Methotrexate

Product NDC: 48433-065
Requested package NDC: 48433-065-05
11-digit product format: 484330065
Labeler code: 48433
Product ID: 48433-065_49a1fdee-5587-e05a-e063-6294a90aebc5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: methotrexate
Dosage form: TABLET
Route: ORAL
Labeler: Safecor Health LLC
Application: ANDA081235
Marketing category: ANDA
Marketing start: 2026-01-19
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A081235-001	METHOTREXATE SODIUM	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB		1992-05-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A081235-001	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 · 41 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
2026-02-19 14:30 UTC	2026-02	A081235-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1992-05-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A081235-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1992-05-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A081235-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1992-05-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A081235-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1992-05-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A081235-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1992-05-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A081235-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1992-05-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A081235-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1992-05-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A081235-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1992-05-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A081235-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1992-05-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A081235-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1992-05-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A081235-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1992-05-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A081235-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1992-05-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A081235-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1992-05-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A081235-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1992-05-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A081235-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1992-05-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A081235-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1992-05-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A081235-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1992-05-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A081235-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1992-05-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A081235-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1992-05-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A081235-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1992-05-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A081235-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1992-05-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A081235-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1992-05-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A081235-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1992-05-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A081235-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1992-05-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A081235-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1992-05-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A081235-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1992-05-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A081235-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1992-05-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A081235-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1992-05-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A081235-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1992-05-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A081235-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1992-05-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A081235-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1992-05-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A081235-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1992-05-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A081235-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1992-05-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A081235-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1992-05-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A081235-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1992-05-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A081235-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1992-05-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A081235-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1992-05-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A081235-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1992-05-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A081235-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1992-05-15	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A081235-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1992-05-15	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A081235-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A081235-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A081235-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A081235-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A081235-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A081235-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A081235-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A081235-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A081235-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A081235-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A081235-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A081235-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A081235-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A081235-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A081235-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A081235-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A081235-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A081235-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A081235-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A081235-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A081235-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A081235-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A081235-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A081235-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A081235-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A081235-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A081235-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A081235-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A081235-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A081235-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A081235-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A081235-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A081235-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A081235-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A081235-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A081235-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A081235-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A081235-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A081235-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A081235-001	AB	1	`cb3db0bc1861…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Methotrexate	METHOTREXATE	Bryant Ranch Prepack	0b54b5c4-2466-4f85-b9a0-ad93ec4a06a1	2026-06-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 081235 application number: ANDA081235
Methotrexate	METHOTREXATE	Mylan Pharmaceuticals Inc.	70c09984-2b36-424f-8b27-3fd0cd4e833d	2026-05-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 081235 application number: ANDA081235
Methotrexate	METHOTREXATE	Golden State Medical Supply, Inc.	6f14ced9-c16b-905a-e053-2a91aa0a031e	2026-04-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 081235 application number: ANDA081235
Methotrexate	METHOTREXATE	Safecor Health LLC	f177e6fa-c482-432d-8208-937468ab3f10	2026-01-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 081235 application number: ANDA081235 ndc (package): 48433-065-05 ndc (product): 48433-065 ndc11 (package): 48433006505
Methotrexate	METHOTREXATE	Mylan Institutional Inc.	8df0780e-0fbd-4ab8-80b0-7a5eaa08ec0a	2025-07-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 081235 application number: ANDA081235

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
f177e6fa-c482-432d-8208-937468ab3f10	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
48433-065-01	Methotrexate	1 in 1 BLISTER PACK	TABLET	1		2
48433-065-05	Methotrexate	20 in 1 CARTON	TABLET	20		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
48433-065-05	EA - Each	48433-065	9323610b-703d-4b26-aa83-8eaef0922050	1	2026-05-22

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	f177e6fa-c482-432d-8208-937468ab3f10	2
105585	methotrexate 2.5 MG Oral Tablet	SCD	f177e6fa-c482-432d-8208-937468ab3f10	2
105585	methotrexate 2.5 MG (as methotrexate sodium) Oral Tablet	SY	f177e6fa-c482-432d-8208-937468ab3f10	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
48433-065-05	48433006505	20 BLISTER PACK in 1 CARTON (48433-065-05) / 1 TABLET in 1 BLISTER PACK (48433-065-01)	20 blister pack	2026-01-19	No	No	Current