FDA.reportPublic FDA data

Pemetrexed disodium

Product NDC
43598-370
11-digit product format
435980370
Labeler code
43598
Product ID
43598-370_ad279b3e-152b-998b-a0d8-f96ecff31439
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pemetrexed disodium
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Dr. Reddys Laboratories Inc
Application
ANDA202596
Marketing category
ANDA
Marketing start
2022-05-25
Substance
PEMETREXED DISODIUM
Active strength
1 g/40mL
Pharmacologic classes
Folate Analog Metabolic Inhibitor [EPC], Folic Acid Metabolism Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Pemetrexed disodium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PEMETREXED DISODIUM1 g/40mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2PKU919BA9
Rxcui1728072, 1728077, 2601728

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
43598-370-74Pemetrexed disodium40 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,409
43598-370-74Pemetrexed disodium1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-370-74EA - Each43598-3701d49292f-3244-47ed-8a88-2a2c65002f5112022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-370PEMETREXED DISODIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [DR. REDDYS LABORATORIES INC]9Current NDC, Legacy NDC, 2 package rows20221104_1d8bcf03-e055-a274-7844-ae9a523e3c4c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2601728PEMEtrexed 1 GM InjectionPSN1d8bcf03-e055-a274-7844-ae9a523e3c4c9
1728077PEMEtrexed 100 MG InjectionPSN1d8bcf03-e055-a274-7844-ae9a523e3c4c9
1728072PEMEtrexed 500 MG InjectionPSN1d8bcf03-e055-a274-7844-ae9a523e3c4c9
1728077pemetrexed 100 MG InjectionSCD1d8bcf03-e055-a274-7844-ae9a523e3c4c9
2601728pemetrexed 1000 MG InjectionSCD1d8bcf03-e055-a274-7844-ae9a523e3c4c9
1728072pemetrexed 500 MG InjectionSCD1d8bcf03-e055-a274-7844-ae9a523e3c4c9
2601728pemetrexed (as disodium heptahydrate) 1 GM InjectionSY1d8bcf03-e055-a274-7844-ae9a523e3c4c9
2601728pemetrexed (as disodium heptahydrate) 1000 MG InjectionSY1d8bcf03-e055-a274-7844-ae9a523e3c4c9
1728077pemetrexed 100 MG InjectionSY1d8bcf03-e055-a274-7844-ae9a523e3c4c9
1728072pemetrexed 500 MG InjectionSY1d8bcf03-e055-a274-7844-ae9a523e3c4c9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43598-370-74435980370741 VIAL, SINGLE-DOSE in 1 CARTON (43598-370-74) / 40 mL in 1 VIAL, SINGLE-DOSE2022-05-250000-00-00NoNoCurrent