 GIMOTI EQ 15MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 2020-06-19 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N209388-001 GIMOTI EQ 15MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 2020-06-19 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N209388-001 GIMOTI EQ 15MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 2020-06-19 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N209388-001 GIMOTI EQ 15MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 2020-06-19 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N209388-001 GIMOTI EQ 15MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 2020-06-19 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N209388-001 GIMOTI EQ 15MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 2020-06-19 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N209388-001 GIMOTI EQ 15MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 2020-06-19 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N209388-001 GIMOTI EQ 15MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 2020-06-19 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N209388-001 GIMOTI EQ 15MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 2020-06-19 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N209388-001 GIMOTI EQ 15MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 2020-06-19 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N209388-001 GIMOTI EQ 15MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 2020-06-19 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N209388-001 GIMOTI EQ 15MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 2020-06-19 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N209388-001 GIMOTI EQ 15MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 2020-06-19 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N209388-001 GIMOTI EQ 15MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 2020-06-19 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N209388-001 GIMOTI EQ 15MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 2020-06-19 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N209388-001 GIMOTI EQ 15MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 2020-06-19 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N209388-001 GIMOTI EQ 15MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 2020-06-19 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N209388-001 GIMOTI EQ 15MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 2020-06-19 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N209388-001 GIMOTI EQ 15MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 2020-06-19 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N209388-001 GIMOTI EQ 15MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 2020-06-19 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N209388-001 GIMOTI EQ 15MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 2020-06-19 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 4 · 131 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N209388-001 11020361 2029-12-22 U-2843 2021-06-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209388-001 11628150 2029-12-22 U-2843 Drug product 2023-04-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209388-001 11813231 2029-12-22 U-2843 Drug product 2023-11-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209388-001 12194008 2029-12-22 U-2843 2025-01-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209388-001 12194009 2029-12-22 U-2843 2025-01-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209388-001 8334281 2030-05-16 U-2843 Drug product 2020-06-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209388-001 12377064 2038-11-17 U-2843 2025-08-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209388-001 11020361 2029-12-22 U-2843 2021-06-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209388-001 11628150 2029-12-22 U-2843 Drug product 2023-04-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209388-001 11813231 2029-12-22 U-2843 Drug product 2023-11-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209388-001 12194008 2029-12-22 U-2843 2025-01-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209388-001 12194009 2029-12-22 U-2843 2025-01-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209388-001 8334281 2030-05-16 U-2843 Drug product 2020-06-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209388-001 12377064 2038-11-17 U-2843 2025-08-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N209388-001 11020361 2029-12-22 U-2843 2021-06-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209388-001 11628150 2029-12-22 U-2843 Drug product 2023-04-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209388-001 11813231 2029-12-22 U-2843 Drug product 2023-11-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209388-001 12194008 2029-12-22 U-2843 2025-01-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209388-001 12194009 2029-12-22 U-2843 2025-01-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209388-001 8334281 2030-05-16 U-2843 Drug product 2020-06-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209388-001 12377064 2038-11-17 U-2843 2025-08-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209388-001 11020361 2029-12-22 U-2843 2021-06-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209388-001 11628150 2029-12-22 U-2843 Drug product 2023-04-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209388-001 11813231 2029-12-22 U-2843 Drug product 2023-11-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209388-001 12194008 2029-12-22 U-2843 2025-01-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209388-001 12194009 2029-12-22 U-2843 2025-01-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209388-001 8334281 2030-05-16 U-2843 Drug product 2020-06-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209388-001 11020361 2029-12-22 U-2843 2021-06-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209388-001 11628150 2029-12-22 U-2843 Drug product 2023-04-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209388-001 11813231 2029-12-22 U-2843 Drug product 2023-11-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209388-001 12194008 2029-12-22 U-2843 2025-01-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209388-001 12194009 2029-12-22 U-2843 2025-01-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209388-001 8334281 2030-05-16 U-2843 Drug product 2020-06-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209388-001 11020361 2029-12-22 U-2843 2021-06-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209388-001 11628150 2029-12-22 U-2843 Drug product 2023-04-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209388-001 11813231 2029-12-22 U-2843 Drug product 2023-11-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209388-001 8334281 2030-05-16 U-2843 Drug product 2020-06-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209388-001 11020361 2029-12-22 U-2843 2021-06-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209388-001 11628150 2029-12-22 U-2843 Drug product 2023-04-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209388-001 11813231 2029-12-22 U-2843 Drug product 2023-11-16 2680178bc6a6…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base GIMOTI
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength METOCLOPRAMIDE HYDROCHLORIDE 15 mg/.07mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination W1792A2RVD Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2380564 Internal RxNorm lookup 2380570 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 72089-307-15 GIMOTI 1 in 1 CARTON SPRAY 1 6 72089-307-15 GIMOTI 9.8 mL in 1 BOTTLE, PUMP SPRAY 9.8 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72089-307 GIMOTI (METOCLOPRAMIDE HYDROCHLORIDE) SPRAY [EVOKE PHARMA, INC.] 2 Current NDC, Legacy NDC, 2 package rows 20210109_95269b1f-779c-4ca0-9f86-e74e677f9900.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 72089-307-15 72089030715 1 BOTTLE, PUMP in 1 CARTON (72089-307-15) / 9.8 mL in 1 BOTTLE, PUMP 2020-06-19 0000-00-00 No No Current