PEMETREXED

Product NDC: 0409-3532
11-digit product format: 004093532
Labeler code: 0409
Product ID: 0409-3532_54cf7e63-ef81-4ced-b833-a73ad8980230
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: PEMETREXED
Dosage form: INJECTION, SOLUTION, CONCENTRATE
Route: INTRAVENOUS
Labeler: Hospira, Inc.
Application: NDA214218
Marketing category: NDA
Marketing start: 2022-06-27
Substance: PEMETREXED DISODIUM
Active strength: 1 g/40mL
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 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…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PEMETREXED DISODIUM	1 g/40mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2PKU919BA9	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2602363	Internal RxNorm lookup
2602365	Internal RxNorm lookup
2602366	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
3ae68628-7ab0-4491-b3ae-6a8330b719c8	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6b7ab8f1-bb38-4c30-8b8b-003c0fe639ea	Product name	1	20250303
0976ea44-ea26-403d-a39d-71fffc6a3d33	Product name	4	20250225
f15e8921-7cd5-4c00-9cde-9fa0c9eaca68	Product name	1	20231013
0bb393b5-af67-4798-84a7-b797956b02a5	Product name	1	20230830
7ea5dc07-b4d4-439d-8145-a10a534148e7	Product name	1	20230320
a620f3f0-1e13-41d6-a838-d5407971d39e	Product name	1	20230313
8766e415-735a-4d2c-b173-894ecced3fd9	Product name	1	20230308

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0409-3532-01	PEMETREXED	1 in 1 CARTON	INJECTION, SOLUTION, CONCENTRATE	1		5
0409-3532-01	PEMETREXED	40 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION, CONCENTRATE	40		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0409-3532-01	ML - Milliliter	0409-3532	c4842127-85b2-466a-a797-362d12ead5c0	1	2022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0409-3532	PEMETREXED INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.]	4	Current NDC, Legacy NDC, 2 package rows	20220720_3ae68628-7ab0-4491-b3ae-6a8330b719c8.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 · 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
PEMETREXED	PEMETREXED	Hospira, Inc.	3e087418-69ff-47fa-93c2-f28699309433	2024-07-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 214218 application number: NDA214218

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
2PKU919BA9	PEMETREXED DISODIUM	150399-23-8	PEMETREXED DISODIUM
04Q9AIZ7NO	PEMETREXED	137281-23-3	PEMETREXED

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2602365	PEMEtrexed 1 GM in 40 ML Injection	PSN	3ae68628-7ab0-4491-b3ae-6a8330b719c8	5
2602366	PEMEtrexed 100 MG in 4 ML Injection	PSN	3ae68628-7ab0-4491-b3ae-6a8330b719c8	5
2602363	PEMEtrexed 500 MG in 20 ML Injection	PSN	3ae68628-7ab0-4491-b3ae-6a8330b719c8	5
2602363	20 ML pemetrexed 25 MG/ML Injection	SCD	3ae68628-7ab0-4491-b3ae-6a8330b719c8	5
2602366	4 ML pemetrexed 25 MG/ML Injection	SCD	3ae68628-7ab0-4491-b3ae-6a8330b719c8	5
2602365	40 ML pemetrexed 25 MG/ML Injection	SCD	3ae68628-7ab0-4491-b3ae-6a8330b719c8	5
2602365	pemetrexed (as monohydrate) 1 GM per 40 ML Injection	SY	3ae68628-7ab0-4491-b3ae-6a8330b719c8	5
2602366	pemetrexed (as monohydrate) 100 MG per 4 ML Injection	SY	3ae68628-7ab0-4491-b3ae-6a8330b719c8	5
2602363	pemetrexed (as monohydrate) 500 MG per 20 ML Injection	SY	3ae68628-7ab0-4491-b3ae-6a8330b719c8	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0409-3532-01	00409353201	1 VIAL, SINGLE-DOSE in 1 CARTON (0409-3532-01) / 40 mL in 1 VIAL, SINGLE-DOSE	2022-06-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PEMETREXED	Hospira, Inc. \| Zydus Hospira Oncology Private Limited	2025-10-08	HUMAN PRESCRIPTION DRUG LABEL	5