Home NDC 0409-1060 Pemetrexed
Product NDC 0409-1060
11-digit product format 004091060
Labeler code 0409
Product ID 0409-1060_ecccc885-df16-4182-a36c-57da74a2d973
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Pemetrexed
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Hospira, Inc.
Application NDA208746
Marketing category NDA
Marketing start 2022-06-20
Marketing end 0000-00-00
Substance PEMETREXED TROMETHAMINE ANHYDROUS
Active strength 25 mg/mL
Pharmacologic classes Folate Analog Metabolic Inhibitor [EPC], Folic Acid Metabolism Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0409-1060-01 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0409-1060-01 f5e01cc5f278…a2eaf40c39c3…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N208746-001 PEMETREXED DITROMETHAMINE PEMETREXED DITROMETHAMINE EQ 100MG BASE/VIAL POWDER / INTRAVENOUS RLD 2022-06-10 N208746-002 PEMETREXED DITROMETHAMINE PEMETREXED DITROMETHAMINE EQ 500MG BASE/VIAL POWDER / INTRAVENOUS RLD 2022-06-10 N208746-003 PEMETREXED DITROMETHAMINE PEMETREXED DITROMETHAMINE EQ 1GM BASE/VIAL POWDER / INTRAVENOUS RLD 2022-06-10
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 3 · 87 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 N208746-001 PEMETREXED DITROMETHAMINE EQ 100MG BASE/VIAL POWDER / INTRAVENOUS RLD 2022-06-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208746-002 PEMETREXED DITROMETHAMINE EQ 500MG BASE/VIAL POWDER / INTRAVENOUS RLD 2022-06-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208746-003 PEMETREXED DITROMETHAMINE EQ 1GM BASE/VIAL POWDER / INTRAVENOUS RLD 2022-06-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N208746-001 PEMETREXED DITROMETHAMINE EQ 100MG BASE/VIAL POWDER / INTRAVENOUS RLD 2022-06-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208746-002 PEMETREXED DITROMETHAMINE EQ 500MG BASE/VIAL POWDER / INTRAVENOUS RLD 2022-06-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208746-003 PEMETREXED DITROMETHAMINE EQ 1GM BASE/VIAL POWDER / INTRAVENOUS RLD 2022-06-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208746-001 PEMETREXED DITROMETHAMINE EQ 100MG BASE/VIAL POWDER / INTRAVENOUS RLD 2022-06-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208746-002 PEMETREXED DITROMETHAMINE EQ 500MG BASE/VIAL POWDER / INTRAVENOUS RLD 2022-06-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208746-003 PEMETREXED DITROMETHAMINE EQ 1GM BASE/VIAL POWDER / INTRAVENOUS RLD 2022-06-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208746-001 PEMETREXED DITROMETHAMINE EQ 100MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-06-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208746-002 PEMETREXED DITROMETHAMINE EQ 500MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-06-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208746-003 PEMETREXED DITROMETHAMINE EQ 1GM BASE/VIAL POWDER / INTRAVENOUS RLD 2022-06-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208746-001 PEMETREXED DITROMETHAMINE EQ 100MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-06-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208746-002 PEMETREXED DITROMETHAMINE EQ 500MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-06-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208746-003 PEMETREXED DITROMETHAMINE EQ 1GM BASE/VIAL POWDER / INTRAVENOUS RLD 2022-06-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208746-001 PEMETREXED DITROMETHAMINE EQ 100MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-06-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208746-002 PEMETREXED DITROMETHAMINE EQ 500MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-06-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208746-003 PEMETREXED DITROMETHAMINE EQ 1GM BASE/VIAL POWDER / INTRAVENOUS RLD 2022-06-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208746-001 PEMETREXED DITROMETHAMINE EQ 100MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-06-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208746-002 PEMETREXED DITROMETHAMINE EQ 500MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-06-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208746-003 PEMETREXED DITROMETHAMINE EQ 1GM BASE/VIAL POWDER / INTRAVENOUS RLD 2022-06-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208746-001 PEMETREXED DITROMETHAMINE EQ 100MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-06-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208746-002 PEMETREXED DITROMETHAMINE EQ 500MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-06-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208746-003 PEMETREXED DITROMETHAMINE EQ 1GM BASE/VIAL POWDER / INTRAVENOUS RLD 2022-06-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208746-001 PEMETREXED DITROMETHAMINE EQ 100MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-06-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208746-002 PEMETREXED DITROMETHAMINE EQ 500MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-06-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208746-003 PEMETREXED DITROMETHAMINE EQ 1GM BASE/VIAL POWDER / INTRAVENOUS RLD 2022-06-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208746-001 PEMETREXED DITROMETHAMINE EQ 100MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-06-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208746-002 PEMETREXED DITROMETHAMINE EQ 500MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-06-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208746-003 PEMETREXED DITROMETHAMINE EQ 1GM BASE/VIAL POWDER / INTRAVENOUS RLD 2022-06-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N208746-001 PEMETREXED DITROMETHAMINE EQ 100MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-06-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N208746-002 PEMETREXED DITROMETHAMINE EQ 500MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-06-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N208746-003 PEMETREXED DITROMETHAMINE EQ 1GM BASE/VIAL POWDER / INTRAVENOUS RLD 2022-06-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208746-001 PEMETREXED DITROMETHAMINE EQ 100MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-06-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208746-002 PEMETREXED DITROMETHAMINE EQ 500MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-06-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208746-003 PEMETREXED DITROMETHAMINE EQ 1GM BASE/VIAL POWDER / INTRAVENOUS RLD 2022-06-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208746-001 PEMETREXED DITROMETHAMINE EQ 100MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-06-10 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208746-002 PEMETREXED DITROMETHAMINE EQ 500MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-06-10 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208746-003 PEMETREXED DITROMETHAMINE EQ 1GM BASE/VIAL POWDER / INTRAVENOUS RLD 2022-06-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N208746-001 PEMETREXED DITROMETHAMINE EQ 100MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-06-10 1e350fbaab3a…
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0409-1060 PEMETREXED INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.] 4 Legacy NDC 20220723_8cdb5b46-c003-4bf6-95c2-c7af169b3f47.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0409-1060-01 00409106001 1 VIAL, SINGLE-DOSE in 1 CARTON (0409-1060-01) > 4.2 mL in 1 VIAL, SINGLE-DOSE 2022-06-20 0000-00-00 No No Current