Methotrexate

Product NDC: 61703-350
11-digit product format: 617030350
Labeler code: 61703
Product ID: 61703-350_37b3e76b-ac3d-4f93-adf1-91f52f676b8a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Methotrexate
Dosage form: INJECTION, SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler: Hospira, Inc.
Application: NDA011719
Marketing category: NDA
Marketing start: 2014-09-25
Substance: METHOTREXATE SODIUM
Active strength: 25 mg/mL
Pharmacologic classes: Folate Analog Metabolic Inhibitor [EPC], Folic Acid Metabolism Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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

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SODIUM	METHOTREXATE SODIUM	EQ 20MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982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SODIUM	METHOTREXATE SODIUM	EQ 50MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982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SODIUM	METHOTREXATE SODIUM	EQ 2.5MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982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SODIUM	METHOTREXATE SODIUM	EQ 25MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982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SODIUM	METHOTREXATE SODIUM	EQ 100MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982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LPF	METHOTREXATE SODIUM	EQ 25MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1982-03-31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FREE	METHOTREXATE SODIUM	EQ 1GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1988-04-07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 · 504 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
2026-08-18 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…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011719-006	METHOTREXATE SODIUM	EQ 100MG BASE/VIAL	INJECTABLE / INJECTION		RLD, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011719-007	METHOTREXATE LPF	EQ 25MG BASE/ML	INJECTABLE / INJECTION		RLD	1982-03-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011719-009	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		RLD	1988-04-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011719-010	METHOTREXATE SODIUM	EQ 50MG BASE/2ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2004-12-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011719-011	METHOTREXATE PRESERVATIVE FREE	EQ 2.5GM BASE/100ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION		RLD	2005-04-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011719-012	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 1GM BASE/40ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2005-04-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	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	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011719-014	METHOTREXATE PRESERVATIVE FREE	EQ 20MG BASE/2ML (EQ 10MG BASE/ML)	INJECTABLE / INJECTION		RLD	2005-04-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N011719-001	METHOTREXATE SODIUM	EQ 20MG BASE/VIAL	INJECTABLE / INJECTION		RLD, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N011719-003	METHOTREXATE SODIUM	EQ 50MG BASE/VIAL	INJECTABLE / INJECTION		RLD, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N011719-004	METHOTREXATE SODIUM	EQ 2.5MG BASE/ML	INJECTABLE / INJECTION		RLD, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N011719-005	METHOTREXATE SODIUM	EQ 25MG BASE/ML	INJECTABLE / INJECTION		RLD, Approved before 1982		`6a471c1ec25d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 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	N011719-010	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N011719-012	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N011719-010	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N011719-012	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011719-010	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011719-012	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N011719-010	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N011719-012	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N011719-010	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N011719-012	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N011719-010	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N011719-012	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N011719-010	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N011719-012	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N011719-010	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N011719-012	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N011719-010	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N011719-012	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N011719-010	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N011719-012	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N011719-010	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N011719-012	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N011719-010	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N011719-012	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N011719-010	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N011719-012	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N011719-010	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N011719-012	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N011719-010	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N011719-012	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N011719-010	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N011719-012	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N011719-010	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N011719-012	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N011719-010	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N011719-012	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N011719-010	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N011719-012	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N011719-010	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N011719-012	AP	1	`bb7c543d1eb4…`

