Methotrexate

Product NDC: 61703-350
Requested package NDC: 61703-350-38
11-digit product format: 617030350
Labeler code: 61703
Product ID: 61703-350_6d38984b-4deb-42c3-bf1d-4e0b0c8887e6
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: 2005-07-27
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: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 45.

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SODIUM	METHOTREXATE SODIUM	EQ 20MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982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SODIUM	METHOTREXATE SODIUM	EQ 50MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982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SODIUM	METHOTREXATE SODIUM	EQ 2.5MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982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SODIUM	METHOTREXATE SODIUM	EQ 25MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982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SODIUM	METHOTREXATE SODIUM	EQ 100MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982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LPF	METHOTREXATE SODIUM	EQ 25MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1982-03-31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 14 · 540 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
2026-11-14 07:37:17	2026-10	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		`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	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		`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	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		`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	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		`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	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		`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	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	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	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	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N011719-010	METHOTREXATE SODIUM	EQ 50MG BASE/2ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2004-12-15	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	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	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N011719-012	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 1GM BASE/40ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2005-04-13	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	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	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	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	`d4dbc9d85df4…`
2026-10-15 13:18:30	2026-09	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		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	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		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	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		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	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		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	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		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	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	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	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	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N011719-010	METHOTREXATE SODIUM	EQ 50MG BASE/2ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2004-12-15	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	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	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N011719-012	METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 1GM BASE/40ML (EQ 25MG BASE/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2005-04-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	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	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	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	`c2088c7a36db…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 90 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-11-14 07:37:17	2026-10	N011719-010	AP	1	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N011719-012	AP	1	`d4dbc9d85df4…`
2026-10-15 13:18:30	2026-09	N011719-010	AP	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N011719-012	AP	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N011719-010	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N011719-012	AP	1	`84e616aacf4f…`
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…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Methotrexate
Listing expiration: 2027-12-31

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
0d63ba29-b692-41b4-87e8-351265c8273f	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

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	Marketing start	Marketing end	Sample	Exclude flag	Status
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	2026-10-29	HUMAN PRESCRIPTION DRUG LABEL	18
Methotrexate	Hospira, Inc. \| Hospira Australia Pty Ltd	2026-10-27	HUMAN PRESCRIPTION DRUG LABEL	20