Pemetrexed

Product NDC
0409-1061
11-digit product format
004091061
Labeler code
0409
Product ID
0409-1061_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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0409-1061DDiscontinued by firm2026-08-17
excluded packagepackage0409-10610409-1061-01DDiscontinued by firm2026-08-17

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 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproduct0409-1061DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0409-10610409-1061-01DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N208746-001PEMETREXED DITROMETHAMINEPEMETREXED DITROMETHAMINEEQ 100MG BASE/VIALPOWDER / INTRAVENOUSRLD2022-06-10
N208746-002PEMETREXED DITROMETHAMINEPEMETREXED DITROMETHAMINEEQ 500MG BASE/VIALPOWDER / INTRAVENOUSRLD2022-06-10
N208746-003PEMETREXED DITROMETHAMINEPEMETREXED DITROMETHAMINEEQ 1GM BASE/VIALPOWDER / INTRAVENOUSRLD2022-06-10

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N208746-001PEMETREXED DITROMETHAMINEEQ 100MG BASE/VIALPOWDER / INTRAVENOUSRLD2022-06-10caaa826d4ba7…
2026-08-18 06:07:402026-07N208746-002PEMETREXED DITROMETHAMINEEQ 500MG BASE/VIALPOWDER / INTRAVENOUSRLD2022-06-10caaa826d4ba7…
2026-08-18 06:07:402026-07N208746-003PEMETREXED DITROMETHAMINEEQ 1GM BASE/VIALPOWDER / INTRAVENOUSRLD2022-06-10caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N208746-001PEMETREXED DITROMETHAMINEEQ 100MG BASE/VIALPOWDER / INTRAVENOUSRLD2022-06-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208746-002PEMETREXED DITROMETHAMINEEQ 500MG BASE/VIALPOWDER / INTRAVENOUSRLD2022-06-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208746-003PEMETREXED DITROMETHAMINEEQ 1GM BASE/VIALPOWDER / INTRAVENOUSRLD2022-06-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208746-001PEMETREXED DITROMETHAMINEEQ 100MG BASE/VIALPOWDER / INTRAVENOUSRLD2022-06-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208746-002PEMETREXED DITROMETHAMINEEQ 500MG BASE/VIALPOWDER / INTRAVENOUSRLD2022-06-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208746-003PEMETREXED DITROMETHAMINEEQ 1GM BASE/VIALPOWDER / INTRAVENOUSRLD2022-06-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08N208746-001PEMETREXED DITROMETHAMINEEQ 100MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2022-06-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08N208746-002PEMETREXED DITROMETHAMINEEQ 500MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2022-06-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08N208746-003PEMETREXED DITROMETHAMINEEQ 1GM BASE/VIALPOWDER / INTRAVENOUSRLD2022-06-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208746-001PEMETREXED DITROMETHAMINEEQ 100MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2022-06-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208746-002PEMETREXED DITROMETHAMINEEQ 500MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2022-06-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208746-003PEMETREXED DITROMETHAMINEEQ 1GM BASE/VIALPOWDER / INTRAVENOUSRLD2022-06-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N208746-001PEMETREXED DITROMETHAMINEEQ 100MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2022-06-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N208746-002PEMETREXED DITROMETHAMINEEQ 500MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2022-06-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N208746-003PEMETREXED DITROMETHAMINEEQ 1GM BASE/VIALPOWDER / INTRAVENOUSRLD2022-06-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N208746-001PEMETREXED DITROMETHAMINEEQ 100MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2022-06-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N208746-002PEMETREXED DITROMETHAMINEEQ 500MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2022-06-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N208746-003PEMETREXED DITROMETHAMINEEQ 1GM BASE/VIALPOWDER / INTRAVENOUSRLD2022-06-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N208746-001PEMETREXED DITROMETHAMINEEQ 100MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2022-06-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N208746-002PEMETREXED DITROMETHAMINEEQ 500MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2022-06-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N208746-003PEMETREXED DITROMETHAMINEEQ 1GM BASE/VIALPOWDER / INTRAVENOUSRLD2022-06-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N208746-001PEMETREXED DITROMETHAMINEEQ 100MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2022-06-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N208746-002PEMETREXED DITROMETHAMINEEQ 500MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2022-06-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N208746-003PEMETREXED DITROMETHAMINEEQ 1GM BASE/VIALPOWDER / INTRAVENOUSRLD2022-06-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N208746-001PEMETREXED DITROMETHAMINEEQ 100MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2022-06-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N208746-002PEMETREXED DITROMETHAMINEEQ 500MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2022-06-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N208746-003PEMETREXED DITROMETHAMINEEQ 1GM BASE/VIALPOWDER / INTRAVENOUSRLD2022-06-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N208746-001PEMETREXED DITROMETHAMINEEQ 100MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2022-06-10d06236e962d9…
2024-10-29 15:01 UTC2024-10N208746-002PEMETREXED DITROMETHAMINEEQ 500MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2022-06-10d06236e962d9…
2024-10-29 15:01 UTC2024-10N208746-003PEMETREXED DITROMETHAMINEEQ 1GM BASE/VIALPOWDER / INTRAVENOUSRLD2022-06-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N208746-001PEMETREXED DITROMETHAMINEEQ 100MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2022-06-1079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N208746-002PEMETREXED DITROMETHAMINEEQ 500MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2022-06-1079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N208746-003PEMETREXED DITROMETHAMINEEQ 1GM BASE/VIALPOWDER / INTRAVENOUSRLD2022-06-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N208746-001PEMETREXED DITROMETHAMINEEQ 100MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2022-06-10301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N208746-002PEMETREXED DITROMETHAMINEEQ 500MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2022-06-10301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N208746-003PEMETREXED DITROMETHAMINEEQ 1GM BASE/VIALPOWDER / INTRAVENOUSRLD2022-06-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N208746-001PEMETREXED DITROMETHAMINEEQ 100MG BASE/VIALPOWDER / INTRAVENOUSRLD, RS2022-06-101e350fbaab3a…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-1061-01EA - Each0409-106126691ddf-4e01-44f3-94c1-729c6c4d4a5612022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-1061PEMETREXED INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.]4Legacy NDC20220723_8cdb5b46-c003-4bf6-95c2-c7af169b3f47.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0409-1061-01004091061011 VIAL, SINGLE-DOSE in 1 CARTON (0409-1061-01) > 20 mL in 1 VIAL, SINGLE-DOSE2022-06-200000-00-00NoNoCurrent