Application 213343

Type: ANDA
Sponsor: ACCORD HLTHCARE

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
A213343-001	METHOTREXATE SODIUM	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB		2020-01-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213343-001	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.

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	A213343-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-01-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213343-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-01-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213343-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-01-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213343-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-01-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213343-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-01-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213343-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-01-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213343-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-01-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213343-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-01-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213343-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-01-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213343-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-01-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213343-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-01-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213343-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-01-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213343-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-01-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213343-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-01-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213343-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-01-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213343-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-01-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213343-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-01-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213343-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-01-24	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213343-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-01-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213343-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-01-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213343-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-01-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A213343-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-01-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A213343-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-01-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A213343-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-01-24	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213343-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-01-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213343-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-01-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213343-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-01-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213343-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-01-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213343-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-01-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213343-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-01-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213343-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-01-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213343-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-01-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213343-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-01-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213343-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-01-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213343-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-01-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213343-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-01-24	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213343-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-01-24	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213343-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-01-24	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A213343-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213343-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213343-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213343-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213343-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213343-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213343-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213343-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213343-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213343-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213343-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213343-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213343-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213343-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213343-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213343-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213343-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213343-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213343-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213343-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213343-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A213343-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A213343-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A213343-001	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213343-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213343-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213343-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213343-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213343-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213343-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213343-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213343-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213343-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213343-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213343-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213343-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213343-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213343-001	AB	1	`a50c72e98297…`

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	Accord Healthcare Inc.	874c7f43-a3be-4236-89cc-24c44e3c5813	2026-05-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213343 application number: ANDA213343 ndc (product): 16729-486
Methotrexate	METHOTREXATE	Bryant Ranch Prepack	4741a44f-0d0b-4380-84f6-231a8d1560fb	2026-05-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213343 application number: ANDA213343 ndc (product): 71335-1772
Methotrexate	METHOTREXATE	NuCare Pharmaceuticals, Inc.	50b2cfc7-dfe4-4406-e063-6294a90a2527	2026-04-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213343 application number: ANDA213343
Methotrexate	METHOTREXATE	Coupler LLC	2f20d43e-a4b3-a839-e063-6394a90ace38	2025-02-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213343 application number: ANDA213343
Methotrexate	METHOTREXATE	Proficient Rx LP	a76808f0-38a7-4b54-a4fb-3584f9058ae5	2024-08-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213343 application number: ANDA213343

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16729-486	Methotrexate	Methotrexate	Accord Healthcare, Inc.	ANDA	Current
16729-486	Methotrexate	Methotrexate	Accord Healthcare Inc.	ANDA	Current
16729-486	Methotrexate	Methotrexate	Accord Healthcare Inc.	ANDA	Current
16729-486	Methotrexate	Methotrexate	Accord Healthcare Inc.	ANDA	Current
70518-3263	Methotrexate	Methotrexate	REMEDYREPACK INC.	ANDA	Current
70518-3263	Methotrexate	Methotrexate	REMEDYREPACK INC.	ANDA	Current
70518-3263	Methotrexate	Methotrexate	REMEDYREPACK INC.	ANDA	Current
70518-3263	Methotrexate	Methotrexate	REMEDYREPACK INC.	ANDA	Current
70518-3263	Methotrexate	Methotrexate	REMEDYREPACK INC.	ANDA	Current
71335-1772	Methotrexate	Methotrexate	Bryant Ranch Prepack	ANDA	Current
71335-1772	Methotrexate	Methotrexate	Bryant Ranch Prepack	ANDA	Current
71335-1772	Methotrexate	Methotrexate	Bryant Ranch Prepack	ANDA	Current