Application 081235

Type: ANDA
Sponsor: MYLAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	METHOTREXATE SODIUM	METHOTREXATE SODIUM	TABLET;ORAL	EQ 2.5MG BASE	No	No

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

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 · 42 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	A081235-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1992-05-15	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 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	A081235-001	AB	1	`caaa826d4ba7…`
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…`

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 ndc (product): 71335-1118
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 ndc (product): 0378-0014
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 ndc (product): 51407-121
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
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 ndc (product): 51079-670

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 17 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-0014	Methotrexate	methotrexate	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0014	Methotrexate	methotrexate	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0014	Methotrexate	methotrexate	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0014	Methotrexate	methotrexate	Mylan Pharmaceuticals Inc.	ANDA	Current
51079-570	Methotrexate	methotrexate	Mylan Institutional Inc.	ANDA	Current
51079-670	Methotrexate	methotrexate	Mylan Institutional Inc.	ANDA	Current
51079-670	Methotrexate	methotrexate	Mylan Institutional Inc.	ANDA	Current
51079-670	Methotrexate	methotrexate	Mylan Institutional Inc.	ANDA	Current
51079-670	Methotrexate	methotrexate	Mylan Institutional Inc.	ANDA	Current
51407-121	Methotrexate	methotrexate	Golden State Medical Supply Inc.	ANDA	Current
51407-121	Methotrexate	methotrexate	Golden State Medical Supply	ANDA	Current
51407-121	Methotrexate	methotrexate	Golden State Medical Supply, Inc.	ANDA	Current
51407-121	Methotrexate	methotrexate	Golden State Medical Supply, Inc.	ANDA	Current
71335-1118	Methotrexate	methotrexate	Bryant Ranch Prepack	ANDA	Current
71335-1118	Methotrexate	methotrexate	Bryant Ranch Prepack	ANDA	Current
71335-1118	Methotrexate	methotrexate	Bryant Ranch Prepack	ANDA	Current
71335-1118	Methotrexate	methotrexate	Bryant Ranch Prepack	ANDA	Current