METHYLERGONOVINE MALEATE

Product NDC: 51662-1668
11-digit product format: 516621668
Labeler code: 51662
Product ID: 51662-1668_4ddcdfff-1469-bff0-e063-6294a90a5480
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: METHYLERGONOVINE MALEATE
Dosage form: INJECTION, SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: HF Acquisition Co. LLC. DBA HealthFirst
Application: ANDA090193
Marketing category: ANDA
Marketing start: 2010-06-21
Substance: METHYLERGONOVINE MALEATE
Active strength: .2 mg/mL
Pharmacologic classes: Ergolines [CS], Ergot Derivative [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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
A090193-001	METHYLERGONOVINE MALEATE	METHYLERGONOVINE MALEATE	0.2MG/ML	INJECTABLE / INJECTION	AP	RS	2008-11-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090193-001	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090193-001	METHYLERGONOVINE MALEATE	0.2MG/ML	INJECTABLE / INJECTION	AP	RS	2008-11-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090193-001	METHYLERGONOVINE MALEATE	0.2MG/ML	INJECTABLE / INJECTION	AP	RS	2008-11-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090193-001	METHYLERGONOVINE MALEATE	0.2MG/ML	INJECTABLE / INJECTION	AP	RS	2008-11-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090193-001	METHYLERGONOVINE MALEATE	0.2MG/ML	INJECTABLE / INJECTION	AP	RS	2008-11-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090193-001	METHYLERGONOVINE MALEATE	0.2MG/ML	INJECTABLE / INJECTION	AP	RS	2008-11-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090193-001	METHYLERGONOVINE MALEATE	0.2MG/ML	INJECTABLE / INJECTION	AP	RS	2008-11-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090193-001	METHYLERGONOVINE MALEATE	0.2MG/ML	INJECTABLE / INJECTION	AP		2008-11-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090193-001	METHYLERGONOVINE MALEATE	0.2MG/ML	INJECTABLE / INJECTION	AP		2008-11-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090193-001	METHYLERGONOVINE MALEATE	0.2MG/ML	INJECTABLE / INJECTION	AP		2008-11-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090193-001	METHYLERGONOVINE MALEATE	0.2MG/ML	INJECTABLE / INJECTION	AP		2008-11-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090193-001	METHYLERGONOVINE MALEATE	0.2MG/ML	INJECTABLE / INJECTION	AP		2008-11-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090193-001	METHYLERGONOVINE MALEATE	0.2MG/ML	INJECTABLE / INJECTION	AP		2008-11-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090193-001	METHYLERGONOVINE MALEATE	0.2MG/ML	INJECTABLE / INJECTION	AP		2008-11-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090193-001	METHYLERGONOVINE MALEATE	0.2MG/ML	INJECTABLE / INJECTION	AP		2008-11-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090193-001	METHYLERGONOVINE MALEATE	0.2MG/ML	INJECTABLE / INJECTION	AP		2008-11-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090193-001	METHYLERGONOVINE MALEATE	0.2MG/ML	INJECTABLE / INJECTION	AP		2008-11-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090193-001	METHYLERGONOVINE MALEATE	0.2MG/ML	INJECTABLE / INJECTION	AP		2008-11-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090193-001	METHYLERGONOVINE MALEATE	0.2MG/ML	INJECTABLE / INJECTION	AP		2008-11-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090193-001	METHYLERGONOVINE MALEATE	0.2MG/ML	INJECTABLE / INJECTION	AP		2008-11-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090193-001	METHYLERGONOVINE MALEATE	0.2MG/ML	INJECTABLE / INJECTION	AP		2008-11-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090193-001	METHYLERGONOVINE MALEATE	0.2MG/ML	INJECTABLE / INJECTION	AP		2008-11-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090193-001	METHYLERGONOVINE MALEATE	0.2MG/ML	INJECTABLE / INJECTION	AP		2008-11-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090193-001	METHYLERGONOVINE MALEATE	0.2MG/ML	INJECTABLE / INJECTION	AP		2008-11-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090193-001	METHYLERGONOVINE MALEATE	0.2MG/ML	INJECTABLE / INJECTION	AP		2008-11-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090193-001	METHYLERGONOVINE MALEATE	0.2MG/ML	INJECTABLE / INJECTION	AP		2008-11-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090193-001	METHYLERGONOVINE MALEATE	0.2MG/ML	INJECTABLE / INJECTION	AP		2008-11-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090193-001	METHYLERGONOVINE MALEATE	0.2MG/ML	INJECTABLE / INJECTION	AP		2008-11-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090193-001	METHYLERGONOVINE MALEATE	0.2MG/ML	INJECTABLE / INJECTION	AP		2008-11-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090193-001	METHYLERGONOVINE MALEATE	0.2MG/ML	INJECTABLE / INJECTION	AP		2008-11-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090193-001	METHYLERGONOVINE MALEATE	0.2MG/ML	INJECTABLE / INJECTION	AP		2008-11-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090193-001	METHYLERGONOVINE MALEATE	0.2MG/ML	INJECTABLE / INJECTION	AP		2008-11-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090193-001	METHYLERGONOVINE MALEATE	0.2MG/ML	INJECTABLE / INJECTION	AP		2008-11-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090193-001	METHYLERGONOVINE MALEATE	0.2MG/ML	INJECTABLE / INJECTION	AP		2008-11-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090193-001	METHYLERGONOVINE MALEATE	0.2MG/ML	INJECTABLE / INJECTION	AP		2008-11-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090193-001	METHYLERGONOVINE MALEATE	0.2MG/ML	INJECTABLE / INJECTION	AP		2008-11-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090193-001	METHYLERGONOVINE MALEATE	0.2MG/ML	INJECTABLE / INJECTION	AP		2008-11-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090193-001	METHYLERGONOVINE MALEATE	0.2MG/ML	INJECTABLE / INJECTION	AP		2008-11-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090193-001	METHYLERGONOVINE MALEATE	0.2MG/ML	INJECTABLE / INJECTION	AP		2008-11-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090193-001	METHYLERGONOVINE MALEATE	0.2MG/ML	INJECTABLE / INJECTION	AP		2008-11-24	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090193-001	METHYLERGONOVINE MALEATE	0.2MG/ML	INJECTABLE / INJECTION	AP		2008-11-24	`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	A090193-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090193-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090193-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090193-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090193-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090193-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090193-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090193-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090193-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090193-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090193-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090193-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090193-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090193-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090193-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090193-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090193-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090193-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090193-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090193-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090193-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090193-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090193-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090193-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090193-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090193-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090193-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090193-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090193-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090193-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090193-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090193-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090193-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090193-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090193-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090193-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090193-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090193-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090193-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090193-001	AP	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: METHYLERGONOVINE MALEATE
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
METHYLERGONOVINE MALEATE	.2 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
IR84JPZ1RK	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
996828	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4ddcdfff-1468-bff0-e063-6294a90a5480	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f8d59645-13e1-4381-94b1-6ca9c8d64fc8	Product name	5	20210615
12fc2a28-7c95-8272-24e2-ad0f6361d10b	Product name	2	20180723

