Methylergonovine Maleate

Product NDC: 43386-140
11-digit product format: 433860140
Labeler code: 43386
Product ID: 43386-140_16ee131d-1b49-4b13-9e23-e915401e7093
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Methylergonovine Maleate
Dosage form: TABLET
Route: ORAL
Labeler: Lupin Pharmaceuticals,Inc.
Application: ANDA091577
Marketing category: ANDA
Marketing start: 2011-06-15
Marketing end: 0000-00-00
Substance: METHYLERGONOVINE MALEATE
Active strength: 0 mg/1
Pharmacologic classes: Ergolines [CS],Ergot Derivative [EPC]
NDC exclude flag: No
Listing certified through: 2020-12-31
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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	43386-140		I	Inactivated by FDA	2026-08-11
excluded package	package	43386-140	43386-140-01	I	Inactivated by FDA	2026-08-11
excluded package	package	43386-140	43386-140-07	I	Inactivated by FDA	2026-08-11
excluded package	package	43386-140	43386-140-12	I	Inactivated by FDA	2026-08-11
excluded package	package	43386-140	43386-140-28	I	Inactivated by FDA	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 2 · 75 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43386-140-12	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43386-140-07	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43386-140-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43386-140-28	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43386-140-12	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43386-140-07	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43386-140-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43386-140-28	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43386-140-12	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43386-140-07	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43386-140-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43386-140-28	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43386-140-12	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43386-140-07	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43386-140-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43386-140-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43386-140-12	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43386-140-07	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43386-140-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43386-140-28	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43386-140-12	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43386-140-07	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43386-140-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43386-140-28	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43386-140-12	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43386-140-07	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43386-140-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43386-140-28	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43386-140-12	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43386-140-07	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43386-140-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43386-140-28	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	43386-140-12	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	43386-140-07	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	43386-140-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	43386-140-28	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	43386-140-12	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	43386-140-07	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	43386-140-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	43386-140-28	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	43386-140-12	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	43386-140-07	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	43386-140-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	43386-140-28	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	43386-140-12	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	43386-140-07	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	43386-140-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	43386-140-28	`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
A091577-001	METHYLERGONOVINE MALEATE	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	RS	2011-05-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091577-001	AB

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	A091577-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	RS	2011-05-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091577-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	RS	2011-05-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091577-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	RS	2011-05-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091577-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	RS	2011-05-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091577-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	RS	2011-05-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091577-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	RS	2011-05-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091577-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	RS	2011-05-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091577-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	RS	2011-05-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091577-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	RS	2011-05-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091577-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	RS	2011-05-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091577-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	RS	2011-05-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091577-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	RS	2011-05-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091577-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	RS	2011-05-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091577-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	RS	2011-05-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091577-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	RS	2011-05-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091577-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	RS	2011-05-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091577-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	RS	2011-05-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091577-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	RS	2011-05-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091577-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	RS	2011-05-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091577-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	RS	2011-05-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091577-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	RS	2011-05-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091577-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	RS	2011-05-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091577-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	RS	2011-05-02	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091577-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	RS	2011-05-02	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091577-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	RS	2011-05-02	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091577-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	RS	2011-05-02	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091577-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	RS	2011-05-02	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091577-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	RS	2011-05-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091577-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	RS	2011-05-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091577-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	RS	2011-05-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091577-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	RS	2011-05-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091577-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	RS	2011-05-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091577-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	RS	2011-05-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091577-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	RS	2011-05-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091577-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	RS	2011-05-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091577-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	RS	2011-05-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091577-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	RS	2011-05-02	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091577-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	RS	2011-05-02	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091577-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	RS	2011-05-02	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091577-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	RS	2011-05-02	`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	A091577-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091577-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091577-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091577-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091577-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091577-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091577-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091577-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091577-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091577-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091577-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091577-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091577-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091577-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091577-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091577-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091577-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091577-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091577-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091577-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091577-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091577-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091577-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091577-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091577-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091577-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091577-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091577-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091577-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091577-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091577-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091577-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091577-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091577-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091577-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091577-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091577-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091577-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091577-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091577-001	AB	1	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f8d59645-13e1-4381-94b1-6ca9c8d64fc8	Product name	5	20210615
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
12fc2a28-7c95-8272-24e2-ad0f6361d10b	Product name	2	20180723

