Pemfexy

Product NDC: 42367-531
Requested package NDC: 42367-531-33
11-digit product format: 423670531
Labeler code: 42367
Product ID: 42367-531_efadeccf-c754-46aa-999e-4da07a4cd2ce
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: pemetrexed
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: Eagle Pharmaceuticals, Inc.
Application: NDA209472
Marketing category: NDA
Marketing start: 2022-02-01
Marketing end: 2028-04-30
Substance: PEMETREXED MONOHYDRATE
Active strength: 25 mg/mL
Pharmacologic classes: Folate Analog Metabolic Inhibitor [EPC], Folic Acid Metabolism Inhibitors [MoA]
NDC exclude flag: No
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N209472-001	PEMFEXY	PEMETREXED	500MG/20ML (25MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2020-02-08

Orange Book patents#

Current patent rows page 1 of 1 · 5 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N209472-001	9604990	2035-10-28		Drug substance	2020-07-28
N209472-001	11793813	2036-02-19		Drug product	2023-10-24
N209472-001	12115164	2036-02-19	U-4246		2025-08-25
N209472-001	12115164	2036-02-19	U-4247		2025-08-25
N209472-001	12115164	2036-02-19	U-4248		2025-08-25

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.

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	N209472-001	PEMFEXY	500MG/20ML (25MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-02-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209472-001	PEMFEXY	500MG/20ML (25MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-02-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209472-001	PEMFEXY	500MG/20ML (25MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-02-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209472-001	PEMFEXY	500MG/20ML (25MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-02-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209472-001	PEMFEXY	500MG/20ML (25MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-02-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209472-001	PEMFEXY	500MG/20ML (25MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-02-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209472-001	PEMFEXY	500MG/20ML (25MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-02-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209472-001	PEMFEXY	500MG/20ML (25MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-02-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209472-001	PEMFEXY	500MG/20ML (25MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-02-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209472-001	PEMFEXY	500MG/20ML (25MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-02-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209472-001	PEMFEXY	500MG/20ML (25MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-02-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209472-001	PEMFEXY	500MG/20ML (25MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-02-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209472-001	PEMFEXY	500MG/20ML (25MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-02-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N209472-001	PEMFEXY	500MG/20ML (25MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-02-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209472-001	PEMFEXY	500MG/20ML (25MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-02-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N209472-001	PEMFEXY	500MG/20ML (25MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-02-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N209472-001	PEMFEXY	500MG/20ML (25MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-02-08	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N209472-001	PEMFEXY	500MG/20ML (25MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-02-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N209472-001	PEMFEXY	500MG/20ML (25MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-02-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209472-001	PEMFEXY	500MG/20ML (25MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-02-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N209472-001	PEMFEXY	500MG/20ML (25MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-02-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N209472-001	PEMFEXY	500MG/20ML (25MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-02-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N209472-001	PEMFEXY	500MG/20ML (25MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-02-08	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N209472-001	PEMFEXY	500MG/20ML (25MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-02-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N209472-001	PEMFEXY	500MG/20ML (25MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-02-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N209472-001	PEMFEXY	500MG/20ML (25MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-02-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N209472-001	PEMFEXY	500MG/20ML (25MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-02-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N209472-001	PEMFEXY	500MG/20ML (25MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-02-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N209472-001	PEMFEXY	500MG/20ML (25MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-02-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N209472-001	PEMFEXY	500MG/20ML (25MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-02-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N209472-001	PEMFEXY	500MG/20ML (25MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-02-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N209472-001	PEMFEXY	500MG/20ML (25MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-02-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N209472-001	PEMFEXY	500MG/20ML (25MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-02-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N209472-001	PEMFEXY	500MG/20ML (25MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-02-08	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N209472-001	PEMFEXY	500MG/20ML (25MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-02-08	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N209472-001	PEMFEXY	500MG/20ML (25MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-02-08	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N209472-001	PEMFEXY	500MG/20ML (25MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-02-08	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 93 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N209472-001	9604990	2035-10-28		Drug substance	2020-07-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209472-001	11793813	2036-02-19		Drug product	2023-10-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209472-001	12115164	2036-02-19	U-4246		2025-08-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209472-001	12115164	2036-02-19	U-4247		2025-08-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209472-001	12115164	2036-02-19	U-4248		2025-08-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209472-001	9604990	2035-10-28		Drug substance	2020-07-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209472-001	11793813	2036-02-19		Drug product	2023-10-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209472-001	12115164	2036-02-19	U-4246		2025-08-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209472-001	12115164	2036-02-19	U-4247		2025-08-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209472-001	12115164	2036-02-19	U-4248		2025-08-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209472-001	9604990	2035-10-28		Drug substance	2020-07-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209472-001	11793813	2036-02-19		Drug product	2023-10-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209472-001	9604990	2035-10-28		Drug substance	2020-07-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209472-001	11793813	2036-02-19		Drug product	2023-10-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209472-001	9604990	2035-10-28		Drug substance	2020-07-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209472-001	11793813	2036-02-19		Drug product	2023-10-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209472-001	9604990	2035-10-28		Drug substance	2020-07-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209472-001	11793813	2036-02-19		Drug product	2023-10-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209472-001	9604990	2035-10-28		Drug substance	2020-07-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209472-001	11793813	2036-02-19		Drug product	2023-10-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209472-001	9604990	2035-10-28		Drug substance	2020-07-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209472-001	11793813	2036-02-19		Drug product	2023-10-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209472-001	9604990	2035-10-28		Drug substance	2020-07-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209472-001	11793813	2036-02-19		Drug product	2023-10-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209472-001	9604990	2035-10-28		Drug substance	2020-07-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N209472-001	11793813	2036-02-19		Drug product	2023-10-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209472-001	9604990	2035-10-28		Drug substance	2020-07-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209472-001	11793813	2036-02-19		Drug product	2023-10-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209472-001	9604990	2035-10-28		Drug substance	2020-07-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209472-001	11793813	2036-02-19		Drug product	2023-10-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209472-001	9604990	2035-10-28		Drug substance	2020-07-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209472-001	11793813	2036-02-19		Drug product	2023-10-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N209472-001	9604990	2035-10-28		Drug substance	2020-07-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N209472-001	11793813	2036-02-19		Drug product	2023-10-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209472-001	7772209	2022-05-24	U-2729		2020-02-10	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209472-001	7772209	2022-05-24	U-2728		2020-02-10	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209472-001	9604990	2035-10-28		Drug substance	2020-07-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N209472-001	7772209	2022-05-24	U-2729		2020-02-10	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N209472-001	7772209	2022-05-24	U-2728		2020-02-10	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N209472-001	9604990	2035-10-28		Drug substance	2020-07-28	`5d02ea3f76ae…`

