Methotrexate

Product NDC: 50090-5457
Requested package NDC: 50090-5457-2
11-digit product format: 500905457
Labeler code: 50090
Product ID: 50090-5457_9a056178-22ac-4049-87ac-226d306eea2d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Methotrexate
Dosage form: TABLET
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA081099
Marketing category: ANDA
Marketing start: 1990-11-01
Substance: METHOTREXATE SODIUM
Active strength: 2.5 mg/1
Pharmacologic classes: Folate Analog Metabolic Inhibitor [EPC], Folic Acid Metabolism Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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	50090-5457	50090-5457-2	D	Discontinued by firm		2026-08-17

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50090-5457	50090-5457-2	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50090-5457	50090-5457-2	D	Discontinued by firm		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A081099-001	METHOTREXATE SODIUM	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB		1990-10-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A081099-001	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 · 42 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
2026-08-18 06:07:40	2026-07	A081099-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1990-10-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A081099-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1990-10-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A081099-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1990-10-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A081099-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1990-10-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A081099-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1990-10-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A081099-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1990-10-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A081099-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1990-10-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A081099-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1990-10-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A081099-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1990-10-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A081099-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1990-10-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A081099-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1990-10-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A081099-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1990-10-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A081099-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1990-10-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A081099-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1990-10-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A081099-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1990-10-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A081099-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1990-10-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A081099-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1990-10-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A081099-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1990-10-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A081099-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1990-10-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A081099-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1990-10-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A081099-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1990-10-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A081099-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1990-10-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A081099-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1990-10-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A081099-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1990-10-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A081099-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1990-10-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A081099-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1990-10-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A081099-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1990-10-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A081099-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1990-10-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A081099-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1990-10-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A081099-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1990-10-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A081099-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1990-10-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A081099-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1990-10-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A081099-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1990-10-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A081099-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1990-10-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A081099-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1990-10-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A081099-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1990-10-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A081099-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1990-10-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A081099-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1990-10-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A081099-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1990-10-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A081099-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1990-10-15	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A081099-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A081099-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A081099-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A081099-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A081099-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A081099-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A081099-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A081099-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A081099-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A081099-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A081099-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A081099-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A081099-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A081099-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A081099-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A081099-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A081099-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A081099-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A081099-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A081099-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A081099-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A081099-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A081099-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A081099-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A081099-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A081099-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A081099-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A081099-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A081099-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A081099-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A081099-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A081099-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A081099-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A081099-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A081099-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A081099-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A081099-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A081099-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A081099-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A081099-001	AB	1	`e64feba35796…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
METHOTREXATE SODIUM	2.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
3IG1E710ZN	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
105585	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
22e10810-16fb-4c84-bccf-972405b77ef8	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
2eb9a854-4fbc-9bbe-3199-41fc1018a1f0	Product name	9	20250224
3082de91-569a-4d57-b379-acbf37f1d5c3	Product name	1	20210312
f76135bc-a210-42d9-851b-1b73cbaccdb3	Product name	1	20200511
423544b2-e325-49ee-8910-4c5dfe41906f	Product name	1	20181120
c9fd924b-0a8d-4d53-bf70-11070e24e4dd	Product name	2	20181120
ce1e7cc6-4850-4cb1-8dde-8010b2fbc359	Product name	1	20181120
eb454f54-2806-4c31-a08b-8dcb08261099	Product name	2	20181120
d9cebc09-c68d-46f5-bdcd-fd82e945cc27	Product name	1	20170705
16ba0c1e-2371-48a4-8b4c-a9a338dfe1f3	Product name	2	20160504
88514aea-9d58-4ed2-b135-9811fb14c8fb	Product name	1	20141209
0eba90a2-1cca-7e7b-28a5-85a09e2bc9a4	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
50090-5457-2	2023-02-07	These highlights do not include all the information needed to use METHOTREXATE TABLETS safely and effectively. See full prescribing information for METHOTREXATE TABLETS. METHOTREXATE tablets, for oral use Initial U.S. Approval: 1953
50090-5457-9	2023-02-07	These highlights do not include all the information needed to use METHOTREXATE TABLETS safely and effectively. See full prescribing information for METHOTREXATE TABLETS. METHOTREXATE tablets, for oral use Initial U.S. Approval: 1953
50090-5457-2	2023-01-30	These highlights do not include all the information needed to use METHOTREXATE TABLETS safely and effectively. See full prescribing information for METHOTREXATE TABLETS. METHOTREXATE tablets, for oral use Initial U.S. Approval: 1953
50090-5457-9	2023-01-30	These highlights do not include all the information needed to use METHOTREXATE TABLETS safely and effectively. See full prescribing information for METHOTREXATE TABLETS. METHOTREXATE tablets, for oral use Initial U.S. Approval: 1953

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-5457-2	Methotrexate	100 in 1 BOTTLE	TABLET	100		15
50090-5457-9	Methotrexate	36 in 1 BOTTLE	TABLET	36		15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-5457-9	EA - Each	50090-5457	0a82e7d0-7b22-45a2-bfed-d3f843c351b6	1	2024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-5457	METHOTREXATE TABLET [A-S MEDICATION SOLUTIONS]	10	Current NDC, Legacy NDC, 2 package rows	20240604_22e10810-16fb-4c84-bccf-972405b77ef8.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Methotrexate	METHOTREXATE	AvKARE	757d6cef-6696-7a1c-8074-01258aaa8bdd	2026-07-23	Boxed warning, Adverse reactions	Exact identifier application applno (ANDA): 081099 application number: ANDA081099
Methotrexate	METHOTREXATE	Teva Pharmaceuticals USA, Inc.	9b34b1d8-d125-41a2-9f6f-3fab67b573bd	2026-06-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 081099 application number: ANDA081099
Methotrexate	METHOTREXATE	A-S Medication Solutions	22e10810-16fb-4c84-bccf-972405b77ef8	2026-02-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 081099 application number: ANDA081099 ndc (package): 50090-5457-2 ndc (product): 50090-5457 ndc11 (package): 50090545702
Methotrexate	METHOTREXATE	Bryant Ranch Prepack	e6611304-4622-4b2e-9b94-57fbad023ae2	2024-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 081099 application number: ANDA081099

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
3IG1E710ZN	METHOTREXATE SODIUM	7413-34-5	METHOTREXATE SODIUM
YL5FZ2Y5U1	METHOTREXATE	59-05-2	Methotrexate

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
105585	methotrexate 2.5 MG Oral Tablet	PSN	22e10810-16fb-4c84-bccf-972405b77ef8	15
105585	methotrexate 2.5 MG Oral Tablet	SCD	22e10810-16fb-4c84-bccf-972405b77ef8	15
105585	methotrexate 2.5 MG (as methotrexate sodium) Oral Tablet	SY	22e10810-16fb-4c84-bccf-972405b77ef8	15

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-5457-2	50090545702	100 TABLET in 1 BOTTLE (50090-5457-2)	100 tablet	2021-01-29	0000-00-00	No	No	Current