Metoclopramide

Product NDC: 67296-2309
11-digit product format: 672962309
Labeler code: 67296
Product ID: 67296-2309_58e709e4-ce43-06ab-e063-6294a90a04ea
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Metoclopramide
Dosage form: TABLET
Route: ORAL
Labeler: Redpharm Drug
Application: ANDA078807
Marketing category: ANDA
Marketing start: 2025-01-09
Substance: METOCLOPRAMIDE HYDROCHLORIDE
Active strength: 10 mg/1
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 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A078807-001	METOCLOPRAMIDE HYDROCHLORIDE	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB		2008-06-12
A078807-002	METOCLOPRAMIDE HYDROCHLORIDE	METOCLOPRAMIDE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB		2008-06-12

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A078807-001	AB
A078807-002	AB

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.

Product history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A078807-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2008-06-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078807-002	METOCLOPRAMIDE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2008-06-12	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078807-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2008-06-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078807-002	METOCLOPRAMIDE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2008-06-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078807-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2008-06-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078807-002	METOCLOPRAMIDE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2008-06-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078807-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2008-06-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078807-002	METOCLOPRAMIDE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2008-06-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078807-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2008-06-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078807-002	METOCLOPRAMIDE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2008-06-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078807-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2008-06-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078807-002	METOCLOPRAMIDE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2008-06-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078807-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2008-06-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078807-002	METOCLOPRAMIDE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2008-06-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078807-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2008-06-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078807-002	METOCLOPRAMIDE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2008-06-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078807-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2008-06-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078807-002	METOCLOPRAMIDE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2008-06-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078807-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2008-06-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078807-002	METOCLOPRAMIDE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2008-06-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078807-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2008-06-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078807-002	METOCLOPRAMIDE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2008-06-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078807-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2008-06-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078807-002	METOCLOPRAMIDE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2008-06-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078807-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2008-06-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078807-002	METOCLOPRAMIDE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2008-06-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078807-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2008-06-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078807-002	METOCLOPRAMIDE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2008-06-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078807-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2008-06-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078807-002	METOCLOPRAMIDE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2008-06-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078807-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2008-06-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078807-002	METOCLOPRAMIDE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2008-06-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078807-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2008-06-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078807-002	METOCLOPRAMIDE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2008-06-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078807-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2008-06-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078807-002	METOCLOPRAMIDE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2008-06-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078807-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2008-06-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078807-002	METOCLOPRAMIDE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2008-06-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078807-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2008-06-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078807-002	METOCLOPRAMIDE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2008-06-12	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A078807-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078807-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078807-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078807-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078807-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078807-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078807-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078807-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078807-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078807-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078807-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078807-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078807-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078807-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078807-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078807-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078807-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078807-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078807-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078807-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078807-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078807-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078807-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078807-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078807-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078807-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078807-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078807-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078807-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078807-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078807-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078807-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078807-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078807-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078807-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078807-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078807-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078807-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078807-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078807-002	AB	1	`74a2ff9319b5…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Metoclopramide
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
METOCLOPRAMIDE HYDROCHLORIDE	10 mg/1

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
311666	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
58e70a1b-ac93-ff1d-e063-6394a90aa2da	Available on FDA.report

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metoclopramide	METOCLOPRAMIDE	Redpharm Drug	58e70a1b-ac93-ff1d-e063-6394a90aa2da	2026-08-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078807 application number: ANDA078807 ndc (product): 67296-2309
Metoclopramide	METOCLOPRAMIDE	NuCare Pharmaceuticals,Inc.	58b3666f-ac0f-811e-e063-6394a90a8e04	2026-08-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078807 application number: ANDA078807
Metoclopramide	METOCLOPRAMIDE	Ipca Laboratories Limited	c143e210-4ce7-44e5-b1e2-bf0e6bfde485	2026-07-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078807 application number: ANDA078807
Metoclopramide	METOCLOPRAMIDE	NuCare Pharmaceuticals, Inc.	548e83bc-898f-6b16-e063-6294a90a1755	2026-06-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078807 application number: ANDA078807

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
W1792A2RVD	METOCLOPRAMIDE HYDROCHLORIDE	54143-57-6	METOCLOPRAMIDE HYDROCHLORIDE
L4YEB44I46	METOCLOPRAMIDE	364-62-5	Metoclopramide

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
67296-2309-2	67296230902	15 TABLET in 1 BOTTLE (67296-2309-2)	15 tablet	2025-01-09	No	No	Current