FDA.reportPublic FDA data

Pemetrexed

Product NDC
60505-6067
Requested package NDC
60505-6067-0
11-digit product format
605056067
Labeler code
60505
Product ID
60505-6067_77cfaf5f-90c7-60f7-61a7-f5d03bdce244
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pemetrexed disodium
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Apotex Corp
Application
ANDA209085
Marketing category
ANDA
Marketing start
2022-05-25
Marketing end
0000-00-00
Substance
PEMETREXED DISODIUM
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#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage60505-606760505-6067-0DDiscontinued by firm2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A209085-001PEMETREXED DISODIUMPEMETREXED DISODIUMEQ 1GM BASE/VIALPOWDER / INTRAVENOUSAP2022-05-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A209085-001AP

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A209085-001PEMETREXED DISODIUMEQ 1GM BASE/VIALPOWDER / INTRAVENOUSAP2022-05-25a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A209085-001AP1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PemetrexedPEMETREXED DISODIUMBluePoint Laboratories61588f3c-4c06-4c35-a000-201dd10190932023-04-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209085
application number: ANDA209085

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-6067-0EA - Each60505-6067a1556b4e-e230-4d5a-8e98-541cc2090b9712022-06-06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60505-6067-0605056067001 VIAL in 1 CARTON (60505-6067-0) > 40 mL in 1 VIAL1 vial2022-05-250000-00-00NoNoCurrent