Application 040889

Type: ANDA
Sponsor: BRECKENRIDGE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	METHYLERGONOVINE MALEATE	METHYLERGONOVINE MALEATE	INJECTABLE;INJECTION	0.2MG/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
A040889-001	METHYLERGONOVINE MALEATE	METHYLERGONOVINE MALEATE	0.2MG/ML	INJECTABLE / INJECTION	AP		2010-09-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040889-001	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	A040889-001	METHYLERGONOVINE MALEATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2010-09-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040889-001	METHYLERGONOVINE MALEATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2010-09-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040889-001	METHYLERGONOVINE MALEATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2010-09-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040889-001	METHYLERGONOVINE MALEATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2010-09-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040889-001	METHYLERGONOVINE MALEATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2010-09-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040889-001	METHYLERGONOVINE MALEATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2010-09-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040889-001	METHYLERGONOVINE MALEATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2010-09-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040889-001	METHYLERGONOVINE MALEATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2010-09-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040889-001	METHYLERGONOVINE MALEATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2010-09-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040889-001	METHYLERGONOVINE MALEATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2010-09-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040889-001	METHYLERGONOVINE MALEATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2010-09-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040889-001	METHYLERGONOVINE MALEATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2010-09-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040889-001	METHYLERGONOVINE MALEATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2010-09-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040889-001	METHYLERGONOVINE MALEATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2010-09-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040889-001	METHYLERGONOVINE MALEATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2010-09-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040889-001	METHYLERGONOVINE MALEATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2010-09-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040889-001	METHYLERGONOVINE MALEATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2010-09-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040889-001	METHYLERGONOVINE MALEATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2010-09-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040889-001	METHYLERGONOVINE MALEATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2010-09-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040889-001	METHYLERGONOVINE MALEATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2010-09-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040889-001	METHYLERGONOVINE MALEATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2010-09-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040889-001	METHYLERGONOVINE MALEATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2010-09-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040889-001	METHYLERGONOVINE MALEATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2010-09-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040889-001	METHYLERGONOVINE MALEATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2010-09-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040889-001	METHYLERGONOVINE MALEATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2010-09-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040889-001	METHYLERGONOVINE MALEATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2010-09-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040889-001	METHYLERGONOVINE MALEATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2010-09-13	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040889-001	METHYLERGONOVINE MALEATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2010-09-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040889-001	METHYLERGONOVINE MALEATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2010-09-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040889-001	METHYLERGONOVINE MALEATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2010-09-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040889-001	METHYLERGONOVINE MALEATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2010-09-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040889-001	METHYLERGONOVINE MALEATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2010-09-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040889-001	METHYLERGONOVINE MALEATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2010-09-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040889-001	METHYLERGONOVINE MALEATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2010-09-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040889-001	METHYLERGONOVINE MALEATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2010-09-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040889-001	METHYLERGONOVINE MALEATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2010-09-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040889-001	METHYLERGONOVINE MALEATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2010-09-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040889-001	METHYLERGONOVINE MALEATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2010-09-13	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040889-001	METHYLERGONOVINE MALEATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2010-09-13	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040889-001	METHYLERGONOVINE MALEATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2010-09-13	`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	A040889-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040889-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040889-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040889-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040889-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040889-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040889-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040889-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040889-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040889-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040889-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040889-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040889-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040889-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040889-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040889-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040889-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040889-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040889-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040889-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040889-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040889-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040889-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040889-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040889-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040889-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040889-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040889-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040889-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040889-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040889-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040889-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040889-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040889-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040889-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040889-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040889-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040889-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040889-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040889-001	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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
METHYLERGONOVINE MALEATE	METHYLERGONOVINE MALEATE	Pharmacist Pharmaceutical, LLC	17ee0c79-ac98-4400-ae77-985978fca07e	2025-12-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040889 application number: ANDA040889 ndc (product): 63704-004
METHYLERGONOVINE MALEATE	METHYLERGONOVINE MALEATE	Breckenridge Pharmaceutical, Inc.	8bccff44-2a39-400a-b8a4-2eb5249fdbc8	2025-07-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040889 application number: ANDA040889 ndc (product): 51991-144
METHYLERGONOVINE MALEATE	METHYLERGONOVINE MALEATE	Bryant Ranch Prepack	885b98d9-ba2c-48fb-b3b8-940e5f5e93d6	2024-05-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040889 application number: ANDA040889
METHYLERGONOVINE MALEATE	METHYLERGONOVINE MALEATE	Bryant Ranch Prepack	8a6fe76c-d709-419e-885e-fa2ce07df27b	2024-05-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040889 application number: ANDA040889 ndc (product): 63629-2074
METHYLERGONOVINE MALEATE	METHYLERGONOVINE MALEATE	HF Acquisition Co LLC, DBA HealthFirst	c4c48277-eb9e-6150-e053-2a95a90ab21d	2024-05-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040889 application number: ANDA040889 ndc (product): 51662-1556

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
17478-501	Methylergonovine Maleate	Methylergonovine Maleate	Akorn, Inc.	ANDA	Current
17478-501	Methylergonovine Maleate	Methylergonovine Maleate	Akorn	ANDA	Current
17478-501	Methylergonovine Maleate	Methylergonovine Maleate	Akorn, Inc.	ANDA	Current
17478-501	Methylergonovine Maleate	Methylergonovine Maleate	Akorn, Inc.	ANDA	Current
17478-501	Methylergonovine Maleate	Methylergonovine Maleate	Akorn	ANDA	Current
50090-4536	METHYLERGONOVINE MALEATE	Methylergonovine Maleate	A-S Medication Solutions	ANDA	Current
50090-4536	METHYLERGONOVINE MALEATE	Methylergonovine Maleate	A-S Medication Solutions	ANDA	Current
51662-1556	METHYLERGONOVINE MALEATE	METHYLERGONOVINE MALEATE	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51991-144	METHYLERGONOVINE MALEATE	Methylergonovine Maleate	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-144	METHYLERGONOVINE MALEATE	Methylergonovine Maleate	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-144	METHYLERGONOVINE MALEATE	Methylergonovine Maleate	Breckenridge Pharmaceutical, Inc.	ANDA	Current
63629-2074	METHYLERGONOVINE MALEATE	Methylergonovine Maleate	Bryant Ranch Prepack	ANDA	Current
63629-2074	METHYLERGONOVINE MALEATE	Methylergonovine Maleate	Bryant Ranch Prepack	ANDA	Current
63704-004	METHYLERGONOVINE MALEATE	methylergonovine maleate	Pharmacist Pharmaceutical, LLC	ANDA	Current
63704-004	METHYLERGONOVINE MALEATE	methylergonovine maleate	Pharmacist Pharmaceutical, LLC	ANDA	Current