Home NDC 71390-250 Pemfexy
Product NDC 71390-250
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 Product TE source text 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.
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.
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