Methotrexate

Product NDC: 60687-975
11-digit product format: 606870975
Labeler code: 60687
Product ID: 60687-975_5ccb5cac-e473-18b4-e063-6394a90ae16c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Methotrexate
Dosage form: TABLET
Route: ORAL
Labeler: American Health Packaging
Application: ANDA207812
Marketing category: ANDA
Marketing start: 2026-10-01
Substance: METHOTREXATE
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A207812-001	METHOTREXATE SODIUM	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB		2017-01-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207812-001	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 · 43 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
2026-09-14 22:38:34	2026-08	A207812-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2017-01-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207812-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2017-01-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207812-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2017-01-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207812-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2017-01-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207812-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2017-01-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207812-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2017-01-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207812-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2017-01-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207812-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2017-01-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207812-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2017-01-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207812-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2017-01-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207812-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2017-01-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207812-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2017-01-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207812-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2017-01-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207812-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2017-01-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207812-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2017-01-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207812-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2017-01-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207812-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2017-01-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207812-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2017-01-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207812-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2017-01-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207812-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2017-01-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207812-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2017-01-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207812-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2017-01-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207812-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2017-01-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207812-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2017-01-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207812-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2017-01-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207812-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2017-01-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207812-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2017-01-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207812-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2017-01-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207812-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2017-01-13	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207812-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2017-01-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207812-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2017-01-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207812-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2017-01-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207812-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2017-01-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207812-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2017-01-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207812-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2017-01-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207812-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2017-01-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207812-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2017-01-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207812-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2017-01-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207812-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2017-01-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207812-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2017-01-13	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A207812-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207812-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207812-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207812-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207812-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207812-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207812-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207812-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207812-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207812-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207812-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207812-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207812-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207812-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207812-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207812-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207812-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207812-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207812-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207812-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207812-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207812-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207812-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207812-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207812-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207812-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207812-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207812-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207812-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207812-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207812-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207812-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207812-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207812-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207812-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207812-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207812-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207812-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207812-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207812-001	AB	1	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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	Major Pharmaceuticals	2a6afc4c-819d-4ba9-8040-4504519c116a	2026-05-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207812 application number: ANDA207812
Methotrexate	METHOTREXATE	Zydus Pharmaceuticals USA Inc.	948e0bab-6524-4b87-9853-1799d4415558	2026-05-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207812 application number: ANDA207812
Methotrexate	METHOTREXATE	AvPAK	4992fdaa-b880-ee25-e063-6394a90af03b	2026-01-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207812 application number: ANDA207812
Methotrexate	METHOTREXATE	Zydus Lifesciences Limited	59ea7b32-2b6d-4197-92c3-015936f04ebe	2024-12-05		Exact identifier application applno (ANDA): 207812 application number: ANDA207812

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
YL5FZ2Y5U1	METHOTREXATE	59-05-2	METHOTREXATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
60687-975-94	60687097594	20 BLISTER PACK in 1 CARTON (60687-975-94) / 1 TABLET in 1 BLISTER PACK (60687-975-11)	20 blister pack	2026-10-01	No	No	Historical