Application 214121

Type: NDA
Sponsor: ACCORD HLTHCARE INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	METHOTREXATE	METHOTREXATE	INJECTABLE;INJECTION	5G/50ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N214121-001	METHOTREXATE	METHOTREXATE	5GM/50ML (100MG/ML)	SOLUTION / INTRAVENOUS		RLD	2020-08-24

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	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N214121-001	METHOTREXATE	5GM/50ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-08-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N214121-001	METHOTREXATE	5GM/50ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-08-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N214121-001	METHOTREXATE	5GM/50ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-08-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214121-001	METHOTREXATE	5GM/50ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-08-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214121-001	METHOTREXATE	5GM/50ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-08-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214121-001	METHOTREXATE	5GM/50ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-08-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214121-001	METHOTREXATE	5GM/50ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-08-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214121-001	METHOTREXATE	5GM/50ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-08-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214121-001	METHOTREXATE	5GM/50ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-08-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214121-001	METHOTREXATE	5GM/50ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-08-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214121-001	METHOTREXATE	5GM/50ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-08-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N214121-001	METHOTREXATE	5GM/50ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-08-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214121-001	METHOTREXATE	5GM/50ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-08-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214121-001	METHOTREXATE	5GM/50ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-08-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214121-001	METHOTREXATE	5GM/50ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-08-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N214121-001	METHOTREXATE	5GM/50ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-08-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N214121-001	METHOTREXATE	5GM/50ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-08-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N214121-001	METHOTREXATE	5GM/50ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-08-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N214121-001	METHOTREXATE	5GM/50ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-08-24	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N214121-001	METHOTREXATE	5GM/50ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-08-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N214121-001	METHOTREXATE	5GM/50ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-08-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N214121-001	METHOTREXATE	5GM/50ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-08-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N214121-001	METHOTREXATE	5GM/50ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-08-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N214121-001	METHOTREXATE	5GM/50ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-08-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N214121-001	METHOTREXATE	5GM/50ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-08-24	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N214121-001	METHOTREXATE	5GM/50ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-08-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N214121-001	METHOTREXATE	5GM/50ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-08-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N214121-001	METHOTREXATE	5GM/50ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-08-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N214121-001	METHOTREXATE	5GM/50ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-08-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N214121-001	METHOTREXATE	5GM/50ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-08-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N214121-001	METHOTREXATE	5GM/50ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-08-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N214121-001	METHOTREXATE	5GM/50ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-08-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N214121-001	METHOTREXATE	5GM/50ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-08-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N214121-001	METHOTREXATE	5GM/50ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-08-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N214121-001	METHOTREXATE	5GM/50ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-08-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N214121-001	METHOTREXATE	5GM/50ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-08-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N214121-001	METHOTREXATE	5GM/50ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-08-24	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N214121-001	METHOTREXATE	5GM/50ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-08-24	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N214121-001	METHOTREXATE	5GM/50ML (100MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-08-24	`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 2 of 3 · 45 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
METHOTREXATE	METHOTREXATE	Alembic Pharmaceuticals Limited	e98b2abd-8068-482e-9ce3-1ab262f0838e	2026-04-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METHOTREXATE generic name: METHOTREXATE
Methotrexate	METHOTREXATE	Golden State Medical Supply, Inc.	6f14ced9-c16b-905a-e053-2a91aa0a031e	2026-04-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Methotrexate generic name: METHOTREXATE
Methotrexate	METHOTREXATE	Safecor Health LLC	f177e6fa-c482-432d-8208-937468ab3f10	2026-01-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Methotrexate generic name: METHOTREXATE
Methotrexate	METHOTREXATE	AvPAK	4992fdaa-b880-ee25-e063-6394a90af03b	2026-01-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Methotrexate generic name: METHOTREXATE
Methotrexate	METHOTREXATE	Chartwell RX, LLC	2609da8f-80dc-448e-8eba-35d11488ce7f	2025-12-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Methotrexate generic name: METHOTREXATE
Rasuvo	METHOTREXATE	Medexus Pharma Inc.	d0075461-0e7e-4967-9c9b-d6440e912c0e	2025-12-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHOTREXATE
Methotrexate	METHOTREXATE	Hospira, Inc.	0e30eaef-5a09-4104-8a11-c32933eadeab	2025-08-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Methotrexate generic name: METHOTREXATE
Methotrexate	METHOTREXATE SODIUM	Fresenius Kabi USA, LLC	ec476b11-0b3c-4139-b1eb-a3daa76bc271	2025-08-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Methotrexate
Methotrexate	METHOTREXATE	Mylan Institutional Inc.	8df0780e-0fbd-4ab8-80b0-7a5eaa08ec0a	2025-07-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Methotrexate generic name: METHOTREXATE
Methotrexate	METHOTREXATE	Hikma Pharmaceuticals USA Inc.	b080eb92-fc72-4ce6-a7ab-3f9ce2415526	2025-07-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Methotrexate generic name: METHOTREXATE
Methotrexate	METHOTREXATE	Teva Parenteral Medicines, Inc.	346ec9ce-dc98-4a55-b55e-d3af11f2d703	2025-07-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Methotrexate generic name: METHOTREXATE
METHOTREXATE	METHOTREXATE	Eugia US LLC	63bb6fbf-dd59-4edc-af8f-d0c397ca1262	2025-07-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METHOTREXATE generic name: METHOTREXATE
Methotrexate	METHOTREXATE	Hospira, Inc.	bd287e89-32f9-4396-95fa-4b562869f476	2025-06-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Methotrexate generic name: METHOTREXATE
Methotrexate	METHOTREXATE	Hospira, Inc.	0d63ba29-b692-41b4-87e8-351265c8273f	2025-06-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Methotrexate generic name: METHOTREXATE
Methotrexate	METHOTREXATE	Coupler LLC	2f20d43e-a4b3-a839-e063-6394a90ace38	2025-02-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Methotrexate generic name: METHOTREXATE
Otrexup	METHOTREXATE	Antares Pharma, Inc.	9ab8ce16-f7de-41d4-a4c8-1c742621b6d5	2025-01-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHOTREXATE
Methotrexate	METHOTREXATE	NuCare Pharmaceuticals, Inc.	2b61822e-b488-5eaf-e063-6394a90a2dcd	2025-01-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Methotrexate generic name: METHOTREXATE
Methotrexate	METHOTREXATE	Zydus Lifesciences Limited	59ea7b32-2b6d-4197-92c3-015936f04ebe	2024-12-05		Name fallback brand name: Methotrexate generic name: METHOTREXATE
Methotrexate	METHOTREXATE	Bryant Ranch Prepack	e6611304-4622-4b2e-9b94-57fbad023ae2	2024-10-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Methotrexate generic name: METHOTREXATE
Methotrexate	METHOTREXATE	Hikma Pharmaceuticals USA Inc.	8593f7fc-eabe-44ae-bb05-b3d7d408e4f7	2024-09-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Methotrexate generic name: METHOTREXATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85383	SUPPL	2026-03-16
85391	SUPPL	2026-03-12
82432	SUPPL	2025-06-02
82431	SUPPL	2025-06-02
79594	SUPPL	2024-09-16
70530	SUPPL	2022-03-16
70484	SUPPL	2022-03-11
65389	ORIG	2020-11-30
64413	ORIG	2020-08-25