Methotrexate

Product NDC: 0703-3678
11-digit product format: 007033678
Labeler code: 0703
Product ID: 0703-3678_e81074cc-12b4-4ac9-a5bb-749188989b2c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Methotrexate
Dosage form: INJECTION, SOLUTION
Route: INTRA-ARTERIAL; INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS
Labeler: Teva Parenteral Medicines, Inc.
Application: ANDA040843
Marketing category: ANDA
Marketing start: 2012-08-01
Substance: METHOTREXATE SODIUM
Active strength: 25 mg/mL
Pharmacologic classes: Folate Analog Metabolic Inhibitor [EPC], Folic Acid Metabolism Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0703-3678		D	Discontinued by firm	2026-08-17
excluded product	product	0703-3678		D	Discontinued by firm	2026-08-17
excluded package	package	0703-3678	0703-3678-01	D	Discontinued by firm	2026-08-17
excluded package	package	0703-3678	0703-3678-81	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 · 48 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 product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0703-3678-81	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0703-3678-01	`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 product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0703-3678-81	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0703-3678-01	`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 product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0703-3678-81	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0703-3678-01	`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 product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0703-3678-81	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0703-3678-01	`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 product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0703-3678-81	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0703-3678-01	`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 product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0703-3678-81	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0703-3678-01	`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 product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0703-3678-81	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0703-3678-01	`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 product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0703-3678-81	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0703-3678-01	`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 product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0703-3678-81	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0703-3678-01	`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 product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0703-3678-81	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0703-3678-01	`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 product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0703-3678-81	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0703-3678-01	`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 product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0703-3678-81	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0703-3678-01	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A040843-001	METHOTREXATE SODIUM PRESERVATIVE FREE	METHOTREXATE SODIUM	EQ 1GM BASE/40ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-01-11
A040843-002	METHOTREXATE SODIUM PRESERVATIVE FREE	METHOTREXATE SODIUM	EQ 50MG BASE/2ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-01-11
A040843-003	METHOTREXATE SODIUM PRESERVATIVE FREE	METHOTREXATE SODIUM	EQ 100MG BASE/4ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	2012-02-27
A040843-004	METHOTREXATE SODIUM PRESERVATIVE FREE	METHOTREXATE SODIUM	EQ 250MG BASE/10ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-01-11

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A040843-001	AP
A040843-002	AP
A040843-003	AP
A040843-004	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 5 · 168 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	A040843-001	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 1GM BASE/40ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-01-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040843-002	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 50MG BASE/2ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-01-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040843-003	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 100MG BASE/4ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	2012-02-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040843-004	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 250MG BASE/10ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-01-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040843-001	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 1GM BASE/40ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-01-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040843-002	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 50MG BASE/2ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-01-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040843-003	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 100MG BASE/4ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	2012-02-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040843-004	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 250MG BASE/10ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-01-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040843-001	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 1GM BASE/40ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-01-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040843-002	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 50MG BASE/2ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-01-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040843-003	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 100MG BASE/4ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	2012-02-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040843-004	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 250MG BASE/10ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-01-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040843-001	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 1GM BASE/40ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-01-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040843-002	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 50MG BASE/2ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-01-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040843-003	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 100MG BASE/4ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION		2012-02-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040843-004	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 250MG BASE/10ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-01-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040843-001	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 1GM BASE/40ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-01-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040843-002	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 50MG BASE/2ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-01-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040843-003	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 100MG BASE/4ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION		2012-02-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040843-004	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 250MG BASE/10ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-01-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040843-001	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 1GM BASE/40ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-01-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040843-002	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 50MG BASE/2ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-01-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040843-003	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 100MG BASE/4ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION		2012-02-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040843-004	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 250MG BASE/10ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-01-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040843-001	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 1GM BASE/40ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-01-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040843-002	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 50MG BASE/2ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-01-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040843-003	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 100MG BASE/4ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION		2012-02-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040843-004	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 250MG BASE/10ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-01-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040843-001	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 1GM BASE/40ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-01-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040843-002	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 50MG BASE/2ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-01-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040843-003	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 100MG BASE/4ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION		2012-02-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040843-004	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 250MG BASE/10ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-01-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040843-001	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 1GM BASE/40ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-01-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040843-002	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 50MG BASE/2ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-01-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040843-003	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 100MG BASE/4ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION		2012-02-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040843-004	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 250MG BASE/10ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-01-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040843-001	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 1GM BASE/40ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-01-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040843-002	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 50MG BASE/2ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-01-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040843-003	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 100MG BASE/4ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION		2012-02-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040843-004	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 250MG BASE/10ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	2010-01-11	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 134 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	A040843-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040843-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040843-003	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040843-004	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040843-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040843-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040843-003	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040843-004	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040843-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040843-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040843-003	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040843-004	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040843-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040843-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040843-004	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040843-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040843-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040843-004	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040843-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040843-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040843-004	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040843-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040843-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040843-004	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040843-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040843-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040843-004	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040843-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040843-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040843-004	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040843-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040843-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040843-004	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040843-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040843-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040843-004	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040843-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040843-002	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040843-004	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040843-001	AP	1	`301d65b070ca…`