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
51662-1668-1	METHYLERGONOVINE MALEATE	1 mL in 1 VIAL	INJECTION, SOLUTION	1		1

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
METHYLERGONOVINE MALEATE	METHYLERGONOVINE MALEATE	HF Acquisition Co. LLC. DBA HealthFirst	4ddcdfff-1468-bff0-e063-6294a90a5480	2026-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090193 application number: ANDA090193 ndc (product): 51662-1668
Methylergonovine Maleate	METHYLERGONOVINE MALEATE	American Regent, Inc.	a9a3079e-b62b-4858-920e-d8f5cb38481e	2026-03-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090193 application number: ANDA090193

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
996828	methylergonovine maleate 0.2 MG in 1 ML Injection	PSN	4ddcdfff-1468-bff0-e063-6294a90a5480	1
996828	1 ML methylergonovine maleate 0.2 MG/ML Injection	SCD	4ddcdfff-1468-bff0-e063-6294a90a5480	1
996828	methylergonovine maleate 0.2 MG per 1 ML Injection	SY	4ddcdfff-1468-bff0-e063-6294a90a5480	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
51662-1668-1	51662166801	1 mL in 1 VIAL (51662-1668-1)	1 ml	2010-06-21	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
METHYLERGONOVINE - HF Acquisition Co. LLC. DBA HealthFirst \| HF Acquisition Co LLC, DBA HealthFirst	HF Acquisition Co. LLC. DBA HealthFirst \| HF Acquisition Co LLC, DBA HealthFirst	2026-03-25	HUMAN PRESCRIPTION DRUG LABEL	1