Application 214218

Type: NDA
Sponsor: HOSPIRA INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PEMETREXED	PEMETREXED	INJECTABLE;INJECTION	100MG/4ML(25MG/ML)	Yes	No
002	PEMETREXED	PEMETREXED	INJECTABLE;INJECTION	500MG/20ML(25MG/ML)	Yes	No
003	PEMETREXED	PEMETREXED	INJECTABLE;INJECTION	1G/40ML(25MG/ML)	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N214218-001	PEMETREXED DISODIUM	PEMETREXED DISODIUM	EQ 100MG BASE/4ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-06-22
N214218-002	PEMETREXED DISODIUM	PEMETREXED DISODIUM	EQ 500MG BASE/20ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-06-22
N214218-003	PEMETREXED DISODIUM	PEMETREXED DISODIUM	EQ 1GM BASE/40ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-06-22

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 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N214218-001	PEMETREXED DISODIUM	EQ 100MG BASE/4ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-06-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214218-002	PEMETREXED DISODIUM	EQ 500MG BASE/20ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-06-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214218-003	PEMETREXED DISODIUM	EQ 1GM BASE/40ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-06-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214218-001	PEMETREXED DISODIUM	EQ 100MG BASE/4ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-06-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214218-002	PEMETREXED DISODIUM	EQ 500MG BASE/20ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-06-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214218-003	PEMETREXED DISODIUM	EQ 1GM BASE/40ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-06-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214218-001	PEMETREXED DISODIUM	EQ 100MG BASE/4ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-06-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214218-002	PEMETREXED DISODIUM	EQ 500MG BASE/20ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-06-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214218-003	PEMETREXED DISODIUM	EQ 1GM BASE/40ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-06-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214218-001	PEMETREXED DISODIUM	EQ 100MG BASE/4ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-06-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214218-002	PEMETREXED DISODIUM	EQ 500MG BASE/20ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-06-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214218-003	PEMETREXED DISODIUM	EQ 1GM BASE/40ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-06-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214218-001	PEMETREXED DISODIUM	EQ 100MG BASE/4ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-06-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214218-002	PEMETREXED DISODIUM	EQ 500MG BASE/20ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-06-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214218-003	PEMETREXED DISODIUM	EQ 1GM BASE/40ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-06-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214218-001	PEMETREXED DISODIUM	EQ 100MG BASE/4ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-06-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214218-002	PEMETREXED DISODIUM	EQ 500MG BASE/20ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-06-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214218-003	PEMETREXED DISODIUM	EQ 1GM BASE/40ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-06-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214218-001	PEMETREXED DISODIUM	EQ 100MG BASE/4ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-06-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214218-002	PEMETREXED DISODIUM	EQ 500MG BASE/20ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-06-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214218-003	PEMETREXED DISODIUM	EQ 1GM BASE/40ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-06-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214218-001	PEMETREXED DISODIUM	EQ 100MG BASE/4ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-06-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214218-002	PEMETREXED DISODIUM	EQ 500MG BASE/20ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-06-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214218-003	PEMETREXED DISODIUM	EQ 1GM BASE/40ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-06-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214218-001	PEMETREXED DISODIUM	EQ 100MG BASE/4ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-06-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214218-002	PEMETREXED DISODIUM	EQ 500MG BASE/20ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-06-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214218-003	PEMETREXED DISODIUM	EQ 1GM BASE/40ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-06-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N214218-001	PEMETREXED DISODIUM	EQ 100MG BASE/4ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-06-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N214218-002	PEMETREXED DISODIUM	EQ 500MG BASE/20ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-06-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N214218-003	PEMETREXED DISODIUM	EQ 1GM BASE/40ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-06-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214218-001	PEMETREXED DISODIUM	EQ 100MG BASE/4ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-06-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214218-002	PEMETREXED DISODIUM	EQ 500MG BASE/20ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-06-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214218-003	PEMETREXED DISODIUM	EQ 1GM BASE/40ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-06-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214218-001	PEMETREXED DISODIUM	EQ 100MG BASE/4ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-06-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214218-002	PEMETREXED DISODIUM	EQ 500MG BASE/20ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-06-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214218-003	PEMETREXED DISODIUM	EQ 1GM BASE/40ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-06-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214218-001	PEMETREXED DISODIUM	EQ 100MG BASE/4ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-06-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214218-002	PEMETREXED DISODIUM	EQ 500MG BASE/20ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-06-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214218-003	PEMETREXED DISODIUM	EQ 1GM BASE/40ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-06-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N214218-001	PEMETREXED DISODIUM	EQ 100MG BASE/4ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-06-22	`8072bd15b7f6…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PEMETREXED	PEMETREXED	Hospira, Inc.	3ae68628-7ab0-4491-b3ae-6a8330b719c8	2025-10-08	Warnings, Adverse reactions	Exact identifier application applno (NDA): 214218 application number: NDA214218 ndc (product): 0409-3532 ndc (product): 0409-1045 ndc (product): 0409-2188
PEMETREXED	PEMETREXED	Hospira, Inc.	3e087418-69ff-47fa-93c2-f28699309433	2024-07-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 214218 application number: NDA214218

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0409-1045	PEMETREXED	PEMETREXED	Hospira, Inc.	NDA	Current
0409-1045	PEMETREXED	PEMETREXED	Hospira, Inc.	NDA	Current
0409-1045	PEMETREXED	PEMETREXED	Hospira, Inc.	NDA	Current
0409-2188	PEMETREXED	PEMETREXED	Hospira, Inc.	NDA	Current
0409-2188	PEMETREXED	PEMETREXED	Hospira, Inc.	NDA	Current
0409-2188	PEMETREXED	PEMETREXED	Hospira, Inc.	NDA	Current
0409-3532	PEMETREXED	PEMETREXED	Hospira, Inc.	NDA	Current
0409-3532	PEMETREXED	PEMETREXED	Hospira, Inc.	NDA	Current
0409-3532	PEMETREXED	PEMETREXED	Hospira, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
73739	ORIG	2023-03-13
72873	ORIG	2022-12-13
66345	ORIG	2021-02-24