Application 073135

Type: ANDA
Sponsor: TEVA PHARMS USA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	METOCLOPRAMIDE HYDROCHLORIDE	METOCLOPRAMIDE HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 5MG BASE/ML	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
A073135-001	METOCLOPRAMIDE HYDROCHLORIDE	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP		1991-11-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A073135-001	AP

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	A073135-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	1991-11-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A073135-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	1991-11-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A073135-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	1991-11-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A073135-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	1991-11-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A073135-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	1991-11-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A073135-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	1991-11-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A073135-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	1991-11-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A073135-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	1991-11-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A073135-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	1991-11-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A073135-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	1991-11-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A073135-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	1991-11-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A073135-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	1991-11-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A073135-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	1991-11-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A073135-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	1991-11-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A073135-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	1991-11-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A073135-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	1991-11-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A073135-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	1991-11-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A073135-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	1991-11-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A073135-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	1991-11-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A073135-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	1991-11-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A073135-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	1991-11-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A073135-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	1991-11-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A073135-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	1991-11-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A073135-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	1991-11-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A073135-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	1991-11-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A073135-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	1991-11-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A073135-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	1991-11-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A073135-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	1991-11-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A073135-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	1991-11-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A073135-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	1991-11-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A073135-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	1991-11-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A073135-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	1991-11-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A073135-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	1991-11-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A073135-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	1991-11-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A073135-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	1991-11-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A073135-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	1991-11-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A073135-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	1991-11-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A073135-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	1991-11-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A073135-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	1991-11-27	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A073135-001	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	1991-11-27	`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	A073135-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A073135-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A073135-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A073135-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A073135-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A073135-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A073135-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A073135-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A073135-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A073135-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A073135-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A073135-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A073135-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A073135-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A073135-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A073135-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A073135-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A073135-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A073135-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A073135-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A073135-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A073135-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A073135-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A073135-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A073135-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A073135-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A073135-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A073135-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A073135-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A073135-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A073135-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A073135-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A073135-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A073135-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A073135-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A073135-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A073135-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A073135-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A073135-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A073135-001	AP	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	Teva Parenteral Medicines, Inc.	cccf04bd-7463-40b8-a41f-cb1093c358d7	2026-04-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073135 application number: ANDA073135 ndc (product): 0703-4502
Metoclopramide	METOCLOPRAMIDE	Teva Parenteral Medicines, Inc.	5645a752-8868-4b51-8b59-48bb4276d763	2026-04-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073135 application number: ANDA073135 ndc (product): 0703-4502
Metoclopramide	METOCLOPRAMIDE	Cardinal Health 107, LLC	1ecab710-8b7d-4903-80a8-de66562be55a	2025-10-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073135 application number: ANDA073135 ndc (product): 55154-0450

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0703-4502	Metoclopramide	Metoclopramide	Teva Parenteral Medicines, Inc.	ANDA	Current
0703-4502	Metoclopramide	Metoclopramide	Teva Parenteral Medicines, Inc.	ANDA	Current
0703-4502	Metoclopramide	Metoclopramide	Teva Parenteral Medicines, Inc.	ANDA	Current
0703-4502	Metoclopramide	Metoclopramide	Teva Parenteral Medicines, Inc.	ANDA	Current
0703-4502	Metoclopramide	Metoclopramide	Teva Parenteral Medicines, Inc.	ANDA	Current
0703-4502	Metoclopramide	Metoclopramide	Teva Parenteral Medicines, Inc.	ANDA	Current
55154-0450	Metoclopramide hydrochloride	Metoclopramide hydrochloride	Cardinal Health	ANDA	Current
55154-0450	Metoclopramide hydrochloride	Metoclopramide hydrochloride	Cardinal Health	ANDA	Current
55154-0450	Metoclopramide hydrochloride	Metoclopramide hydrochloride	Cardinal Health	ANDA	Current
71872-7075	Metoclopramide	Metoclopramide	Medical Purchasing Solutions, LLC	ANDA	Current
71872-7075	Metoclopramide	Metoclopramide	Medical Purchasing Solutions, LLC	ANDA	Current