Metoclopramide

Product NDC: 64950-344
11-digit product format: 649500344
Labeler code: 64950
Product ID: 64950-344_c3ef09b0-2ebe-43d3-abb3-35aaca75e1c8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Metoclopramide Hydrochloride
Dosage form: SOLUTION
Route: ORAL
Labeler: Genus Lifesciences Inc.
Application: ANDA072744
Marketing category: ANDA
Marketing start: 2024-06-01
Substance: METOCLOPRAMIDE HYDROCHLORIDE
Active strength: 5 mg/5mL
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
A072744-001	METOCLOPRAMIDE HYDROCHLORIDE	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	RS	1991-05-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A072744-001	AA

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A072744-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	RS	1991-05-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072744-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	RS	1991-05-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072744-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	RS	1991-05-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072744-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	RS	1991-05-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072744-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	RS	1991-05-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072744-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	RS	1991-05-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072744-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	RS	1991-05-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072744-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	RS	1991-05-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072744-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	RS	1991-05-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072744-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	RS	1991-05-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072744-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	RS	1991-05-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072744-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	RS	1991-05-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072744-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	RS	1991-05-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A072744-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	RS	1991-05-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072744-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA		1991-05-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A072744-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA		1991-05-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A072744-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA		1991-05-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A072744-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA		1991-05-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A072744-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA		1991-05-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A072744-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA		1991-05-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A072744-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA		1991-05-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A072744-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA		1991-05-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A072744-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA		1991-05-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A072744-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA		1991-05-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A072744-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA		1991-05-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A072744-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA		1991-05-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A072744-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA		1991-05-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A072744-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	RS	1991-05-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A072744-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	RS	1991-05-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A072744-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	RS	1991-05-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A072744-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	RS	1991-05-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A072744-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	RS	1991-05-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A072744-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA		1991-05-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A072744-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA		1991-05-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A072744-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA		1991-05-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A072744-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA		1991-05-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A072744-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA		1991-05-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A072744-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA		1991-05-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A072744-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA		1991-05-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A072744-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA		1991-05-28	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A072744-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072744-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072744-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072744-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072744-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072744-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072744-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072744-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072744-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072744-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072744-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072744-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072744-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A072744-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072744-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A072744-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A072744-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A072744-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A072744-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A072744-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A072744-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A072744-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A072744-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A072744-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A072744-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A072744-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A072744-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A072744-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A072744-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A072744-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A072744-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A072744-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A072744-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A072744-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A072744-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A072744-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A072744-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A072744-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A072744-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A072744-001	AA	1	`cb3db0bc1861…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
METOCLOPRAMIDE HYDROCHLORIDE	5 mg/5mL

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
104884	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
74358569-7a24-4a59-a7fc-500d2341d6cb	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
64950-344-16	Metoclopramide	473 mL in 1 BOTTLE, PLASTIC	SOLUTION	473		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
64950-344-16	ML - Milliliter	64950-344	e0476b07-e35b-4f7a-b7c4-56df7b185882	1	2024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64950-344	METOCLOPRAMIDE (METOCLOPRAMIDE HYDROCHLORIDE) SOLUTION [GENUS LIFESCIENCES INC.]	1	Current NDC, 1 package rows	20240601_74358569-7a24-4a59-a7fc-500d2341d6cb.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metoclopramide	METOCLOPRAMIDE HYDROCHLORIDE	ATLANTIC BIOLOGICALS CORP.	3cd4b274-6176-4e5b-9765-4f50763bd58f	2026-07-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072744 application number: ANDA072744
Metoclopramide	METOCLOPRAMIDE HYDROCHLORIDE	PAI Holdings, LLC dba PAI Pharma	3cc8ca5b-8b71-4c77-a181-9ce154597b9a	2024-11-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072744 application number: ANDA072744
Metoclopramide	METOCLOPRAMIDE HYDROCHLORIDE	Genus Lifesciences Inc.	74358569-7a24-4a59-a7fc-500d2341d6cb	2024-05-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072744 application number: ANDA072744 ndc (product): 64950-344

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
W1792A2RVD	METOCLOPRAMIDE HYDROCHLORIDE	54143-57-6	METOCLOPRAMIDE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
104884	metoclopramide 5 MG in 5 mL Oral Solution	PSN	74358569-7a24-4a59-a7fc-500d2341d6cb	1
104884	metoclopramide 1 MG/ML Oral Solution	SCD	74358569-7a24-4a59-a7fc-500d2341d6cb	1
104884	metoclopramide (as the monohydrochloride monohydrate) 5 MG per 5 ML Oral Solution	SY	74358569-7a24-4a59-a7fc-500d2341d6cb	1
104884	metoclopramide 5 MG per 5 ML Oral Solution	SY	74358569-7a24-4a59-a7fc-500d2341d6cb	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
64950-344-16	64950034416	473 mL in 1 BOTTLE, PLASTIC (64950-344-16)	473 ml	2024-06-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Metoclopramide	Genus Lifesciences Inc. \| PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma	2024-05-28	HUMAN PRESCRIPTION DRUG LABEL	1