Home NDC 72603-425 Pemetrexed
Product NDC 72603-425
11-digit product format 726030425
Labeler code 72603
Product ID 72603-425_c754c764-7f07-480c-b130-c5ce64cf0b80
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Pemetrexed disodium
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler NorthStar RxLLC
Application ANDA208696
Marketing category ANDA
Marketing start 2024-10-01
Substance PEMETREXED DISODIUM HEMIPENTAHYDRATE
Active strength 500 mg/50mL
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A208696-001 PEMETREXED DISODIUM PEMETREXED DISODIUM EQ 100MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 A208696-002 PEMETREXED DISODIUM PEMETREXED DISODIUM EQ 500MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 2 · 60 observed 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 2026-08-18 06:07:40 2026-07 A208696-001 PEMETREXED DISODIUM EQ 100MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208696-002 PEMETREXED DISODIUM EQ 500MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A208696-001 PEMETREXED DISODIUM EQ 100MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208696-002 PEMETREXED DISODIUM EQ 500MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208696-001 PEMETREXED DISODIUM EQ 100MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208696-002 PEMETREXED DISODIUM EQ 500MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208696-001 PEMETREXED DISODIUM EQ 100MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208696-002 PEMETREXED DISODIUM EQ 500MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208696-001 PEMETREXED DISODIUM EQ 100MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208696-002 PEMETREXED DISODIUM EQ 500MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208696-001 PEMETREXED DISODIUM EQ 100MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208696-002 PEMETREXED DISODIUM EQ 500MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208696-001 PEMETREXED DISODIUM EQ 100MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208696-002 PEMETREXED DISODIUM EQ 500MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208696-001 PEMETREXED DISODIUM EQ 100MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208696-002 PEMETREXED DISODIUM EQ 500MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208696-001 PEMETREXED DISODIUM EQ 100MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208696-002 PEMETREXED DISODIUM EQ 500MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208696-001 PEMETREXED DISODIUM EQ 100MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208696-002 PEMETREXED DISODIUM EQ 500MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208696-001 PEMETREXED DISODIUM EQ 100MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A208696-002 PEMETREXED DISODIUM EQ 500MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208696-001 PEMETREXED DISODIUM EQ 100MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208696-002 PEMETREXED DISODIUM EQ 500MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208696-001 PEMETREXED DISODIUM EQ 100MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208696-002 PEMETREXED DISODIUM EQ 500MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208696-001 PEMETREXED DISODIUM EQ 100MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208696-002 PEMETREXED DISODIUM EQ 500MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A208696-001 PEMETREXED DISODIUM EQ 100MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A208696-002 PEMETREXED DISODIUM EQ 500MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208696-001 PEMETREXED DISODIUM EQ 100MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208696-002 PEMETREXED DISODIUM EQ 500MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 5c6f7cd8ea54…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A208696-001 PEMETREXED DISODIUM EQ 100MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A208696-002 PEMETREXED DISODIUM EQ 500MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A208696-001 PEMETREXED DISODIUM EQ 100MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A208696-002 PEMETREXED DISODIUM EQ 500MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A208696-001 PEMETREXED DISODIUM EQ 100MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A208696-002 PEMETREXED DISODIUM EQ 500MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A208696-001 PEMETREXED DISODIUM EQ 100MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A208696-002 PEMETREXED DISODIUM EQ 500MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 a72a2bbeb626…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 60 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Pemetrexed
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PEMETREXED DISODIUM HEMIPENTAHYDRATE 500 mg/50mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination F4GSH45R4C Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1728072 Internal RxNorm lookup 1728077 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 72603-425-01 Pemetrexed 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 1 72603-425-01 Pemetrexed 50 mL in 1 VIAL, SINGLE-DOSE INJECTION, POWDER, LYOPHILIZED, 50 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72603-425 PEMETREXED (PEMETREXED DISODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [NORTHSTAR RXLLC] 1 Current NDC, 2 package rows 20241001_64f4a9ed-26ff-4bc7-bef1-4faa98b35563.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 · 4 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 72603-425-01 72603042501 1 VIAL, SINGLE-DOSE in 1 CARTON (72603-425-01) / 50 mL in 1 VIAL, SINGLE-DOSE 2024-10-01 No No Current