National Council for Prescription Drug Programs indexing - billing unit

Manufacturer: National Council for Prescription Drug Programs
Effective date: 2012-07-24
Label type: Indexing - Billing Unit
Version: 1
Source: full-release
Hydrated at: 2026-06-05 02:53:03

Label at a glance#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61703-408-41	ML - Milliliter	61703-408	db4ca69b-852c-4dba-aef2-9e29988f1f86	1	2012-07-24

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
61703-408	61703-408-41

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

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SODIUM	METHOTREXATE SODIUM	EQ 20MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982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SODIUM	METHOTREXATE SODIUM	EQ 50MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982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SODIUM	METHOTREXATE SODIUM	EQ 2.5MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982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SODIUM	METHOTREXATE SODIUM	EQ 25MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982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SODIUM	METHOTREXATE SODIUM	EQ 100MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982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LPF	METHOTREXATE SODIUM	EQ 25MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1982-03-31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.