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# 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.
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
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