Pemfexy

Product NDC: 71390-250
Requested package NDC: 71390-250-02
11-digit product format: 713900250
Labeler code: 71390
Product ID: 71390-250_49baf2a0-c1bf-49a8-a2f9-176cae0b7410
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: pemetrexed
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: Acacia Pharma, Ltd.
Application: NDA209472
Marketing category: NDA
Marketing start: 2026-06-22
Substance: PEMETREXED MONOHYDRATE
Active strength: 25 mg/mL
Pharmacologic classes: Folate Analog Metabolic Inhibitor [EPC], Folic Acid Metabolism Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
2026-09-14 22:38:34	2026-08	N209472-001	PEMFEXY	500MG/20ML (25MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-02-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N209472-001	PEMFEXY	500MG/20ML (25MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-02-08	`caaa826d4ba7…`
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 · 103 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N209472-001	9604990	2035-10-28		Drug substance	2020-07-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209472-001	11793813	2036-02-19		Drug product	2023-10-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209472-001	12115164	2036-02-19	U-4246		2025-08-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209472-001	12115164	2036-02-19	U-4247		2025-08-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209472-001	12115164	2036-02-19	U-4248		2025-08-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N209472-001	9604990	2035-10-28		Drug substance	2020-07-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209472-001	11793813	2036-02-19		Drug product	2023-10-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209472-001	12115164	2036-02-19	U-4246		2025-08-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209472-001	12115164	2036-02-19	U-4247		2025-08-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209472-001	12115164	2036-02-19	U-4248		2025-08-25	`caaa826d4ba7…`
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…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Pemfexy
Listing expiration: 2027-12-31

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
caef07ce-066b-4c48-98dc-974b05ebbbe0	Available on FDA.report

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 ndc (package): 71390-250-02 ndc (product): 71390-250 ndc11 (package): 71390025002
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

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
71390-250-02	71390025002	1 VIAL in 1 CARTON (71390-250-02) / 20 mL in 1 VIAL	1 vial	2026-06-22	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Pemfexy	Acacia Pharma, Ltd. \| Eagle Pharmaceuticals, Inc.	2026-06-18	HUMAN PRESCRIPTION DRUG LABEL	2