Application 011719

Type: NDA
Sponsor: HOSPIRA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	METHOTREXATE SODIUM	METHOTREXATE SODIUM	INJECTABLE;INJECTION	EQ 20MG BASE/VIAL	No	No
003	METHOTREXATE SODIUM	METHOTREXATE SODIUM	INJECTABLE;INJECTION	EQ 50MG BASE/VIAL	No	No
004	METHOTREXATE SODIUM	METHOTREXATE SODIUM	INJECTABLE;INJECTION	EQ 2.5MG BASE/ML	No	No
005	METHOTREXATE SODIUM	METHOTREXATE SODIUM	INJECTABLE;INJECTION	EQ 25MG BASE/ML	No	No
006	METHOTREXATE SODIUM	METHOTREXATE SODIUM	INJECTABLE;INJECTION	EQ 100MG BASE/VIAL	No	No
007	METHOTREXATE LPF	METHOTREXATE SODIUM	INJECTABLE;INJECTION	EQ 25MG BASE/ML	No	No
009	METHOTREXATE SODIUM PRESERVATIVE FREE	METHOTREXATE SODIUM	INJECTABLE;INJECTION	EQ 1GM BASE/VIAL	No	No
010	METHOTREXATE SODIUM	METHOTREXATE SODIUM	INJECTABLE;INJECTION	EQ 50MG BASE/2ML (EQ 25MG BASE/ML)	Yes	Yes
011	METHOTREXATE PRESERVATIVE FREE	METHOTREXATE SODIUM	INJECTABLE;INJECTION	EQ 2.5GM BASE/100ML (EQ 25MG BASE/ML)	No	No
012	METHOTREXATE SODIUM PRESERVATIVE FREE	METHOTREXATE SODIUM	INJECTABLE;INJECTION	EQ 1GM BASE/40ML (EQ 25MG BASE/ML)	Yes	Yes
013	METHOTREXATE PRESERVATIVE FREE	METHOTREXATE SODIUM	INJECTABLE;INJECTION	EQ 500MG BASE/20ML (EQ 25MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
014	METHOTREXATE PRESERVATIVE FREE	METHOTREXATE SODIUM	INJECTABLE;INJECTION	EQ 20MG BASE/2ML (EQ 10MG BASE/ML)	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 12 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N011719-001	METHOTREXATE SODIUM	METHOTREXATE SODIUM	EQ 20MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982
N011719-003	METHOTREXATE SODIUM	METHOTREXATE SODIUM	EQ 50MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982
N011719-004	METHOTREXATE SODIUM	METHOTREXATE SODIUM	EQ 2.5MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982
N011719-005	METHOTREXATE SODIUM	METHOTREXATE SODIUM	EQ 25MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982
N011719-006	METHOTREXATE SODIUM	METHOTREXATE SODIUM	EQ 100MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982
N011719-007	METHOTREXATE LPF	METHOTREXATE SODIUM	EQ 25MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1982-03-31
N011719-009	METHOTREXATE SODIUM PRESERVATIVE FREE	METHOTREXATE SODIUM	EQ 1GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1988-04-07
N011719-010	METHOTREXATE SODIUM	METHOTREXATE SODIUM	EQ 50MG BASE/2ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2004-12-15
N011719-011	METHOTREXATE PRESERVATIVE FREE	METHOTREXATE SODIUM	EQ 2.5GM BASE/100ML (EQ 25MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	2005-04-13
N011719-012	METHOTREXATE SODIUM PRESERVATIVE FREE	METHOTREXATE SODIUM	EQ 1GM BASE/40ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2005-04-13
N011719-013	METHOTREXATE PRESERVATIVE FREE	METHOTREXATE SODIUM	EQ 500MG BASE/20ML (EQ 25MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	2005-04-13
N011719-014	METHOTREXATE PRESERVATIVE FREE	METHOTREXATE SODIUM	EQ 20MG BASE/2ML (EQ 10MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	2005-04-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N011719-010	AP
N011719-012	AP

