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 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SODIUM	METHOTREXATE SODIUM	EQ 20MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982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SODIUM	METHOTREXATE SODIUM	EQ 50MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982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SODIUM	METHOTREXATE SODIUM	EQ 2.5MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982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SODIUM	METHOTREXATE SODIUM	EQ 25MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982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SODIUM	METHOTREXATE SODIUM	EQ 100MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982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LPF	METHOTREXATE SODIUM	EQ 25MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1982-03-31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 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`
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…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Methotrexate	METHOTREXATE	Hospira, Inc.	0d63ba29-b692-41b4-87e8-351265c8273f	2025-06-10	Boxed warning, Warnings, Adverse reactions	Exact identifier ndc (package): 61703-408-41 ndc11 (package): 61703040841

Reported adverse events (FAERS/openFDA)#

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