METOCLOPRAMIDE

Product NDC: 51662-1367
11-digit product format: 516621367
Labeler code: 51662
Product ID: 51662-1367_ef7bd5a0-02a8-7b66-e053-2995a90a8ffa
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: METOCLOPRAMIDE
Dosage form: INJECTION, SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: HF Acquisition Co LLC, DBA HealthFirst
Application: ANDA091392
Marketing category: ANDA
Marketing start: 2019-10-14
Substance: METOCLOPRAMIDE HYDROCHLORIDE
Active strength: 10 mg/2mL
Pharmacologic classes: Dopamine D2 Antagonists [MoA], Dopamine-2 Receptor Antagonist [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
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
A091392-001	METOCLOPRAMIDE HYDROCHLORIDE	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP		2013-04-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091392-001	AP

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 2 · 41 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
2026-02-19 14:30 UTC	2026-02	A091392-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION		2013-04-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091392-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION		2013-04-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091392-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION		2013-04-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091392-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2013-04-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091392-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2013-04-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091392-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2013-04-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091392-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2013-04-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091392-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2013-04-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091392-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2013-04-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091392-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2013-04-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091392-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2013-04-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091392-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2013-04-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091392-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2013-04-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091392-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2013-04-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091392-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2013-04-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091392-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2013-04-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091392-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2013-04-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091392-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2013-04-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091392-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2013-04-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091392-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2013-04-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091392-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2013-04-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091392-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2013-04-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091392-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2013-04-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091392-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2013-04-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091392-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2013-04-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091392-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2013-04-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091392-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2013-04-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091392-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2013-04-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091392-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2013-04-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091392-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2013-04-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091392-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2013-04-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091392-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2013-04-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091392-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2013-04-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091392-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2013-04-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091392-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2013-04-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091392-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2013-04-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091392-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2013-04-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091392-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2013-04-19	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091392-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2013-04-19	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091392-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2013-04-19	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091392-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091392-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091392-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091392-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091392-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091392-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091392-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091392-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091392-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091392-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091392-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091392-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091392-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091392-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091392-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091392-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091392-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091392-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091392-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091392-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091392-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091392-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091392-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091392-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091392-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091392-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091392-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091392-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091392-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091392-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091392-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091392-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091392-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091392-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091392-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091392-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091392-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A091392-001	AP	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: METOCLOPRAMIDE
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
METOCLOPRAMIDE HYDROCHLORIDE	10 mg/2mL

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
727619	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
94e5acdf-f19c-749a-e053-2995a90ae451	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
86441fd8-22b8-41db-bb26-c70dffc3923b	Product name	1	20210111
340a6817-217a-4b71-9e83-8e2e60c4b0c5	Product name	1	20150319
1f2c49ec-0a44-8021-ecde-b27ece080b13	Product name	1	20140508
46471181-3fa6-5fcd-1d9f-1bb9d2b06171	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
51662-1367-1	METOCLOPRAMIDE	1 in 1 BLISTER PACK	INJECTION, SOLUTION	1		3
51662-1367-1	METOCLOPRAMIDE	2 mL in 1 SYRINGE, GLASS	INJECTION, SOLUTION	2		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51662-1367	METOCLOPRAMIDE INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST]	3	Current NDC, Legacy NDC, 2 package rows	20221211_94e5acdf-f19c-749a-e053-2995a90ae451.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metoclopramide	METOCLOPRAMIDE HYDROCHLORIDE	Fresenius Kabi USA, LLC	cc739885-e10e-4bcb-a781-c726c518f3d1	2023-06-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091392 application number: ANDA091392
METOCLOPRAMIDE	METOCLOPRAMIDE	HF Acquisition Co LLC, DBA HealthFirst	94e5acdf-f19c-749a-e053-2995a90ae451	2022-12-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091392 application number: ANDA091392 ndc (product): 51662-1367

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
727619	metoclopramide 10 MG in 2 ML Prefilled Syringe	PSN	94e5acdf-f19c-749a-e053-2995a90ae451	3
727619	2 ML metoclopramide 5 MG/ML Prefilled Syringe	SCD	94e5acdf-f19c-749a-e053-2995a90ae451	3
727619	metoclopramide (as the monohydrochloride monohydrate) 10 MG per 2 ML Prefilled Syringe	SY	94e5acdf-f19c-749a-e053-2995a90ae451	3
727619	metoclopramide 10 MG per 2 ML Prefilled Syringe	SY	94e5acdf-f19c-749a-e053-2995a90ae451	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
51662-1367-1	51662136701	1 SYRINGE, GLASS in 1 BLISTER PACK (51662-1367-1) / 2 mL in 1 SYRINGE, GLASS	2019-10-14	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
METOCLOPRAMIDE INJECTION, USP 10 mg/2 Ml (5mg/mL) 2mL SYR	HF Acquisition Co LLC, DBA HealthFirst	2022-12-10	HUMAN PRESCRIPTION DRUG LABEL	3