Application 072744

Type: ANDA
Sponsor: PHARM ASSOC

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
A072744-001	METOCLOPRAMIDE HYDROCHLORIDE	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	RS	1991-05-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A072744-001	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A072744-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	RS	1991-05-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072744-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	RS	1991-05-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072744-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	RS	1991-05-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072744-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	RS	1991-05-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072744-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	RS	1991-05-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072744-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	RS	1991-05-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072744-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	RS	1991-05-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072744-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	RS	1991-05-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072744-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	RS	1991-05-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072744-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	RS	1991-05-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072744-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	RS	1991-05-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072744-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	RS	1991-05-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072744-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	RS	1991-05-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A072744-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	RS	1991-05-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072744-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA		1991-05-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A072744-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA		1991-05-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A072744-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA		1991-05-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A072744-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA		1991-05-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A072744-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA		1991-05-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A072744-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA		1991-05-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A072744-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA		1991-05-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A072744-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA		1991-05-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A072744-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA		1991-05-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A072744-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA		1991-05-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A072744-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA		1991-05-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A072744-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA		1991-05-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A072744-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA		1991-05-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A072744-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	RS	1991-05-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A072744-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	RS	1991-05-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A072744-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	RS	1991-05-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A072744-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	RS	1991-05-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A072744-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	RS	1991-05-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A072744-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA		1991-05-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A072744-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA		1991-05-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A072744-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA		1991-05-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A072744-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA		1991-05-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A072744-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA		1991-05-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A072744-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA		1991-05-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A072744-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA		1991-05-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A072744-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA		1991-05-28	`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	A072744-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072744-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072744-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072744-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072744-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072744-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072744-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072744-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072744-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072744-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072744-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072744-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072744-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A072744-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072744-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A072744-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A072744-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A072744-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A072744-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A072744-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A072744-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A072744-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A072744-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A072744-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A072744-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A072744-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A072744-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A072744-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A072744-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A072744-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A072744-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A072744-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A072744-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A072744-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A072744-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A072744-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A072744-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A072744-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A072744-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A072744-001	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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metoclopramide	METOCLOPRAMIDE HYDROCHLORIDE	ATLANTIC BIOLOGICALS CORP.	3cd4b274-6176-4e5b-9765-4f50763bd58f	2026-07-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072744 application number: ANDA072744 ndc (product): 17856-0576
Metoclopramide	METOCLOPRAMIDE HYDROCHLORIDE	PAI Holdings, LLC dba PAI Pharma	3cc8ca5b-8b71-4c77-a181-9ce154597b9a	2024-11-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072744 application number: ANDA072744 ndc (product): 0121-1576 ndc (product): 0121-0576
Metoclopramide	METOCLOPRAMIDE HYDROCHLORIDE	Genus Lifesciences Inc.	74358569-7a24-4a59-a7fc-500d2341d6cb	2024-05-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072744 application number: ANDA072744

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0121-0576	Metoclopramide	metoclopramide hydrochloride	Pharmaceutical Associates, Inc.	ANDA	Current
0121-0576	Metoclopramide	metoclopramide hydrochloride	Pharmaceutical Associates, Inc.	ANDA	Current
0121-0576	Metoclopramide	metoclopramide hydrochloride	Pharmaceutical Associates, Inc.	ANDA	Current
0121-1576	Metoclopramide	metoclopramide hydrochloride	Pharmaceutical Associates, Inc.	ANDA	Current
0121-1576	Metoclopramide	metoclopramide hydrochloride	Pharmaceutical Associates, Inc.	ANDA	Current
0121-1576	Metoclopramide	metoclopramide hydrochloride	Pharmaceutical Associates, Inc.	ANDA	Current
17856-0537	Metoclopramide	metoclopramide hydrochloride	Atlantic Biologicals Corps	ANDA	Current
17856-0537	Metoclopramide	metoclopramide hydrochloride	Atlantic Biologicals Corps	ANDA	Current
17856-0576	Metoclopramide	metoclopramide hydrochloride	Atlantic Biologicals Corps	ANDA	Current
17856-0576	Metoclopramide	metoclopramide hydrochloride	Atlantic Biologicals Corps	ANDA	Current
17856-3727	Metoclopramide	metoclopramide hydrochloride	Atlantic Biologicals Corps	ANDA	Current
50436-0576	Metoclopramide	metoclopramide hydrochloride	Unit Dose Services	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
42827	SUPPL	2011-12-02
42826	SUPPL	2011-12-02