Application 072801

Type: ANDA
Sponsor: TEVA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	METOCLOPRAMIDE HYDROCHLORIDE	METOCLOPRAMIDE HYDROCHLORIDE	TABLET;ORAL	EQ 5MG BASE	No	No

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…`

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 · 11 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 ndc (product): 55154-4383
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 ndc (product): 0093-2204
Metoclopramide	METOCLOPRAMIDE	AvKARE	ff067ac5-6efc-3e86-e6d5-590b2779491c	2026-01-15	Boxed warning, Warnings, Adverse reactions	Exact identifier ndc (product): 42291-595
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
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 ndc (product): 51079-886
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 ndc (product): 0615-7698
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 ndc (product): 60687-620
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 ndc (product): 66267-841
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 ndc (product): 71335-1259

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 26 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-2204	Metoclopramide	Metoclopramide	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-2204	Metoclopramide	Metoclopramide	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-2204	Metoclopramide	Metoclopramide	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-2204	Metoclopramide	Metoclopramide	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-2204	Metoclopramide	Metoclopramide	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0615-7698	Metoclopramide	Metoclopramide	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-7698	Metoclopramide	Metoclopramide	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-7698	Metoclopramide	Metoclopramide	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
42291-595	Metoclopramide	Metoclopramide	AvKARE, Inc.	ANDA	Current
42291-595	Metoclopramide	Metoclopramide	AvKARE	ANDA	Current
49999-758	Metoclopramide	Metoclopramide	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
50436-1873	Metoclopramide	Metoclopramide	Unit Dose Services	ANDA	Current
51079-886	Metoclopramide	Metoclopramide	Mylan Institutional Inc.	ANDA	Current
51079-886	Metoclopramide	Metoclopramide	Mylan Institutional Inc.	ANDA	Current
55154-4383	Metoclopramide	Metoclopramide	Cardinal Health	ANDA	Current
55154-4383	Metoclopramide	Metoclopramide	Cardinal Health	ANDA	Current
55154-4383	Metoclopramide	Metoclopramide	Cardinal Health	ANDA	Current
55154-4383	Metoclopramide	Metoclopramide	Cardinal Health 107, LLC	ANDA	Current
60687-620	Metoclopramide	Metoclopramide	American Health Packaging	ANDA	Current
60687-620	Metoclopramide	Metoclopramide	American Health Packaging	ANDA	Current
61919-150	METOCLOPRAMIDE HYDROCHLORIDE	METOCLOPRAMIDE HYDROCHLORIDE	DIRECT RX	ANDA	Current
61919-150	METOCLOPRAMIDE HYDROCHLORIDE	METOCLOPRAMIDE HYDROCHLORIDE	DIRECT RX	ANDA	Current
66267-841	Metoclopramide	Metoclopramide	NuCare Pharmaceuticals, Inc.	ANDA	Current
66267-841	Metoclopramide	Metoclopramide	NuCare Pharmaceuticals, Inc.	ANDA	Current
68151-1741	Metoclopramide	Metoclopramide	Carilion Materials Management	ANDA	Current
71335-1259	Metoclopramide	Metoclopramide	Bryant Ranch Prepack	ANDA	Current