Methylergonovine Maleate

Product NDC: 17478-501
Requested package NDC: 17478-501-01
11-digit product format: 174780501
Labeler code: 17478
Product ID: 17478-501_a6a08cce-de2f-4a0f-9185-f8583f207113
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Methylergonovine Maleate
Dosage form: INJECTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: Akorn
Application: ANDA040889
Marketing category: ANDA
Marketing start: 2011-03-02
Marketing end: 2022-12-31
Substance: METHYLERGONOVINE MALEATE
Active strength: 0 mg/mL
Pharmacologic classes: Ergolines [CS], Ergot Derivative [EPC]
NDC exclude flag: No
Listing certified through: 0000-00-00
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	17478-501	17478-501-01	D	Discontinued by firm		2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
17478-501-01	ML - Milliliter	17478-501	7221ccb1-77c8-44f0-8c68-edcc96fd4326	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Methylergonovine Maleate	ACTIVE INGREDIENT	IR84JPZ1RK	METHYLERGONOVINE MALEATE INJECTION [AKORN, INC.]	4
Methylergonovine	ACTIVE MOIETY	W53L6FE61V	METHYLERGONOVINE MALEATE INJECTION [AKORN, INC.]	4
Maleic Acid	INACTIVE INGREDIENT	91XW058U2C	METHYLERGONOVINE MALEATE INJECTION [AKORN, INC.]	4
Sodium Chloride	INACTIVE INGREDIENT	451W47IQ8X	METHYLERGONOVINE MALEATE INJECTION [AKORN, INC.]	4
Water	INACTIVE INGREDIENT	059QF0KO0R	METHYLERGONOVINE MALEATE INJECTION [AKORN, INC.]	4

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
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
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
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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
IR84JPZ1RK	METHYLERGONOVINE MALEATE	57432-61-8	METHYLERGONOVINE MALEATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
17478-501-01	17478050101	10 AMPULE in 1 CARTON (17478-501-01) > 1 mL in 1 AMPULE	10 ampule	2011-03-02	2022-12-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Methylergonovine Maleate Injection, USP	Akorn \| PRZEDSIEBIORSTWO FARMACEUTYCZNE JELFA S A	2022-09-20	HUMAN PRESCRIPTION DRUG LABEL	9