FDA.reportPublic FDA data

Pemetrexed disodium

Product NDC
70121-1233
Requested package NDC
70121-1233-1
11-digit product format
701211233
Labeler code
70121
Product ID
70121-1233_d7475c11-64bf-4c22-85ba-704e874bde69
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pemetrexed
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA210047
Marketing category
ANDA
Marketing start
2022-08-10
Marketing end
0000-00-00
Substance
PEMETREXED DISODIUM
Active strength
500 mg/20mL
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 packagepackage70121-123370121-1233-1DDiscontinued 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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A210047-001PEMETREXED DISODIUMPEMETREXED DISODIUMEQ 500MG BASE/VIALPOWDER / INTRAVENOUS2022-08-04
A210047-002PEMETREXED DISODIUMPEMETREXED DISODIUMEQ 100MG BASE/VIALPOWDER / INTRAVENOUS2023-05-08

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 22:54:322026-06A210047-001PEMETREXED DISODIUMEQ 500MG BASE/VIALPOWDER / INTRAVENOUS2022-08-04a50c72e98297…
2026-08-01 22:54:322026-06A210047-002PEMETREXED DISODIUMEQ 100MG BASE/VIALPOWDER / INTRAVENOUS2023-05-08a50c72e98297…

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70121-1233PEMETREXED DISODIUM (PEMETREXED) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [AMNEAL PHARMACEUTICALS LLC]10Legacy NDC20230517_e4a92d35-a0ac-486e-94a7-289ede47af46.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70121-1233-1701211233011 VIAL, SINGLE-DOSE in 1 CARTON (70121-1233-1) > 20 mL in 1 VIAL, SINGLE-DOSE2022-08-100000-00-00NoNoCurrent