Additional Listing Data#

Finished product: Yes
Brand name base: Methotrexate
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
METHOTREXATE SODIUM	25 mg/mL

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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1655956	Internal RxNorm lookup
1655959	Internal RxNorm lookup
1655960	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
346ec9ce-dc98-4a55-b55e-d3af11f2d703	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0703-3678-01	Methotrexate	1 in 1 CARTON	INJECTION, SOLUTION	1		11
0703-3678-01	Methotrexate	40 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	40		11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0703-3678-01	ML - Milliliter	0703-3678	d8252b99-4af7-4a3b-b7ea-eee01aa6a767	1	2013-02-13
0703-3678-81	ML - Milliliter	0703-3678	352c9a03-bc3e-4cea-b363-d22508599454	1	2016-01-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
METHOTREXATE SODIUM	ACTIVE INGREDIENT	3IG1E710ZN	METHOTREXATE (METHOTREXATE SODIUM) INJECTION, SOLUTION [TEVA PARENTERAL MEDICINES, INC.]	2
METHOTREXATE	ACTIVE MOIETY	YL5FZ2Y5U1	METHOTREXATE (METHOTREXATE SODIUM) INJECTION, SOLUTION [TEVA PARENTERAL MEDICINES, INC.]	2
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	METHOTREXATE (METHOTREXATE SODIUM) INJECTION, SOLUTION [TEVA PARENTERAL MEDICINES, INC.]	2
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	METHOTREXATE (METHOTREXATE SODIUM) INJECTION, SOLUTION [TEVA PARENTERAL MEDICINES, INC.]	2
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	METHOTREXATE (METHOTREXATE SODIUM) INJECTION, SOLUTION [TEVA PARENTERAL MEDICINES, INC.]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	METHOTREXATE (METHOTREXATE SODIUM) INJECTION, SOLUTION [TEVA PARENTERAL MEDICINES, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0703-3678	METHOTREXATE INJECTION, SOLUTION [TEVA PARENTERAL MEDICINES, INC.]	10	Current NDC, Legacy NDC, 2 package rows	20240616_346ec9ce-dc98-4a55-b55e-d3af11f2d703.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	METHOTREXATE	Teva Parenteral Medicines, Inc.	346ec9ce-dc98-4a55-b55e-d3af11f2d703	2025-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040843 application number: ANDA040843 ndc (product): 0703-3678

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
1655956	methotrexate 1 GM in 40 ML Injection	PSN	346ec9ce-dc98-4a55-b55e-d3af11f2d703	11
1655959	methotrexate 250 MG in 10 ML Injection	PSN	346ec9ce-dc98-4a55-b55e-d3af11f2d703	11
1655960	methotrexate 50 MG in 2 ML Injection	PSN	346ec9ce-dc98-4a55-b55e-d3af11f2d703	11
1655959	10 ML methotrexate 25 MG/ML Injection	SCD	346ec9ce-dc98-4a55-b55e-d3af11f2d703	11
1655960	2 ML methotrexate 25 MG/ML Injection	SCD	346ec9ce-dc98-4a55-b55e-d3af11f2d703	11
1655956	40 ML methotrexate 25 MG/ML Injection	SCD	346ec9ce-dc98-4a55-b55e-d3af11f2d703	11
1655956	methotrexate 1 GM per 40 ML Injection	SY	346ec9ce-dc98-4a55-b55e-d3af11f2d703	11
1655959	methotrexate 250 MG per 10 ML Injection	SY	346ec9ce-dc98-4a55-b55e-d3af11f2d703	11
1655960	methotrexate 50 MG per 2 ML Injection	SY	346ec9ce-dc98-4a55-b55e-d3af11f2d703	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0703-3678-01	00703367801	1 VIAL, SINGLE-DOSE in 1 CARTON (0703-3678-01) / 40 mL in 1 VIAL, SINGLE-DOSE	2012-08-01	0000-00-00	No	No	Current
0703-3678-81	00703367881	1 VIAL, SINGLE-DOSE in 1 CARTON (0703-3678-81) > 40 mL in 1 VIAL, SINGLE-DOSE	2015-12-14	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Methotrexate	Teva Parenteral Medicines, Inc.	2025-07-15	HUMAN PRESCRIPTION DRUG LABEL	11
Methotrexate	Teva Parenteral Medicines, Inc.	2021-06-30	HUMAN PRESCRIPTION DRUG LABEL	10