METOCLOPRAMIDE hydrochloride

Product NDC: 43386-581
Requested package NDC: 43386-581-31
11-digit product format: 433860581
Labeler code: 43386
Product ID: 43386-581_b5844be2-94b3-3e3f-e053-2995a90a6eb8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Metoclopramide Hydrochloride
Dosage form: TABLET, ORALLY DISINTEGRATING
Route: ORAL
Labeler: Lupin Pharmaceuticals,Inc.
Application: ANDA202191
Marketing category: ANDA
Marketing start: 2015-04-06
Substance: METOCLOPRAMIDE HYDROCHLORIDE
Active strength: 5 mg/1
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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 1 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	43386-581	43386-581-31	E	Excluded after deficient or non-compliant submission was not corrected		excluded / ndc_excluded.zip	`110d247fa046…`	`a55b01930146…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A202191-001	METOCLOPRAMIDE HYDROCHLORIDE	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL			2014-08-15
A202191-002	METOCLOPRAMIDE HYDROCHLORIDE	METOCLOPRAMIDE HYDROCHLORIDE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		RS	2014-08-15

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 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A202191-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		2014-08-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202191-002	METOCLOPRAMIDE HYDROCHLORIDE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RS	2014-08-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202191-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		2014-08-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202191-002	METOCLOPRAMIDE HYDROCHLORIDE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RS	2014-08-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202191-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		2014-08-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202191-002	METOCLOPRAMIDE HYDROCHLORIDE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RS	2014-08-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202191-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		2014-08-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202191-002	METOCLOPRAMIDE HYDROCHLORIDE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RS	2014-08-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202191-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		2014-08-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202191-002	METOCLOPRAMIDE HYDROCHLORIDE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RS	2014-08-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202191-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		2014-08-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202191-002	METOCLOPRAMIDE HYDROCHLORIDE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RS	2014-08-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202191-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		2014-08-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202191-002	METOCLOPRAMIDE HYDROCHLORIDE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RS	2014-08-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202191-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		2014-08-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202191-002	METOCLOPRAMIDE HYDROCHLORIDE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RS	2014-08-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202191-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		2014-08-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202191-002	METOCLOPRAMIDE HYDROCHLORIDE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RS	2014-08-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202191-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		2014-08-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202191-002	METOCLOPRAMIDE HYDROCHLORIDE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RS	2014-08-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202191-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		2014-08-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202191-002	METOCLOPRAMIDE HYDROCHLORIDE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RS	2014-08-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202191-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		2014-08-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202191-002	METOCLOPRAMIDE HYDROCHLORIDE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RS	2014-08-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202191-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		2014-08-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202191-002	METOCLOPRAMIDE HYDROCHLORIDE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RS	2014-08-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202191-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		2014-08-15	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202191-002	METOCLOPRAMIDE HYDROCHLORIDE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RS	2014-08-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202191-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		2014-08-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202191-002	METOCLOPRAMIDE HYDROCHLORIDE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RS	2014-08-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202191-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		2014-08-15	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202191-002	METOCLOPRAMIDE HYDROCHLORIDE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RS	2014-08-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202191-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		2014-08-15	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202191-002	METOCLOPRAMIDE HYDROCHLORIDE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RS	2014-08-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202191-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		2014-08-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202191-002	METOCLOPRAMIDE HYDROCHLORIDE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RS	2014-08-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202191-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		2014-08-15	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202191-002	METOCLOPRAMIDE HYDROCHLORIDE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RS	2014-08-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202191-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		2014-08-15	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202191-002	METOCLOPRAMIDE HYDROCHLORIDE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RS	2014-08-15	`782e0a99824c…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
METOCLOPRAMIDE HYDROCHLORIDE	5 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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
608623	Internal RxNorm lookup
608624	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
7cd1dc35-2fb2-4f1d-8769-24c3c3aa34fa	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
43386-581-31	METOCLOPRAMIDE hydrochloride	1 in 1 CARTON	TABLET, ORALLY DISINTEGRATING	1		3
43386-581-31	METOCLOPRAMIDE hydrochloride	10 in 1 BLISTER PACK	TABLET, ORALLY DISINTEGRATING	10		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43386-581-30	EA - Each	43386-581	a391f1dd-4774-4a68-a61c-497d96996d42	1	2015-05-05
43386-581-31	EA - Each	43386-581	40cb0e88-407f-4a26-a332-2fbab74ff991	1	2017-09-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43386-581	METOCLOPRAMIDE HYDROCHLORIDE TABLET, ORALLY DISINTEGRATING [LUPIN PHARMACEUTICALS,INC.]	3	Current NDC, Legacy NDC, 2 package rows	20201203_7cd1dc35-2fb2-4f1d-8769-24c3c3aa34fa.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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
METOCLOPRAMIDE hydrochloride	METOCLOPRAMIDE HYDROCHLORIDE	Lupin Pharmaceuticals,Inc.	7cd1dc35-2fb2-4f1d-8769-24c3c3aa34fa	2020-12-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202191 application number: ANDA202191 ndc (package): 43386-581-31 ndc (product): 43386-581 ndc11 (package): 43386058131

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
608623	metoclopramide HCl 10 MG Disintegrating Oral Tablet	PSN	7cd1dc35-2fb2-4f1d-8769-24c3c3aa34fa	3
608624	metoclopramide HCl 5 MG Disintegrating Oral Tablet	PSN	7cd1dc35-2fb2-4f1d-8769-24c3c3aa34fa	3
608623	metoclopramide 10 MG Disintegrating Oral Tablet	SCD	7cd1dc35-2fb2-4f1d-8769-24c3c3aa34fa	3
608624	metoclopramide 5 MG Disintegrating Oral Tablet	SCD	7cd1dc35-2fb2-4f1d-8769-24c3c3aa34fa	3
608623	metoclopramide 10 MG (metoclopramide hydrochloride 11.82 MG) Disintegrating Oral Tablet	SY	7cd1dc35-2fb2-4f1d-8769-24c3c3aa34fa	3
608624	metoclopramide 5 MG (as metoclopramide HCl 5.91 MG) Disintegrating Oral Tablet	SY	7cd1dc35-2fb2-4f1d-8769-24c3c3aa34fa	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
43386-581-31	43386058131	1 BLISTER PACK in 1 CARTON (43386-581-31) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK	1 blister pack	2015-04-06	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
METOCLOPRAMIDE hydrochloride	Lupin Pharmaceuticals,Inc. \| Novel Laboratories, Inc.	2020-12-02	HUMAN PRESCRIPTION DRUG LABEL	3