Methotrexate tablet, USP

Manufacturer: Zydus Lifesciences Limited | Zydus Pharmaceuticals USA Inc.
Effective date: 2024-12-05
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 8
Source: full-release
Hydrated at: 2026-05-31 21:18:50

Label at a glance#

ProductMethotrexate

Active ingredientMETHOTREXATE

Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SPL UNCLASSIFIED SECTION

NDC 70771-1058-1

Methotrexate tablets, USP 2.5 mg

Rx only

36 tablets

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
105585	methotrexate 2.5 MG Oral Tablet	PSN	8
105585	methotrexate 2.5 MG Oral Tablet	SCD	8
105585	methotrexate 2.5 MG (as methotrexate sodium) Oral Tablet	SY	8

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
METHOTREXATE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

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	SPL version
70771-1058-0	Methotrexate	1000 in 1 BOTTLE	TABLET	1000	8
70771-1058-1	Methotrexate	100 in 1 BOTTLE	TABLET	100	8
70771-1058-2	Methotrexate	1 in 1 BLISTER PACK	TABLET	1	8
70771-1058-3	Methotrexate	36 in 1 BOTTLE	TABLET	36	8
70771-1058-5	Methotrexate	500 in 1 BOTTLE	TABLET	500	8
70771-1058-7	Methotrexate	100 in 1 CARTON	TABLET	100	8
70771-1058-9	Methotrexate	90 in 1 BOTTLE	TABLET	90	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70771-1058	METHOTREXATE TABLET [ZYDUS LIFESCIENCES LIMITED]	8	Current NDC, Legacy NDC, 7 package rows	20241207_59ea7b32-2b6d-4197-92c3-015936f04ebe.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

Methotrexate
ANHYDROUS LACTOSE
CELLULOSE, MICROCRYSTALLINE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
STARCH, CORN

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
70771-1058	70771-1058-3, 70771-1058-9, 70771-1058-1, 70771-1058-5, 70771-1058-0, 70771-1058-2, 70771-1058-7

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
METHOTREXATE	YL5FZ2Y5U1	ACTIB
ANHYDROUS LACTOSE	3SY5LH9PMK	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
STARCH, CORN	O8232NY3SJ	IACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

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…`

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	Zydus Lifesciences Limited	59ea7b32-2b6d-4197-92c3-015936f04ebe	2024-12-05		Exact identifier ndc (package): 70771-1058-9 ndc (package): 70771-1058-5 ndc (package): 70771-1058-1 ndc (package): 70771-1058-3 ndc (package): 70771-1058-7 ndc (package): 70771-1058-0 ndc (package): 70771-1058-2 ndc (product): 70771-1058 ndc11 (package): 70771105801 ndc11 (package): 70771105809 ndc11 (package): 70771105803 ndc11 (package): 70771105805 ndc11 (package): 70771105807 ndc11 (package): 70771105800 ndc11 (package): 70771105802 spl id: ae399908-cfb6-44dc-83da-8981f5dabbb8 spl set id: 59ea7b32-2b6d-4197-92c3-015936f04ebe

Reported adverse events (FAERS/openFDA)#

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