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…`

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

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 · 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

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