Application 078807

Type: ANDA
Sponsor: IPCA LABS LTD

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
002	METOCLOPRAMIDE HYDROCHLORIDE	METOCLOPRAMIDE HYDROCHLORIDE	TABLET;ORAL	EQ 10MG 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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A078807-001	METOCLOPRAMIDE HYDROCHLORIDE	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB		2008-06-12
A078807-002	METOCLOPRAMIDE HYDROCHLORIDE	METOCLOPRAMIDE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB		2008-06-12

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A078807-001	AB
A078807-002	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 3 · 82 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	A078807-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2008-06-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078807-002	METOCLOPRAMIDE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2008-06-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078807-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2008-06-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078807-002	METOCLOPRAMIDE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2008-06-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078807-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2008-06-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078807-002	METOCLOPRAMIDE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2008-06-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078807-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2008-06-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078807-002	METOCLOPRAMIDE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2008-06-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078807-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2008-06-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078807-002	METOCLOPRAMIDE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2008-06-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078807-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2008-06-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078807-002	METOCLOPRAMIDE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2008-06-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078807-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2008-06-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078807-002	METOCLOPRAMIDE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2008-06-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078807-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2008-06-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078807-002	METOCLOPRAMIDE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2008-06-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078807-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2008-06-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078807-002	METOCLOPRAMIDE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2008-06-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078807-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2008-06-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078807-002	METOCLOPRAMIDE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2008-06-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078807-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2008-06-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078807-002	METOCLOPRAMIDE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2008-06-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078807-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2008-06-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078807-002	METOCLOPRAMIDE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2008-06-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078807-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2008-06-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078807-002	METOCLOPRAMIDE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2008-06-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078807-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2008-06-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078807-002	METOCLOPRAMIDE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2008-06-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078807-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2008-06-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078807-002	METOCLOPRAMIDE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2008-06-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078807-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2008-06-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078807-002	METOCLOPRAMIDE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2008-06-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078807-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2008-06-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078807-002	METOCLOPRAMIDE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2008-06-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078807-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2008-06-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078807-002	METOCLOPRAMIDE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2008-06-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078807-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2008-06-12	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078807-002	METOCLOPRAMIDE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2008-06-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078807-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2008-06-12	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078807-002	METOCLOPRAMIDE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2008-06-12	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A078807-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078807-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078807-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078807-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078807-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078807-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078807-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078807-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078807-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078807-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078807-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078807-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078807-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078807-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078807-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078807-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078807-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078807-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078807-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078807-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078807-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078807-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078807-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078807-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078807-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078807-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078807-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078807-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078807-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078807-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078807-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078807-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078807-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078807-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078807-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078807-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078807-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078807-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078807-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078807-002	AB	1	`782e0a99824c…`

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	Ipca Laboratories Limited	c143e210-4ce7-44e5-b1e2-bf0e6bfde485	2026-07-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078807 application number: ANDA078807
Metoclopramide	METOCLOPRAMIDE	NuCare Pharmaceuticals, Inc.	548e83bc-898f-6b16-e063-6294a90a1755	2026-06-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078807 application number: ANDA078807

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
63304-845	Metoclopramide	Metoclopramide	Ranbaxy Pharmaceuticals Inc.	ANDA	Current
63304-846	Metoclopramide	Metoclopramide	Ranbaxy Pharmaceuticals Inc.	ANDA	Current
68788-9093	Metoclopramide	Metoclopramide	Preferred Pharmaceuticals, Inc.	ANDA	Current