Pemetrexed

Product NDC
68001-537
11-digit product format
680010537
Labeler code
68001
Product ID
68001-537_e3d6ecf2-ce3e-8347-e053-2995a90aa0bd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pemetrexed
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
BluePoint Laboratories
Application
ANDA214632
Marketing category
ANDA
Marketing start
2022-07-04
Marketing end
0000-00-00
Substance
PEMETREXED DISODIUM HEMIPENTAHYDRATE
Active strength
1000 mg/40mL
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 productproduct68001-537DDiscontinued by firm2026-08-17
excluded packagepackage68001-53768001-537-41DDiscontinued 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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68001-537-41d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68001-537-41f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68001-537-412ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68001-537-41a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68001-537-41cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68001-537-41cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68001-537-41302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68001-537-41ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68001-537-410efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68001-537-41ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68001-537-41367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68001-537-41557ba5c1ecfa…9c80585c8c6e…

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
A214632-001PEMETREXED DISODIUMPEMETREXED DISODIUMEQ 100MG BASE/VIALPOWDER / INTRAVENOUSAP2022-05-25
A214632-002PEMETREXED DISODIUMPEMETREXED DISODIUMEQ 500MG BASE/VIALPOWDER / INTRAVENOUSAP2022-05-25
A214632-003PEMETREXED DISODIUMPEMETREXED DISODIUMEQ 1GM BASE/VIALPOWDER / INTRAVENOUSAP2022-05-25

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A214632-001AP
A214632-002AP
A214632-003AP

