Methotrexate Sodium

Product NDC: 0054-8550
11-digit product format: 000548550
Labeler code: 0054
Product ID: 0054-8550_d72fc36a-3aee-493b-9fa1-5ce69d35b39d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Methotrexate Sodium
Dosage form: TABLET
Route: ORAL
Labeler: West-Ward Pharmaceuticals Corp.
Application: ANDA040054
Marketing category: ANDA
Marketing start: 1994-08-01
Marketing end: 0000-00-00
Substance: METHOTREXATE SODIUM
Active strength: 3 mg/1
Pharmacologic classes: Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA]
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0054-8550		D	Discontinued by firm		2026-08-17
excluded package	package	0054-8550	0054-8550-25	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 · 12 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	0054-8550-25	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0054-8550-25	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0054-8550-25	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0054-8550-25	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0054-8550-25	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0054-8550-25	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0054-8550-25	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0054-8550-25	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0054-8550-25	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0054-8550-25	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0054-8550-25	`367a005e9d99…`	`383a685ebd0f…`

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
A040054-001	METHOTREXATE SODIUM	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	RS	1994-08-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040054-001	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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A040054-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	RS	1994-08-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040054-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	RS	1994-08-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040054-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	RS	1994-08-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040054-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	RS	1994-08-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040054-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	RS	1994-08-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040054-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	RS	1994-08-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040054-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	RS	1994-08-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040054-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	RS	1994-08-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040054-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	RS	1994-08-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040054-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	RS	1994-08-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040054-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	RS	1994-08-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040054-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	RS	1994-08-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040054-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	RS	1994-08-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040054-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	RS	1994-08-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040054-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	RS	1994-08-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040054-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	RS	1994-08-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040054-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	RS	1994-08-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040054-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	RS	1994-08-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040054-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB		1994-08-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040054-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	RS	1994-08-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040054-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	RS	1994-08-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040054-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	RS	1994-08-01	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040054-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	RS	1994-08-01	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040054-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	RS	1994-08-01	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040054-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	RS	1994-08-01	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040054-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB		1994-08-01	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040054-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB		1994-08-01	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040054-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB		1994-08-01	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040054-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	RS	1994-08-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040054-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	RS	1994-08-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040054-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	RS	1994-08-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040054-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	RS	1994-08-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040054-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	RS	1994-08-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040054-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	RS	1994-08-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040054-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	RS	1994-08-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040054-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	RS	1994-08-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040054-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	RS	1994-08-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040054-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	RS	1994-08-01	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040054-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	RS	1994-08-01	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040054-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	RS	1994-08-01	`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	A040054-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040054-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040054-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040054-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040054-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040054-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040054-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040054-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040054-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040054-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040054-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040054-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040054-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040054-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040054-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040054-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040054-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040054-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040054-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040054-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040054-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040054-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040054-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040054-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040054-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040054-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040054-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040054-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040054-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040054-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040054-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040054-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040054-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040054-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040054-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040054-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040054-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040054-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040054-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040054-001	AB	1	`e64feba35796…`

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0054-8550-25	Methotrexate Sodium	10 in 1 CARTON	TABLET	10		20
0054-8550-25	Methotrexate Sodium	10 in 1 BLISTER PACK	TABLET	10		20

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0054-8550-25	EA - Each	0054-8550	9e42898c-b06c-4d0a-b493-675535405ad9	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
METHOTREXATE SODIUM	ACTIVE INGREDIENT	3IG1E710ZN	METHOTREXATE SODIUM TABLET [ROXANE LABORATORIES, INC]	8
METHOTREXATE	ACTIVE MOIETY	YL5FZ2Y5U1	METHOTREXATE SODIUM TABLET [ROXANE LABORATORIES, INC]	8
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	METHOTREXATE SODIUM TABLET [ROXANE LABORATORIES, INC]	8
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	METHOTREXATE SODIUM TABLET [ROXANE LABORATORIES, INC]	8
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	METHOTREXATE SODIUM TABLET [ROXANE LABORATORIES, INC]	8
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	METHOTREXATE SODIUM TABLET [ROXANE LABORATORIES, INC]	8
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	METHOTREXATE SODIUM TABLET [ROXANE LABORATORIES, INC]	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0054-8550	METHOTREXATE SODIUM TABLET [HIKMA PHARMACEUTICALS USA INC.]	17	Legacy NDC, 2 package rows	20240302_d71b1856-99d8-4a9e-9189-f87b6675f80a.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
Methotrexate Sodium	METHOTREXATE SODIUM	Hikma Pharmaceuticals USA Inc.	d71b1856-99d8-4a9e-9189-f87b6675f80a	2026-05-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040054 application number: ANDA040054 ndc (product): 0054-8550

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
3IG1E710ZN	METHOTREXATE SODIUM	7413-34-5	METHOTREXATE SODIUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
105585	methotrexate 2.5 MG Oral Tablet	PSN	d71b1856-99d8-4a9e-9189-f87b6675f80a	20
105585	methotrexate 2.5 MG Oral Tablet	SCD	d71b1856-99d8-4a9e-9189-f87b6675f80a	20
105585	methotrexate 2.5 MG (as methotrexate sodium) Oral Tablet	SY	d71b1856-99d8-4a9e-9189-f87b6675f80a	20

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0054-8550-25	00054855025	10 BLISTER PACK in 1 CARTON (0054-8550-25) > 10 TABLET in 1 BLISTER PACK	10 blister pack	1994-08-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Methotrexate Sodium	Hikma Pharmaceuticals USA Inc. \| West-Ward Columbus Inc.	2026-05-20	HUMAN PRESCRIPTION DRUG LABEL	20