Methylergonovine Maleate

Product NDC: 17856-3655
Requested package NDC: 17856-3655-1
11-digit product format: 178563655
Labeler code: 17856
Product ID: 17856-3655_9c950e09-52c8-482e-b642-2b11b00116d5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Methylergonovine Maleate
Dosage form: TABLET
Route: ORAL
Labeler: ATLANTIC BIOLOGICALS CORP.
Application: ANDA211455
Marketing category: ANDA
Marketing start: 2019-03-26
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: 2021-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	17856-3655	17856-3655-1	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 1 · 18 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…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	`bd6a592717d7…`	`303034d00443…`

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
A211455-001	METHYLERGONOVINE MALEATE	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB		2019-03-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211455-001	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A211455-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	2019-03-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211455-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	2019-03-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211455-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	2019-03-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211455-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	2019-03-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211455-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	2019-03-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211455-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	2019-03-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211455-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	2019-03-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211455-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	2019-03-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211455-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	2019-03-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211455-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	2019-03-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211455-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	2019-03-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211455-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	2019-03-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211455-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	2019-03-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211455-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	2019-03-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211455-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	2019-03-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211455-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	2019-03-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211455-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	2019-03-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211455-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	2019-03-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211455-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	2019-03-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211455-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	2019-03-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211455-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	2019-03-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211455-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	2019-03-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211455-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	2019-03-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211455-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	2019-03-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211455-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	2019-03-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211455-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	2019-03-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A211455-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	2019-03-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211455-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	2019-03-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211455-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	2019-03-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211455-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	2019-03-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211455-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	2019-03-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211455-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	2019-03-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211455-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	2019-03-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211455-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	2019-03-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211455-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	2019-03-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211455-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	2019-03-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211455-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	2019-03-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211455-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	2019-03-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211455-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	2019-03-20	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211455-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	2019-03-20	`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	A211455-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211455-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211455-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211455-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211455-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211455-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211455-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211455-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211455-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211455-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211455-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211455-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211455-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211455-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211455-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211455-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211455-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211455-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211455-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211455-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211455-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211455-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211455-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211455-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211455-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211455-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A211455-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211455-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211455-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211455-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211455-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211455-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211455-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211455-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211455-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211455-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211455-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211455-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211455-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211455-001	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, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
17856-3655-1	2022-01-28	C162847	48780-1	d6a99b39-5280-a426-e053-dadaa90af4c2	Methylergonovine Maleate Tablets USP A211455

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
17856-3655-1	Methylergonovine Maleate	100 in 1 BOX, UNIT-DOSE	TABLET	100		1
17856-3655-1	Methylergonovine Maleate	1 in 1 POUCH	TABLET	1		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
17856-3655	METHYLERGONOVINE MALEATE TABLET [ATLANTIC BIOLOGICALS CORP.]	1	Legacy NDC, 2 package rows	20200201_2fbdc9c4-b9d4-4796-adda-6144bdea0990.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
Methylergonovine Maleate	METHYLERGONOVINE MALEATE	Teva Pharmaceuticals USA, Inc.	d8e4b8ed-3289-4611-8a61-2392a4bf6072	2026-05-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211455 application number: ANDA211455

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	2fbdc9c4-b9d4-4796-adda-6144bdea0990	1
996824	methylergonovine maleate 0.2 MG Oral Tablet	SCD	2fbdc9c4-b9d4-4796-adda-6144bdea0990	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
17856-3655-1	17856365501	100 POUCH in 1 BOX, UNIT-DOSE (17856-3655-1) > 1 TABLET in 1 POUCH	100 pouch	2020-01-31	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Methylergonovine Maleate Tablets USP A211455	ATLANTIC BIOLOGICALS CORP.	2020-01-31	HUMAN PRESCRIPTION DRUG LABEL	1