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 · 90 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A214632-001PEMETREXED DISODIUMEQ 100MG BASE/VIALPOWDER / INTRAVENOUSAP2022-05-25caaa826d4ba7…
2026-08-18 06:07:402026-07A214632-002PEMETREXED DISODIUMEQ 500MG BASE/VIALPOWDER / INTRAVENOUSAP2022-05-25caaa826d4ba7…
2026-08-18 06:07:402026-07A214632-003PEMETREXED DISODIUMEQ 1GM BASE/VIALPOWDER / INTRAVENOUSAP2022-05-25caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A214632-001PEMETREXED DISODIUMEQ 100MG BASE/VIALPOWDER / INTRAVENOUSAP2022-05-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214632-002PEMETREXED DISODIUMEQ 500MG BASE/VIALPOWDER / INTRAVENOUSAP2022-05-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214632-003PEMETREXED DISODIUMEQ 1GM BASE/VIALPOWDER / INTRAVENOUSAP2022-05-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214632-001PEMETREXED DISODIUMEQ 100MG BASE/VIALPOWDER / INTRAVENOUSAP2022-05-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214632-002PEMETREXED DISODIUMEQ 500MG BASE/VIALPOWDER / INTRAVENOUSAP2022-05-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214632-003PEMETREXED DISODIUMEQ 1GM BASE/VIALPOWDER / INTRAVENOUSAP2022-05-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A214632-001PEMETREXED DISODIUMEQ 100MG BASE/VIALPOWDER / INTRAVENOUSAP2022-05-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214632-002PEMETREXED DISODIUMEQ 500MG BASE/VIALPOWDER / INTRAVENOUSAP2022-05-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214632-003PEMETREXED DISODIUMEQ 1GM BASE/VIALPOWDER / INTRAVENOUSAP2022-05-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214632-001PEMETREXED DISODIUMEQ 100MG BASE/VIALPOWDER / INTRAVENOUSAP2022-05-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214632-002PEMETREXED DISODIUMEQ 500MG BASE/VIALPOWDER / INTRAVENOUSAP2022-05-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214632-003PEMETREXED DISODIUMEQ 1GM BASE/VIALPOWDER / INTRAVENOUSAP2022-05-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214632-001PEMETREXED DISODIUMEQ 100MG BASE/VIALPOWDER / INTRAVENOUSAP2022-05-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214632-002PEMETREXED DISODIUMEQ 500MG BASE/VIALPOWDER / INTRAVENOUSAP2022-05-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214632-003PEMETREXED DISODIUMEQ 1GM BASE/VIALPOWDER / INTRAVENOUSAP2022-05-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214632-001PEMETREXED DISODIUMEQ 100MG BASE/VIALPOWDER / INTRAVENOUSAP2022-05-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214632-002PEMETREXED DISODIUMEQ 500MG BASE/VIALPOWDER / INTRAVENOUSAP2022-05-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214632-003PEMETREXED DISODIUMEQ 1GM BASE/VIALPOWDER / INTRAVENOUSAP2022-05-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214632-001PEMETREXED DISODIUMEQ 100MG BASE/VIALPOWDER / INTRAVENOUSAP2022-05-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214632-002PEMETREXED DISODIUMEQ 500MG BASE/VIALPOWDER / INTRAVENOUSAP2022-05-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214632-003PEMETREXED DISODIUMEQ 1GM BASE/VIALPOWDER / INTRAVENOUSAP2022-05-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214632-001PEMETREXED DISODIUMEQ 100MG BASE/VIALPOWDER / INTRAVENOUSAP2022-05-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214632-002PEMETREXED DISODIUMEQ 500MG BASE/VIALPOWDER / INTRAVENOUSAP2022-05-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214632-003PEMETREXED DISODIUMEQ 1GM BASE/VIALPOWDER / INTRAVENOUSAP2022-05-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214632-001PEMETREXED DISODIUMEQ 100MG BASE/VIALPOWDER / INTRAVENOUSAP2022-05-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214632-002PEMETREXED DISODIUMEQ 500MG BASE/VIALPOWDER / INTRAVENOUSAP2022-05-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214632-003PEMETREXED DISODIUMEQ 1GM BASE/VIALPOWDER / INTRAVENOUSAP2022-05-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214632-001PEMETREXED DISODIUMEQ 100MG BASE/VIALPOWDER / INTRAVENOUSAP2022-05-25d06236e962d9…
2024-10-29 15:01 UTC2024-10A214632-002PEMETREXED DISODIUMEQ 500MG BASE/VIALPOWDER / INTRAVENOUSAP2022-05-25d06236e962d9…
2024-10-29 15:01 UTC2024-10A214632-003PEMETREXED DISODIUMEQ 1GM BASE/VIALPOWDER / INTRAVENOUSAP2022-05-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214632-001PEMETREXED DISODIUMEQ 100MG BASE/VIALPOWDER / INTRAVENOUSAP2022-05-2579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214632-002PEMETREXED DISODIUMEQ 500MG BASE/VIALPOWDER / INTRAVENOUSAP2022-05-2579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214632-003PEMETREXED DISODIUMEQ 1GM BASE/VIALPOWDER / INTRAVENOUSAP2022-05-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214632-001PEMETREXED DISODIUMEQ 100MG BASE/VIALPOWDER / INTRAVENOUSAP2022-05-25301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214632-002PEMETREXED DISODIUMEQ 500MG BASE/VIALPOWDER / INTRAVENOUSAP2022-05-25301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214632-003PEMETREXED DISODIUMEQ 1GM BASE/VIALPOWDER / INTRAVENOUSAP2022-05-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214632-001PEMETREXED DISODIUMEQ 100MG BASE/VIALPOWDER / INTRAVENOUSAP2022-05-251e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 90 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A214632-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A214632-002AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A214632-003AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A214632-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214632-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214632-003AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214632-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214632-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214632-003AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A214632-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214632-002AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214632-003AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214632-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214632-002AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214632-003AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214632-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214632-002AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214632-003AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214632-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214632-002AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214632-003AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214632-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214632-002AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214632-003AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214632-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214632-002AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214632-003AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214632-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214632-002AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214632-003AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214632-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A214632-002AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A214632-003AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214632-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214632-002AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214632-003AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214632-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214632-002AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214632-003AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214632-001AP11e350fbaab3a…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6b7ab8f1-bb38-4c30-8b8b-003c0fe639eaProduct name120250303
0976ea44-ea26-403d-a39d-71fffc6a3d33Product name420250225
f15e8921-7cd5-4c00-9cde-9fa0c9eaca68Product name120231013
0bb393b5-af67-4798-84a7-b797956b02a5Product name120230830
7ea5dc07-b4d4-439d-8145-a10a534148e7Product name120230320
a620f3f0-1e13-41d6-a838-d5407971d39eProduct name120230313
8766e415-735a-4d2c-b173-894ecced3fd9Product name120230308
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68001-537-41Pemetrexed40 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,404
68001-537-41Pemetrexed1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68001-537PEMETREXED INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BLUEPOINT LABORATORIES]4Legacy NDC, 2 package rows20230906_495c6751-8d6f-4093-8108-9bed283fce03.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PemetrexedPEMETREXEDBluePoint Laboratories495c6751-8d6f-4093-8108-9bed283fce032023-09-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214632
application number: ANDA214632
ndc (product): 68001-537
PemetrexedPEMETREXEDEugia US LLC737ead51-f73c-414f-b68f-d3affc27a2252023-07-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214632
application number: ANDA214632

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2601728PEMEtrexed 1 GM InjectionPSN495c6751-8d6f-4093-8108-9bed283fce034
1728077PEMEtrexed 100 MG InjectionPSN495c6751-8d6f-4093-8108-9bed283fce034
1728072PEMEtrexed 500 MG InjectionPSN495c6751-8d6f-4093-8108-9bed283fce034
1728077pemetrexed 100 MG InjectionSCD495c6751-8d6f-4093-8108-9bed283fce034
2601728pemetrexed 1000 MG InjectionSCD495c6751-8d6f-4093-8108-9bed283fce034
1728072pemetrexed 500 MG InjectionSCD495c6751-8d6f-4093-8108-9bed283fce034
2601728pemetrexed (as disodium heptahydrate) 1 GM InjectionSY495c6751-8d6f-4093-8108-9bed283fce034
2601728pemetrexed (as disodium heptahydrate) 1000 MG InjectionSY495c6751-8d6f-4093-8108-9bed283fce034
1728077pemetrexed 100 MG InjectionSY495c6751-8d6f-4093-8108-9bed283fce034
1728072pemetrexed 500 MG InjectionSY495c6751-8d6f-4093-8108-9bed283fce034

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68001-537-41680010537411 VIAL in 1 CARTON (68001-537-41) > 40 mL in 1 VIAL1 vial2022-07-040000-00-00NoNoCurrent