Home NDC 60505-6068 Pemetrexed
Product NDC 60505-6068
11-digit product format 605056068
Labeler code 60505
Product ID 60505-6068_bcc07a71-41ab-e25e-aaf6-79bd6a7d5f30
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Pemetrexed disodium
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Apotex Corp
Application ANDA209851
Marketing category ANDA
Marketing start 2022-05-25
Marketing end 2026-06-30
Substance PEMETREXED DISODIUM
Active strength 750 mg/30mL
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 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# DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 60505-6068-0 Pemetrexed 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 5 60505-6068-0 Pemetrexed 30 mL in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 30 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60505-6068 PEMETREXED (PEMETREXED DISODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [APOTEX CORP] 5 Current NDC, Legacy NDC, 2 package rows 20241115_2e86f231-e0c7-2d43-2920-6c42d2469d11.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Pemetrexed PEMETREXED DISODIUM BluePoint Laboratories 14974d4e-2f01-4e02-aea2-c28b3ca0781c 2023-04-26 Warnings, Adverse reactions Exact identifier application applno (ANDA): 209851 application number: ANDA209851
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 60505-6068-0 60505606800 1 VIAL in 1 CARTON (60505-6068-0) / 30 mL in 1 VIAL 1 vial 2022-05-25 2026-06-30 No No Current