Additional Listing Data#

Finished product: Yes
Brand name base: Pemfexy

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PEMETREXED MONOHYDRATE	25 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
236Y2F7D9J	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2590672	Internal RxNorm lookup
2590677	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
2308f4e8-21c8-49c1-a5b8-deb8610bac6a	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75	Product name	2	20250814
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
42367-531-33	Pemfexy	1 in 1 CARTON	INJECTION	1		15
42367-531-33	Pemfexy	20 mL in 1 VIAL	INJECTION	20		15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42367-531-33	ML - Milliliter	42367-531	222bb7e5-ba0c-4837-bc80-f5922f8dd4c2	1	2021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42367-531	PEMFEXY (PEMETREXED) INJECTION [EAGLE PHARMACEUTICALS, INC.]	13	Current NDC, Legacy NDC, 2 package rows	20230516_2308f4e8-21c8-49c1-a5b8-deb8610bac6a.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
Pemfexy	PEMETREXED	Acacia Pharma, Ltd.	caef07ce-066b-4c48-98dc-974b05ebbbe0	2026-06-18	Warnings, Adverse reactions	Exact identifier application applno (NDA): 209472 application number: NDA209472
Pemfexy	PEMETREXED	Eagle Pharmaceuticals, Inc.	2308f4e8-21c8-49c1-a5b8-deb8610bac6a	2026-02-20	Warnings, Adverse reactions	Exact identifier application applno (NDA): 209472 application number: NDA209472 ndc (package): 42367-531-33 ndc (product): 42367-531 ndc11 (package): 42367053133

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
236Y2F7D9J	PEMETREXED MONOHYDRATE		PEMETREXED MONOHYDRATE
04Q9AIZ7NO	PEMETREXED	137281-23-3	pemetrexed

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2590672	PEMEtrexed 25 MG/ML Injectable Solution	PSN	2308f4e8-21c8-49c1-a5b8-deb8610bac6a	15
2590677	Pemfexy 25 MG/ML Injectable Solution	PSN	2308f4e8-21c8-49c1-a5b8-deb8610bac6a	15
2590677	pemetrexed 25 MG/ML Injectable Solution [Pemfexy]	SBD	2308f4e8-21c8-49c1-a5b8-deb8610bac6a	15
2590672	pemetrexed 25 MG/ML Injectable Solution	SCD	2308f4e8-21c8-49c1-a5b8-deb8610bac6a	15
2590672	pemetrexed 500 MG per 20 ML Injectable Solution	SY	2308f4e8-21c8-49c1-a5b8-deb8610bac6a	15
2590677	Pemfexy 500 MG per 20 ML Injectable Solution	SY	2308f4e8-21c8-49c1-a5b8-deb8610bac6a	15

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
42367-531-33	42367053133	1 VIAL in 1 CARTON (42367-531-33) / 20 mL in 1 VIAL	1 vial	2022-02-01	2028-04-30	No	No	Current