Application 081099

Type: ANDA
Sponsor: BARR

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
A081099-001	METHOTREXATE SODIUM	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB		1990-10-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A081099-001	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	A081099-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1990-10-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A081099-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1990-10-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A081099-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1990-10-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A081099-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1990-10-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A081099-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1990-10-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A081099-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1990-10-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A081099-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1990-10-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A081099-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1990-10-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A081099-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1990-10-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A081099-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1990-10-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A081099-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1990-10-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A081099-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1990-10-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A081099-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1990-10-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A081099-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1990-10-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A081099-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1990-10-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A081099-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1990-10-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A081099-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1990-10-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A081099-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1990-10-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A081099-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1990-10-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A081099-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1990-10-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A081099-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1990-10-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A081099-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1990-10-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A081099-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1990-10-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A081099-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1990-10-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A081099-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1990-10-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A081099-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1990-10-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A081099-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1990-10-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A081099-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1990-10-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A081099-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1990-10-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A081099-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1990-10-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A081099-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1990-10-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A081099-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1990-10-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A081099-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1990-10-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A081099-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1990-10-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A081099-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1990-10-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A081099-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1990-10-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A081099-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1990-10-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A081099-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1990-10-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A081099-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1990-10-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A081099-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	1990-10-15	`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	A081099-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A081099-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A081099-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A081099-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A081099-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A081099-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A081099-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A081099-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A081099-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A081099-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A081099-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A081099-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A081099-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A081099-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A081099-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A081099-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A081099-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A081099-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A081099-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A081099-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A081099-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A081099-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A081099-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A081099-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A081099-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A081099-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A081099-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A081099-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A081099-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A081099-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A081099-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A081099-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A081099-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A081099-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A081099-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A081099-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A081099-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A081099-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A081099-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A081099-001	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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Methotrexate	METHOTREXATE	AvKARE	757d6cef-6696-7a1c-8074-01258aaa8bdd	2026-07-23	Boxed warning, Adverse reactions	Exact identifier application applno (ANDA): 081099 application number: ANDA081099 ndc (product): 42291-594
Methotrexate	METHOTREXATE	Teva Pharmaceuticals USA, Inc.	9b34b1d8-d125-41a2-9f6f-3fab67b573bd	2026-06-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 081099 application number: ANDA081099 ndc (product): 0555-0572
Methotrexate	METHOTREXATE	A-S Medication Solutions	22e10810-16fb-4c84-bccf-972405b77ef8	2026-02-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 081099 application number: ANDA081099 ndc (product): 50090-5457
Methotrexate	METHOTREXATE	Bryant Ranch Prepack	e6611304-4622-4b2e-9b94-57fbad023ae2	2024-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 081099 application number: ANDA081099 ndc (product): 71335-0782

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 20 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0555-0572	Methotrexate	Methotrexate	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-0572	Methotrexate	Methotrexate	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-0572	Methotrexate	Methotrexate	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-0572	Methotrexate	Methotrexate	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-0572	Methotrexate	Methotrexate	Teva Pharmaceuticals USA,	ANDA	Current
0555-0572	Methotrexate	Methotrexate	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-0572	Methotrexate	Methotrexate	Teva Pharmaceuticals USA, Inc.	ANDA	Current
21695-111	Methotrexate	Methotrexate sodium	Rebel Distributors Corp	ANDA	Current
42291-594	Methotrexate	Methotrexate	AvKARE, Inc.	ANDA	Current
42291-594	Methotrexate	Methotrexate	AvKARE, Inc.	ANDA	Current
43063-439	Methotrexate	Methotrexate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-439	Methotrexate	Methotrexate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-439	Methotrexate	Methotrexate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
50090-2345	Methotrexate	Methotrexate	A-S Medication Solutions	ANDA	Current
50090-5457	Methotrexate	Methotrexate	A-S Medication Solutions	ANDA	Current
50090-5457	Methotrexate	Methotrexate	A-S Medication Solutions	ANDA	Current
50090-5457	Methotrexate	Methotrexate	A-S Medication Solutions	ANDA	Current
71335-0782	Methotrexate	Methotrexate	Bryant Ranch Prepack	ANDA	Current
71335-0782	Methotrexate	Methotrexate	Bryant Ranch Prepack	ANDA	Current
71335-0782	Methotrexate	Methotrexate	Bryant Ranch Prepack	ANDA	Current