Application 017854

Type: NDA
Sponsor: ANI PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	REGLAN	METOCLOPRAMIDE HYDROCHLORIDE	TABLET;ORAL	EQ 10MG BASE	Yes	Yes
002	REGLAN	METOCLOPRAMIDE HYDROCHLORIDE	TABLET;ORAL	EQ 5MG BASE	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N017854-001	REGLAN	METOCLOPRAMIDE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	RLD, RS, Approved before 1982
N017854-002	REGLAN	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	RLD	1987-05-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N017854-001	AB
N017854-002	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 2 of 3 · 88 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
2019-12-13 00:20 UTC	2019-12	N017854-001	REGLAN	EQ 10MG BASE	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N017854-002	REGLAN	EQ 5MG BASE	TABLET / ORAL	AB	RLD	1987-05-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N017854-001	REGLAN	EQ 10MG BASE	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N017854-002	REGLAN	EQ 5MG BASE	TABLET / ORAL	AB	RLD	1987-05-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N017854-001	REGLAN	EQ 10MG BASE	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N017854-002	REGLAN	EQ 5MG BASE	TABLET / ORAL	AB	RLD	1987-05-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017854-001	REGLAN	EQ 10MG BASE	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017854-002	REGLAN	EQ 5MG BASE	TABLET / ORAL	AB	RLD	1987-05-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N017854-001	REGLAN	EQ 10MG BASE	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N017854-002	REGLAN	EQ 5MG BASE	TABLET / ORAL	AB	RLD	1987-05-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N017854-001	REGLAN	EQ 10MG BASE	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N017854-002	REGLAN	EQ 5MG BASE	TABLET / ORAL	AB	RLD	1987-05-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N017854-001	REGLAN	EQ 10MG BASE	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N017854-002	REGLAN	EQ 5MG BASE	TABLET / ORAL	AB	RLD	1987-05-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N017854-001	REGLAN	EQ 10MG BASE	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N017854-002	REGLAN	EQ 5MG BASE	TABLET / ORAL	AB	RLD	1987-05-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N017854-001	REGLAN	EQ 10MG BASE	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N017854-002	REGLAN	EQ 5MG BASE	TABLET / ORAL	AB	RLD	1987-05-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N017854-001	REGLAN	EQ 10MG BASE	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N017854-002	REGLAN	EQ 5MG BASE	TABLET / ORAL	AB	RLD	1987-05-05	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N017854-001	REGLAN	EQ 10MG BASE	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N017854-002	REGLAN	EQ 5MG BASE	TABLET / ORAL	AB	RLD	1987-05-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N017854-001	REGLAN	EQ 10MG BASE	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N017854-002	REGLAN	EQ 5MG BASE	TABLET / ORAL	AB	RLD	1987-05-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N017854-001	REGLAN	EQ 10MG BASE	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N017854-002	REGLAN	EQ 5MG BASE	TABLET / ORAL	AB	RLD	1987-05-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N017854-001	REGLAN	EQ 10MG BASE	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N017854-002	REGLAN	EQ 5MG BASE	TABLET / ORAL	AB	RLD	1987-05-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N017854-001	REGLAN	EQ 10MG BASE	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N017854-002	REGLAN	EQ 5MG BASE	TABLET / ORAL	AB	RLD	1987-05-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N017854-001	REGLAN	EQ 10MG BASE	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N017854-002	REGLAN	EQ 5MG BASE	TABLET / ORAL	AB	RLD	1987-05-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N017854-001	REGLAN	EQ 10MG BASE	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N017854-002	REGLAN	EQ 5MG BASE	TABLET / ORAL	AB	RLD	1987-05-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N017854-001	REGLAN	EQ 10MG BASE	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N017854-002	REGLAN	EQ 5MG BASE	TABLET / ORAL	AB	RLD	1987-05-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N017854-001	REGLAN	EQ 10MG BASE	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N017854-002	REGLAN	EQ 5MG BASE	TABLET / ORAL	AB	RLD	1987-05-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N017854-001	REGLAN	EQ 10MG BASE	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N017854-002	REGLAN	EQ 5MG BASE	TABLET / ORAL	AB	RLD	1987-05-05	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N017854-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N017854-002	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N017854-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N017854-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N017854-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017854-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N017854-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017854-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017854-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017854-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017854-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017854-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017854-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017854-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017854-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017854-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017854-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017854-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017854-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017854-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017854-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017854-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017854-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017854-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017854-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N017854-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017854-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017854-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017854-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017854-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017854-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017854-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N017854-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N017854-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017854-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017854-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N017854-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N017854-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N017854-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N017854-002	AB	1	`4b0b4de00fa7…`

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	ANI Pharmaceuticals, Inc.	797aad80-0597-42f8-99d5-39de180c3b5a	2026-05-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 017854 application number: NDA017854 ndc (product): 62559-296 ndc (product): 62559-295
Reglan	METOCLOPRAMIDE HYDROCHLORIDE	ANI Pharmaceuticals, Inc.	de55c133-eb08-4a35-91a2-5dc093027397	2026-02-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 017854 application number: NDA017854 ndc (product): 62559-166 ndc (product): 62559-165
Metoclopramide	METOCLOPRAMIDE	Redpharm Drug	49eb807b-fa34-3d84-e063-6394a90acfcf	2026-02-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 017854 application number: NDA017854

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
62559-165	Reglan	Metoclopramide Hydrochloride	ANI Pharmaceuticals, Inc.	NDA	Current
62559-165	Reglan	Metoclopramide Hydrochloride	ANI Pharmaceuticals, Inc.	NDA	Current
62559-165	Reglan	Metoclopramide Hydrochloride	ANI Pharmaceuticals, Inc.	NDA	Current
62559-166	Reglan	Metoclopramide Hydrochloride	ANI Pharmaceuticals, Inc.	NDA	Current
62559-166	Reglan	Metoclopramide Hydrochloride	ANI Pharmaceuticals, Inc.	NDA	Current
62559-166	Reglan	Metoclopramide Hydrochloride	ANI Pharmaceuticals, Inc.	NDA	Current
62559-295	Metoclopramide	Metoclopramide	ANI Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
62559-296	Metoclopramide	Metoclopramide	ANI Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85001	SUPPL	2026-02-11
85000	SUPPL	2026-02-11
84976	SUPPL	2026-02-10
49633	SUPPL	2017-08-30
49582	SUPPL	2017-08-30
23108	ORIG	2011-12-20
13930	SUPPL	2011-09-26
11078	SUPPL	2011-09-23
13929	SUPPL	2011-08-05
40762	SUPPL	2011-01-04
33363	SUPPL	2010-11-26
13928	SUPPL	2010-11-22
723	SUPPL	2009-10-26
11077	SUPPL	2009-10-08
11076	SUPPL	2009-09-22
722	SUPPL	2009-07-06
33362	SUPPL	2004-07-28
13927	SUPPL	2004-07-28
13926	SUPPL	2003-05-29
13925	SUPPL	2003-05-29
13923	SUPPL	2003-05-29
13924	SUPPL	2002-11-25
20093	SUPPL	2001-06-18