Metoclopramide

Product NDC: 68071-3923
11-digit product format: 680713923
Labeler code: 68071
Product ID: 68071-3923_4524065f-cc18-eeaa-e063-6394a90a3566
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Metoclopramide
Dosage form: TABLET
Route: ORAL
Labeler: NuCare Pharmaceuticals, Inc.
Application: ANDA072801
Marketing category: ANDA
Marketing start: 1993-07-01
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

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
A072801-001	METOCLOPRAMIDE HYDROCHLORIDE	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB		1993-06-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A072801-001	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 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	A072801-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	1993-06-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072801-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	1993-06-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072801-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	1993-06-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072801-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	1993-06-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072801-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	1993-06-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072801-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	1993-06-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072801-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	1993-06-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072801-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	1993-06-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072801-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	1993-06-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072801-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	1993-06-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072801-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	1993-06-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072801-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	1993-06-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072801-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	1993-06-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A072801-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	1993-06-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072801-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	1993-06-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A072801-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	1993-06-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A072801-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	1993-06-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A072801-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	1993-06-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A072801-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	1993-06-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A072801-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	1993-06-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A072801-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	1993-06-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A072801-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	1993-06-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A072801-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	1993-06-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A072801-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	1993-06-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A072801-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	1993-06-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A072801-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	1993-06-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A072801-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	1993-06-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A072801-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	1993-06-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A072801-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	1993-06-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A072801-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	1993-06-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A072801-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	1993-06-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A072801-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	1993-06-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A072801-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	1993-06-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A072801-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	1993-06-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A072801-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	1993-06-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A072801-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	1993-06-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A072801-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	1993-06-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A072801-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	1993-06-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A072801-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	1993-06-15	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A072801-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	1993-06-15	`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	A072801-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072801-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072801-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072801-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072801-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072801-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072801-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072801-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072801-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072801-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072801-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072801-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072801-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A072801-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072801-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A072801-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A072801-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A072801-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A072801-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A072801-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A072801-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A072801-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A072801-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A072801-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A072801-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A072801-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A072801-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A072801-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A072801-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A072801-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A072801-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A072801-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A072801-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A072801-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A072801-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A072801-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A072801-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A072801-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A072801-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A072801-001	AB	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/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
311668	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
4524146c-f588-083b-e063-6294a90ac977	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
68071-3923-3	Metoclopramide	30 in 1 BOTTLE	TABLET	30		1

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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metoclopramide	METOCLOPRAMIDE	Cardinal Health 107, LLC	7eeaa7bc-c94f-47d0-94e5-e35ccadca19e	2026-06-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072801 application number: ANDA072801
Metoclopramide	METOCLOPRAMIDE	Coupler LLC	5345a125-0cee-472e-e063-6394a90aeb21	2026-06-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072801 application number: ANDA072801
Metoclopramide	METOCLOPRAMIDE	Safecor Health LLC	15d616d7-2f4c-4882-a03c-fcc86c18f5f8	2026-05-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072801 application number: ANDA072801
Metoclopramide	METOCLOPRAMIDE	Teva Pharmaceuticals USA, Inc.	e15905e0-e0f6-4c8b-ac19-59724d6c4bf0	2026-03-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072801 application number: ANDA072801
Metoclopramide	METOCLOPRAMIDE	NuCare Pharmaceuticals, Inc.	4524146c-f588-083b-e063-6294a90ac977	2025-12-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072801 application number: ANDA072801 ndc (product): 68071-3923
Metoclopramide	METOCLOPRAMIDE	Mylan Institutional Inc.	447dbb34-7903-4e6a-be31-48a0b0e0d2f5	2025-07-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072801 application number: ANDA072801
Metoclopramide	METOCLOPRAMIDE	NCS HealthCare of KY, LLC dba Vangard Labs	4ab8ddab-8226-4b5a-8774-308ed49d6bc4	2025-06-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072801 application number: ANDA072801
Metoclopramide	METOCLOPRAMIDE	American Health Packaging	998f1782-bbfa-469b-9fe1-c612e8588f70	2024-09-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072801 application number: ANDA072801
Metoclopramide	METOCLOPRAMIDE	NuCare Pharmaceuticals, Inc.	46dcafbc-9d50-316a-e054-00144ff88e88	2024-08-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072801 application number: ANDA072801
Metoclopramide	METOCLOPRAMIDE	Bryant Ranch Prepack	6f0a13cc-9346-4f4a-9a0d-b725045b01aa	2024-05-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072801 application number: ANDA072801

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
311668	metoclopramide HCl 5 MG Oral Tablet	PSN	4524146c-f588-083b-e063-6294a90ac977	1
311668	metoclopramide 5 MG Oral Tablet	SCD	4524146c-f588-083b-e063-6294a90ac977	1
311668	metoclopramide 5 MG (as metoclopramide hydrochloride) Oral Tablet	SY	4524146c-f588-083b-e063-6294a90ac977	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
68071-3923-3	68071392303	30 TABLET in 1 BOTTLE (68071-3923-3)	30 tablet	2025-12-04	No	No	Current