Additional Listing Data#

Finished product: Yes
Brand name base: Methotrexate
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
METHOTREXATE SODIUM	25 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
3IG1E710ZN	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1655956	Internal RxNorm lookup
1946772	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
0e30eaef-5a09-4104-8a11-c32933eadeab	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
2eb9a854-4fbc-9bbe-3199-41fc1018a1f0	Product name	9	20250224
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
3082de91-569a-4d57-b379-acbf37f1d5c3	Product name	1	20210312
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
f76135bc-a210-42d9-851b-1b73cbaccdb3	Product name	1	20200511
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
423544b2-e325-49ee-8910-4c5dfe41906f	Product name	1	20181120
c9fd924b-0a8d-4d53-bf70-11070e24e4dd	Product name	2	20181120
ce1e7cc6-4850-4cb1-8dde-8010b2fbc359	Product name	1	20181120
eb454f54-2806-4c31-a08b-8dcb08261099	Product name	2	20181120
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
d9cebc09-c68d-46f5-bdcd-fd82e945cc27	Product name	1	20170705
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
16ba0c1e-2371-48a4-8b4c-a9a338dfe1f3	Product name	2	20160504
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
88514aea-9d58-4ed2-b135-9811fb14c8fb	Product name	1	20141209
0eba90a2-1cca-7e7b-28a5-85a09e2bc9a4	Product name	1	20140508
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
9869efd7-d6dd-0665-5b67-53adbe6ef15e	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
61703-350-37	Methotrexate	2 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION	2	19
61703-350-38	Methotrexate	5 in 1 CARTON	INJECTION, SOLUTION	5	19
61703-350-09	Methotrexate	2 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION	2	17
61703-350-10	Methotrexate	5 in 1 CARTON	INJECTION, SOLUTION	5	17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61703-350-09	ML - Milliliter	61703-350	fc6c6bc0-7779-4e5c-826c-f3b31b2f75df	1	2017-07-07
61703-350-10	ML - Milliliter	61703-350	a56537db-5dd4-4fb1-a7d8-dbb4bef377d5	1	2014-12-01
61703-350-37	ML - Milliliter	61703-350	34ee0d7d-41a6-469c-8aad-a3e5d8ffd9a1	1	2016-12-07
61703-350-38	ML - Milliliter	61703-350	c3053f4b-fab5-4086-9749-d05f3dca6057	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
METHOTREXATE SODIUM	ACTIVE INGREDIENT	3IG1E710ZN	METHOTREXATE (METHOTREXATE SODIUM) INJECTION, SOLUTION [HOSPIRA WORLDWIDE, INC.]	1
METHOTREXATE	ACTIVE MOIETY	YL5FZ2Y5U1	METHOTREXATE (METHOTREXATE SODIUM) INJECTION, SOLUTION [HOSPIRA WORLDWIDE, INC.]	1
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	METHOTREXATE (METHOTREXATE SODIUM) INJECTION, SOLUTION [HOSPIRA WORLDWIDE, INC.]	1
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	METHOTREXATE (METHOTREXATE SODIUM) INJECTION, SOLUTION [HOSPIRA WORLDWIDE, INC.]	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	METHOTREXATE (METHOTREXATE SODIUM) INJECTION, SOLUTION [HOSPIRA WORLDWIDE, INC.]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	METHOTREXATE (METHOTREXATE SODIUM) INJECTION, SOLUTION [HOSPIRA WORLDWIDE, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	METHOTREXATE (METHOTREXATE SODIUM) INJECTION, SOLUTION [HOSPIRA WORLDWIDE, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61703-350	METHOTREXATE INJECTION, SOLUTION [HOSPIRA, INC.]	18	Current NDC, Legacy NDC, 2 package rows	20240829_0d63ba29-b692-41b4-87e8-351265c8273f.zip
61703-350	METHOTREXATE INJECTION, SOLUTION [HOSPIRA, INC.]	15	Current NDC, Legacy NDC, 2 package rows	20240829_0e30eaef-5a09-4104-8a11-c32933eadeab.zip

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
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
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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
3IG1E710ZN	METHOTREXATE SODIUM	7413-34-5	METHOTREXATE SODIUM
YL5FZ2Y5U1	METHOTREXATE	59-05-2	Methotrexate

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1655956	methotrexate 1 GM in 40 ML Injection	PSN	0d63ba29-b692-41b4-87e8-351265c8273f	19
1946772	methotrexate 25 MG/mL Injectable Solution	PSN	0d63ba29-b692-41b4-87e8-351265c8273f	19
1655956	40 ML methotrexate 25 MG/ML Injection	SCD	0d63ba29-b692-41b4-87e8-351265c8273f	19
1946772	methotrexate 25 MG/ML Injectable Solution	SCD	0d63ba29-b692-41b4-87e8-351265c8273f	19
1946772	methotrexate (as methotrexate sodium) 25 MG/ML Injectable Solution	SY	0d63ba29-b692-41b4-87e8-351265c8273f	19
1655956	methotrexate 1 GM per 40 ML Injection	SY	0d63ba29-b692-41b4-87e8-351265c8273f	19
1655956	methotrexate 1 GM in 40 ML Injection	PSN	0e30eaef-5a09-4104-8a11-c32933eadeab	17
1946772	methotrexate 25 MG/mL Injectable Solution	PSN	0e30eaef-5a09-4104-8a11-c32933eadeab	17
1655956	40 ML methotrexate 25 MG/ML Injection	SCD	0e30eaef-5a09-4104-8a11-c32933eadeab	17
1946772	methotrexate 25 MG/ML Injectable Solution	SCD	0e30eaef-5a09-4104-8a11-c32933eadeab	17
1946772	methotrexate (as methotrexate sodium) 25 MG/ML Injectable Solution	SY	0e30eaef-5a09-4104-8a11-c32933eadeab	17
1655956	methotrexate 1 GM per 40 ML Injection	SY	0e30eaef-5a09-4104-8a11-c32933eadeab	17

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61703-350-09	61703035009	2 mL in 1 VIAL, MULTI-DOSE	2 ml					Historical
61703-350-10	61703035010	5 VIAL, MULTI-DOSE in 1 CARTON (61703-350-10) / 2 mL in 1 VIAL, MULTI-DOSE (61703-350-09)		2014-09-25	0000-00-00	No	No	Current
61703-350-37	61703035037	2 mL in 1 VIAL, MULTI-DOSE	2 ml					Historical
61703-350-38	61703035038	5 VIAL, MULTI-DOSE in 1 CARTON (61703-350-38) / 2 mL in 1 VIAL, MULTI-DOSE (61703-350-37)		2005-07-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Methotrexate	Hospira, Inc. \| Hospira Australia Pty Ltd	2025-08-22	HUMAN PRESCRIPTION DRUG LABEL	17
Methotrexate	Hospira, Inc. \| Hospira Australia Pty Ltd	2025-06-10	HUMAN PRESCRIPTION DRUG LABEL	19