Application 071402

Type: ANDA
Sponsor: ANI PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	METOCLOPRAMIDE HYDROCHLORIDE	METOCLOPRAMIDE HYDROCHLORIDE	SOLUTION;ORAL	EQ 5MG BASE/5ML	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
A071402-001	METOCLOPRAMIDE HYDROCHLORIDE	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA		1993-06-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A071402-001	AA

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	A071402-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	1993-06-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071402-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	1993-06-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071402-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	1993-06-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071402-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	1993-06-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071402-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	1993-06-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071402-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	1993-06-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071402-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	1993-06-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071402-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	1993-06-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071402-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	1993-06-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071402-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	1993-06-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071402-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	1993-06-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071402-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	1993-06-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071402-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	1993-06-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071402-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	1993-06-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071402-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	1993-06-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071402-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	1993-06-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071402-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	1993-06-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071402-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	1993-06-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071402-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	1993-06-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071402-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	1993-06-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071402-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	1993-06-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071402-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	1993-06-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071402-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	1993-06-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071402-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	1993-06-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071402-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	1993-06-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071402-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	1993-06-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071402-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	1993-06-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071402-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	1993-06-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071402-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	1993-06-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071402-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	1993-06-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071402-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	1993-06-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071402-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	1993-06-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071402-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	1993-06-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071402-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	1993-06-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071402-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	1993-06-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071402-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	1993-06-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071402-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	1993-06-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071402-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	1993-06-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A071402-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	1993-06-25	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A071402-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	1993-06-25	`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	A071402-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071402-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071402-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071402-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071402-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071402-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071402-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071402-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071402-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071402-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071402-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071402-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071402-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071402-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071402-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071402-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071402-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071402-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071402-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071402-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071402-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071402-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071402-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071402-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071402-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071402-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071402-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071402-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071402-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071402-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071402-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071402-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071402-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071402-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071402-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071402-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071402-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071402-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A071402-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A071402-001	AA	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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metoclopramide	METOCLOPRAMIDE	American Health Packaging	0034a97a-fb05-418a-a234-de278907cd2a	2026-07-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071402 application number: ANDA071402
Metoclopramide	METOCLOPRAMIDE	Bryant Ranch Prepack	84ec68c1-efa0-4ed2-9fae-d0cc17b0a6b4	2025-11-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071402 application number: ANDA071402
Metoclopramide	METOCLOPRAMIDE	ATLANTIC BIOLOGICALS CORP.	3ce3245f-7021-5135-e063-6394a90a7d95	2025-08-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071402 application number: ANDA071402
Metoclopramide	METOCLOPRAMIDE	Bryant Ranch Prepack	67024bbc-65d1-428d-a807-46647038daf6	2025-08-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071402 application number: ANDA071402 ndc (product): 63629-1961
Metoclopramide	METOCLOPRAMIDE	Bryant Ranch Prepack	14114420-fee0-4850-b99e-cdb5f421cd33	2025-08-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071402 application number: ANDA071402 ndc (product): 63629-2144
Metoclopramide	METOCLOPRAMIDE	Bryant Ranch Prepack	e34fea34-5fc5-4200-bc9d-f5e558023630	2025-07-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071402 application number: ANDA071402
Metoclopramide	METOCLOPRAMIDE	ANI Pharmaceuticals, Inc.	4e12e98a-06fe-4b3c-bb64-f2701e195c74	2025-06-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071402 application number: ANDA071402 ndc (product): 62559-190
Metoclopramide	METOCLOPRAMIDE	Bryant Ranch Prepack	9530014b-c266-4015-9195-9f100d67317b	2025-02-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071402 application number: ANDA071402

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
62559-190	Metoclopramide	Metoclopramide	ANI Pharmaceuticals, Inc.	ANDA	Current
62559-190	Metoclopramide	Metoclopramide	ANI Pharmaceuticals, Inc.	ANDA	Current
63629-1961	Metoclopramide	Metoclopramide	Bryant Ranch Prepack	ANDA	Current
63629-1961	Metoclopramide	Metoclopramide	Bryant Ranch Prepack	ANDA	Current
63629-2144	Metoclopramide	Metoclopramide	Bryant Ranch Prepack	ANDA	Current
63629-2144	Metoclopramide	Metoclopramide	Bryant Ranch Prepack	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
42824	SUPPL	2011-12-02
42823	SUPPL	2011-12-02