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 13 · 516 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N011719-001	METHOTREXATE SODIUM	EQ 20MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N011719-003	METHOTREXATE SODIUM	EQ 50MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N011719-004	METHOTREXATE SODIUM	EQ 2.5MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N011719-005	METHOTREXATE SODIUM	EQ 25MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N011719-006	METHOTREXATE SODIUM	EQ 100MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N011719-007	METHOTREXATE LPF	EQ 25MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1982-03-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N011719-009	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 1GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1988-04-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N011719-010	METHOTREXATE SODIUM	EQ 50MG BASE/2ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2004-12-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N011719-011	METHOTREXATE PRESERVATIVE FREE	EQ 2.5GM BASE/100ML (EQ 25MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	2005-04-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N011719-012	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 1GM BASE/40ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2005-04-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N011719-013	METHOTREXATE PRESERVATIVE FREE	EQ 500MG BASE/20ML (EQ 25MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	2005-04-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N011719-014	METHOTREXATE PRESERVATIVE FREE	EQ 20MG BASE/2ML (EQ 10MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	2005-04-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N011719-001	METHOTREXATE SODIUM	EQ 20MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N011719-003	METHOTREXATE SODIUM	EQ 50MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N011719-004	METHOTREXATE SODIUM	EQ 2.5MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N011719-005	METHOTREXATE SODIUM	EQ 25MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N011719-006	METHOTREXATE SODIUM	EQ 100MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N011719-007	METHOTREXATE LPF	EQ 25MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1982-03-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N011719-009	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 1GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1988-04-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N011719-010	METHOTREXATE SODIUM	EQ 50MG BASE/2ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2004-12-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N011719-011	METHOTREXATE PRESERVATIVE FREE	EQ 2.5GM BASE/100ML (EQ 25MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	2005-04-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N011719-012	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 1GM BASE/40ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2005-04-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N011719-013	METHOTREXATE PRESERVATIVE FREE	EQ 500MG BASE/20ML (EQ 25MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	2005-04-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N011719-014	METHOTREXATE PRESERVATIVE FREE	EQ 20MG BASE/2ML (EQ 10MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	2005-04-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N011719-001	METHOTREXATE SODIUM	EQ 20MG BASE/VIAL	INJECTABLE / INJECTION		RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N011719-003	METHOTREXATE SODIUM	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION		RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N011719-004	METHOTREXATE SODIUM	EQ 2.5MG BASE/ML	INJECTABLE / INJECTION		RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N011719-005	METHOTREXATE SODIUM	EQ 25MG BASE/ML	INJECTABLE / INJECTION		RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N011719-006	METHOTREXATE SODIUM	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION		RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N011719-007	METHOTREXATE LPF	EQ 25MG BASE/ML	INJECTABLE / INJECTION		RLD	1982-03-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N011719-009	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		RLD	1988-04-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N011719-010	METHOTREXATE SODIUM	EQ 50MG BASE/2ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2004-12-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N011719-011	METHOTREXATE PRESERVATIVE FREE	EQ 2.5GM BASE/100ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION		RLD	2005-04-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N011719-012	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 1GM BASE/40ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2005-04-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N011719-013	METHOTREXATE PRESERVATIVE FREE	EQ 500MG BASE/20ML (EQ 25MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	2005-04-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N011719-014	METHOTREXATE PRESERVATIVE FREE	EQ 20MG BASE/2ML (EQ 10MG BASE/ML)	INJECTABLE / INJECTION		RLD	2005-04-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011719-001	METHOTREXATE SODIUM	EQ 20MG BASE/VIAL	INJECTABLE / INJECTION		RLD, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011719-003	METHOTREXATE SODIUM	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION		RLD, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011719-004	METHOTREXATE SODIUM	EQ 2.5MG BASE/ML	INJECTABLE / INJECTION		RLD, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011719-005	METHOTREXATE SODIUM	EQ 25MG BASE/ML	INJECTABLE / INJECTION		RLD, Approved before 1982		`31067a03dcf5…`

