Pemetrexed

Product NDC: 0781-3518
11-digit product format: 007813518
Labeler code: 0781
Product ID: 0781-3518_764ab64b-c642-4314-83a9-efee79fe83a3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Pemetrexed disodium
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Sandoz Inc.
Application: NDA214657
Marketing category: NDA
Marketing start: 2022-06-08
Substance: PEMETREXED DISODIUM
Active strength: 100 mg/4mL
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 42.

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
N214657-001	PEMETREXED DISODIUM	PEMETREXED DISODIUM	EQ 100MG BASE/4ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-05-26
N214657-002	PEMETREXED DISODIUM	PEMETREXED DISODIUM	EQ 500MG BASE/20ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-05-26
N214657-003	PEMETREXED DISODIUM	PEMETREXED DISODIUM	EQ 1GM BASE/40ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-05-26

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 · 90 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N214657-001	PEMETREXED DISODIUM	EQ 100MG BASE/4ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-05-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214657-002	PEMETREXED DISODIUM	EQ 500MG BASE/20ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-05-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214657-003	PEMETREXED DISODIUM	EQ 1GM BASE/40ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-05-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N214657-001	PEMETREXED DISODIUM	EQ 100MG BASE/4ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-05-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214657-002	PEMETREXED DISODIUM	EQ 500MG BASE/20ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-05-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214657-003	PEMETREXED DISODIUM	EQ 1GM BASE/40ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-05-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214657-001	PEMETREXED DISODIUM	EQ 100MG BASE/4ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-05-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214657-002	PEMETREXED DISODIUM	EQ 500MG BASE/20ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-05-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214657-003	PEMETREXED DISODIUM	EQ 1GM BASE/40ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-05-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214657-001	PEMETREXED DISODIUM	EQ 100MG BASE/4ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-05-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214657-002	PEMETREXED DISODIUM	EQ 500MG BASE/20ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-05-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214657-003	PEMETREXED DISODIUM	EQ 1GM BASE/40ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-05-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214657-001	PEMETREXED DISODIUM	EQ 100MG BASE/4ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-05-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214657-002	PEMETREXED DISODIUM	EQ 500MG BASE/20ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-05-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214657-003	PEMETREXED DISODIUM	EQ 1GM BASE/40ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-05-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214657-001	PEMETREXED DISODIUM	EQ 100MG BASE/4ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-05-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214657-002	PEMETREXED DISODIUM	EQ 500MG BASE/20ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-05-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214657-003	PEMETREXED DISODIUM	EQ 1GM BASE/40ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-05-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214657-001	PEMETREXED DISODIUM	EQ 100MG BASE/4ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-05-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214657-002	PEMETREXED DISODIUM	EQ 500MG BASE/20ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-05-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214657-003	PEMETREXED DISODIUM	EQ 1GM BASE/40ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-05-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214657-001	PEMETREXED DISODIUM	EQ 100MG BASE/4ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-05-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214657-002	PEMETREXED DISODIUM	EQ 500MG BASE/20ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-05-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214657-003	PEMETREXED DISODIUM	EQ 1GM BASE/40ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-05-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214657-001	PEMETREXED DISODIUM	EQ 100MG BASE/4ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-05-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214657-002	PEMETREXED DISODIUM	EQ 500MG BASE/20ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-05-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214657-003	PEMETREXED DISODIUM	EQ 1GM BASE/40ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-05-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214657-001	PEMETREXED DISODIUM	EQ 100MG BASE/4ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-05-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214657-002	PEMETREXED DISODIUM	EQ 500MG BASE/20ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-05-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214657-003	PEMETREXED DISODIUM	EQ 1GM BASE/40ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-05-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N214657-001	PEMETREXED DISODIUM	EQ 100MG BASE/4ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-05-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N214657-002	PEMETREXED DISODIUM	EQ 500MG BASE/20ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-05-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N214657-003	PEMETREXED DISODIUM	EQ 1GM BASE/40ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-05-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214657-001	PEMETREXED DISODIUM	EQ 100MG BASE/4ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-05-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214657-002	PEMETREXED DISODIUM	EQ 500MG BASE/20ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-05-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214657-003	PEMETREXED DISODIUM	EQ 1GM BASE/40ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-05-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214657-001	PEMETREXED DISODIUM	EQ 100MG BASE/4ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-05-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214657-002	PEMETREXED DISODIUM	EQ 500MG BASE/20ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-05-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214657-003	PEMETREXED DISODIUM	EQ 1GM BASE/40ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-05-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214657-001	PEMETREXED DISODIUM	EQ 100MG BASE/4ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-05-26	`1e350fbaab3a…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PEMETREXED DISODIUM	100 mg/4mL

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
7ac04ab7-7f8c-46ce-ab56-a7a08cd02ab3	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
4073022c-5d5d-48f5-82ed-091ad146a4b2	Product name	1	20171211
9ffbd0ae-0bce-c086-b707-f0da5f8cd7c5	Product name	1	20150828

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0781-3518-76	Pemetrexed	1 in 1 CARTON	INJECTION, SOLUTION	1		6
0781-3518-76	Pemetrexed	4 mL in 1 VIAL	INJECTION, SOLUTION	4		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0781-3518-76	ML - Milliliter	0781-3518	ff213ecf-988a-4959-b9a3-35f7e4a49b85	1	2022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0781-3518	PEMETREXED (PEMETREXED DISODIUM) INJECTION, SOLUTION [SANDOZ INC.]	5	Current NDC, Legacy NDC, 2 package rows	20240925_7ac04ab7-7f8c-46ce-ab56-a7a08cd02ab3.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pemetrexed	PEMETREXED DISODIUM	Sandoz Inc.	7ac04ab7-7f8c-46ce-ab56-a7a08cd02ab3	2025-12-16	Warnings, Adverse reactions	Exact identifier application applno (NDA): 214657 application number: NDA214657 ndc (product): 0781-3518

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2602365	PEMEtrexed 1 GM in 40 ML Injection	PSN	7ac04ab7-7f8c-46ce-ab56-a7a08cd02ab3	6
2602366	PEMEtrexed 100 MG in 4 ML Injection	PSN	7ac04ab7-7f8c-46ce-ab56-a7a08cd02ab3	6
2602363	PEMEtrexed 500 MG in 20 ML Injection	PSN	7ac04ab7-7f8c-46ce-ab56-a7a08cd02ab3	6
2602363	20 ML pemetrexed 25 MG/ML Injection	SCD	7ac04ab7-7f8c-46ce-ab56-a7a08cd02ab3	6
2602366	4 ML pemetrexed 25 MG/ML Injection	SCD	7ac04ab7-7f8c-46ce-ab56-a7a08cd02ab3	6
2602365	40 ML pemetrexed 25 MG/ML Injection	SCD	7ac04ab7-7f8c-46ce-ab56-a7a08cd02ab3	6
2602365	pemetrexed (as monohydrate) 1 GM per 40 ML Injection	SY	7ac04ab7-7f8c-46ce-ab56-a7a08cd02ab3	6
2602366	pemetrexed (as monohydrate) 100 MG per 4 ML Injection	SY	7ac04ab7-7f8c-46ce-ab56-a7a08cd02ab3	6
2602363	pemetrexed (as monohydrate) 500 MG per 20 ML Injection	SY	7ac04ab7-7f8c-46ce-ab56-a7a08cd02ab3	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0781-3518-76	00781351876	1 VIAL in 1 CARTON (0781-3518-76) / 4 mL in 1 VIAL	1 vial	2022-06-08	0000-00-00	No	No	Current