Home NDC 68001-545 Pemetrexed
Product NDC 68001-545
11-digit product format 680010545
Labeler code 68001
Product ID 68001-545_fa3ecbbb-86e6-6fca-e053-6394a90a56d9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Pemetrexed disodium
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler BluePoint Laboratories
Application ANDA209851
Marketing category ANDA
Marketing start 2023-02-28
Substance PEMETREXED DISODIUM
Active strength 750 mg/30mL
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A209851-001 PEMETREXED DISODIUM PEMETREXED DISODIUM EQ 750MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A209851-001 AP
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 2026-08-18 06:07:40 2026-07 A209851-001 PEMETREXED DISODIUM EQ 750MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A209851-001 PEMETREXED DISODIUM EQ 750MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209851-001 PEMETREXED DISODIUM EQ 750MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209851-001 PEMETREXED DISODIUM EQ 750MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209851-001 PEMETREXED DISODIUM EQ 750MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209851-001 PEMETREXED DISODIUM EQ 750MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209851-001 PEMETREXED DISODIUM EQ 750MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209851-001 PEMETREXED DISODIUM EQ 750MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209851-001 PEMETREXED DISODIUM EQ 750MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209851-001 PEMETREXED DISODIUM EQ 750MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209851-001 PEMETREXED DISODIUM EQ 750MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209851-001 PEMETREXED DISODIUM EQ 750MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209851-001 PEMETREXED DISODIUM EQ 750MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209851-001 PEMETREXED DISODIUM EQ 750MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A209851-001 PEMETREXED DISODIUM EQ 750MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209851-001 PEMETREXED DISODIUM EQ 750MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 5c6f7cd8ea54…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A209851-001 PEMETREXED DISODIUM EQ 750MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A209851-001 PEMETREXED DISODIUM EQ 750MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A209851-001 PEMETREXED DISODIUM EQ 750MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A209851-001 PEMETREXED DISODIUM EQ 750MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A209851-001 PEMETREXED DISODIUM EQ 750MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A209851-001 PEMETREXED DISODIUM EQ 750MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A209851-001 PEMETREXED DISODIUM EQ 750MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A209851-001 PEMETREXED DISODIUM EQ 750MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A209851-001 PEMETREXED DISODIUM EQ 750MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A209851-001 PEMETREXED DISODIUM EQ 750MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A209851-001 PEMETREXED DISODIUM EQ 750MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A209851-001 PEMETREXED DISODIUM EQ 750MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A209851-001 PEMETREXED DISODIUM EQ 750MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A209851-001 PEMETREXED DISODIUM EQ 750MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Pemetrexed
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PEMETREXED DISODIUM 750 mg/30mL
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2602136 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 68001-545-41 Pemetrexed 30 mL in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 30 2 68001-545-41 Pemetrexed 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68001-545 PEMETREXED (PEMETREXED DISODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BLUEPOINT LABORATORIES] 2 Current NDC, 2 package rows 20230427_14974d4e-2f01-4e02-aea2-c28b3ca0781c.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 68001-545-41 68001054541 1 VIAL in 1 CARTON (68001-545-41) / 30 mL in 1 VIAL 1 vial 2023-09-01 No No Current