Observed Orange Book normalized TE history#

Normalized TE history page 3 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-09-29 23:25 UTC	2022-09	N011719-010	AP	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N011719-012	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N011719-010	AP	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N011719-012	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N011719-010	AP	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N011719-012	AP	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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Methotrexate	METHOTREXATE	Hospira, Inc.	0e30eaef-5a09-4104-8a11-c32933eadeab	2025-08-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 011719 application number: NDA011719 ndc (product): 61703-350 ndc (product): 61703-408
Methotrexate	METHOTREXATE	Hospira, Inc.	bd287e89-32f9-4396-95fa-4b562869f476	2025-06-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 011719 application number: NDA011719 ndc (product): 61703-124
Methotrexate	METHOTREXATE	Hospira, Inc.	0d63ba29-b692-41b4-87e8-351265c8273f	2025-06-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 011719 application number: NDA011719 ndc (product): 61703-350 ndc (product): 61703-408

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 27 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
61703-124	Methotrexate	Methotrexate	Hospira, Inc.	NDA	Current
61703-350	Methotrexate	Methotrexate	Hospira, Inc.	NDA	Current
61703-350	Methotrexate	Methotrexate	Hospira, Inc.	NDA	Current
61703-350	Methotrexate	Methotrexate	Hospira, Inc.	NDA	Current
61703-350	Methotrexate	Methotrexate	Hospira, Inc.	NDA	Current
61703-350	Methotrexate	Methotrexate	Hospira, Inc.	NDA	Current
61703-350	Methotrexate	Methotrexate	Hospira, Inc.	NDA	Current
61703-350	Methotrexate	Methotrexate	Hospira, Inc.	NDA	Current
61703-350	Methotrexate	Methotrexate	Hospira, Inc.	NDA	Current
61703-350	Methotrexate	Methotrexate	Hospira, Inc.	NDA	Current
61703-350	Methotrexate	Methotrexate	Hospira, Inc.	NDA	Current
61703-350	Methotrexate	Methotrexate	Hospira, Inc.	NDA	Current
61703-350	Methotrexate	Methotrexate	Hospira, Inc.	NDA	Current
61703-350	Methotrexate	Methotrexate	Hospira, Inc.	NDA	Current
61703-350	Methotrexate	Methotrexate	Hospira, Inc.	NDA	Current
61703-350	Methotrexate	Methotrexate	Hospira, Inc.	NDA	Current
61703-408	Methotrexate	Methotrexate	Hospira, Inc.	NDA	Current
61703-408	Methotrexate	Methotrexate	Hospira, Inc.	NDA	Current
61703-408	Methotrexate	METHOTREXATE	Hospira, Inc.	NDA	Current
61703-408	Methotrexate	Methotrexate	Hospira, Inc.	NDA	Current
61703-408	Methotrexate	Methotrexate	Hospira, Inc.	NDA	Current
61703-408	Methotrexate	METHOTREXATE	Hospira, Inc.	NDA	Current
61703-408	Methotrexate	Methotrexate	Hospira, Inc.	NDA	Current
61703-408	Methotrexate	Methotrexate	Hospira, Inc.	NDA	Current
61703-408	Methotrexate	Methotrexate	Hospira, Inc.	NDA	Current
61703-408	Methotrexate	Methotrexate	Hospira, Inc.	NDA	Current
61703-408	Methotrexate	Methotrexate	Hospira, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82358	SUPPL	2025-05-30
82341	SUPPL	2025-05-29
79105	SUPPL	2024-07-16
79104	SUPPL	2024-07-16
76613	SUPPL	2024-07-16
76607	SUPPL	2023-11-17
70917	SUPPL	2022-05-03
70913	SUPPL	2022-05-03
66922	SUPPL	2021-03-30
66921	SUPPL	2021-03-30
54048	SUPPL	2018-05-08
54036	SUPPL	2018-05-07
53060	SUPPL	2018-03-20
53041	SUPPL	2018-03-16
10775	SUPPL	2015-11-25
11956	SUPPL	2015-11-23
33054	SUPPL	2011-11-04
11955	SUPPL	2011-11-03
11954	SUPPL	2005-04-19
11953	SUPPL	2004-12-30
10774	SUPPL	2004-02-03
11952	SUPPL	2004-02-02
11951	SUPPL	2003-08-06
283	SUPPL	2003-01-03
11950	SUPPL	2002-02-20
282	SUPPL	2002-02-20