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
43386-140-01	Methylergonovine Maleate Tablets, USP
43386-140-07	Methylergonovine Maleate Tablets, USP
43386-140-12	Methylergonovine Maleate Tablets, USP
43386-140-28	Methylergonovine Maleate Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
43386-140-01	Methylergonovine Maleate	100 in 1 BOTTLE	TABLET	100	3
43386-140-07	Methylergonovine Maleate	7 in 1 BOTTLE	TABLET	7	3
43386-140-12	Methylergonovine Maleate	12 in 1 BOTTLE	TABLET	12	3
43386-140-28	Methylergonovine Maleate	28 in 1 BOTTLE	TABLET	28	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43386-140-01	EA - Each	43386-140	a8fab3eb-9f89-4eb3-ab64-782e6dad6c55	1	2012-07-24
43386-140-07	EA - Each	43386-140	f67746cb-906a-4a77-9dc1-e2fe62d6172e	1	2013-11-04
43386-140-12	EA - Each	43386-140	5568ee02-0d98-4c52-a4bf-ea1c70fdff95	1	2018-06-11
43386-140-28	EA - Each	43386-140	ad84f625-c4a4-4c93-a4cb-03128f0820ae	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 TABLET [GAVIS PHARMACEUTICALS, LLC]	2
METHYLERGONOVINE	ACTIVE MOIETY	W53L6FE61V	METHYLERGONOVINE MALEATE TABLET [GAVIS PHARMACEUTICALS, LLC]	2
ACACIA	INACTIVE INGREDIENT	5C5403N26O	METHYLERGONOVINE MALEATE TABLET [GAVIS PHARMACEUTICALS, LLC]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	METHYLERGONOVINE MALEATE TABLET [GAVIS PHARMACEUTICALS, LLC]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	METHYLERGONOVINE MALEATE TABLET [GAVIS PHARMACEUTICALS, LLC]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	METHYLERGONOVINE MALEATE TABLET [GAVIS PHARMACEUTICALS, LLC]	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	METHYLERGONOVINE MALEATE TABLET [GAVIS PHARMACEUTICALS, LLC]	2
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	METHYLERGONOVINE MALEATE TABLET [GAVIS PHARMACEUTICALS, LLC]	2
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	METHYLERGONOVINE MALEATE TABLET [GAVIS PHARMACEUTICALS, LLC]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	METHYLERGONOVINE MALEATE TABLET [GAVIS PHARMACEUTICALS, LLC]	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	METHYLERGONOVINE MALEATE TABLET [GAVIS PHARMACEUTICALS, LLC]	2
TARTARIC ACID	INACTIVE INGREDIENT	W4888I119H	METHYLERGONOVINE MALEATE TABLET [GAVIS PHARMACEUTICALS, LLC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43386-140	METHYLERGONOVINE MALEATE TABLET [LUPIN PHARMACEUTICALS,INC.]	3	Legacy NDC, 4 package rows	20171117_f617b954-71b9-4bef-aeb2-f87eb9f04ef6.zip

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Methergine	METHYLERGONOVINE MALEATE	Lupin Pharmaceuticals,Inc.	3f04ca06-fe52-46d6-96cd-2e77ef6fa36f	2024-03-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091577 application number: ANDA091577

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
996824	methylergonovine maleate 0.2 MG Oral Tablet	PSN	f617b954-71b9-4bef-aeb2-f87eb9f04ef6	3
996824	methylergonovine maleate 0.2 MG Oral Tablet	SCD	f617b954-71b9-4bef-aeb2-f87eb9f04ef6	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
43386-140-01	43386014001	100 TABLET in 1 BOTTLE (43386-140-01)	100 tablet	2011-06-15	0000-00-00	No	No	Current
43386-140-07	43386014007	7 TABLET in 1 BOTTLE (43386-140-07)	7 tablet	2011-06-15	0000-00-00	No	No	Current
43386-140-12	43386014012	12 TABLET in 1 BOTTLE (43386-140-12)	12 tablet	2017-11-10	0000-00-00	No	No	Current
43386-140-28	43386014028	28 TABLET in 1 BOTTLE (43386-140-28)	28 tablet	2011-06-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Methylergonovine Maleate Tablets, USP Rx Only	AvPAK	2021-01-05	HUMAN PRESCRIPTION DRUG LABEL	1
Methylergonovine Maleate Tablets, USP	Lupin Pharmaceuticals,Inc. \| Novel Laboratories, Inc.	2017-11-13	HUMAN PRESCRIPTION DRUG LABEL	3