FDA.reportPublic FDA data

PEMETREXED

Product NDC
0409-0004
11-digit product format
004090004
Labeler code
0409
Product ID
0409-0004_b61d5060-31ca-4067-8e5c-d31e76c6390d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PEMETREXED
Dosage form
INJECTION, SOLUTION, CONCENTRATE
Route
INTRAVENOUS
Labeler
Hospira, Inc.
Application
NDA214218
Marketing category
NDA
Marketing start
2023-02-01
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PEMETREXED DISODIUM1 g/40mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2PKU919BA9
Rxcui2602363, 2602365, 2602366

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0409-0004-04PEMETREXED40 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION, CONCENTRATE402
0409-0004-04PEMETREXED1 in 1 CARTONINJECTION, SOLUTION, CONCENTRATE12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-0004PEMETREXED INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.]2Current NDC, 2 package rows20240725_3e087418-69ff-47fa-93c2-f28699309433.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2602365PEMEtrexed 1 GM in 40 ML InjectionPSN3e087418-69ff-47fa-93c2-f286993094332
2602366PEMEtrexed 100 MG in 4 ML InjectionPSN3e087418-69ff-47fa-93c2-f286993094332
2602363PEMEtrexed 500 MG in 20 ML InjectionPSN3e087418-69ff-47fa-93c2-f286993094332
260236320 ML pemetrexed 25 MG/ML InjectionSCD3e087418-69ff-47fa-93c2-f286993094332
26023664 ML pemetrexed 25 MG/ML InjectionSCD3e087418-69ff-47fa-93c2-f286993094332
260236540 ML pemetrexed 25 MG/ML InjectionSCD3e087418-69ff-47fa-93c2-f286993094332
2602365pemetrexed (as monohydrate) 1 GM per 40 ML InjectionSY3e087418-69ff-47fa-93c2-f286993094332
2602366pemetrexed (as monohydrate) 100 MG per 4 ML InjectionSY3e087418-69ff-47fa-93c2-f286993094332
2602363pemetrexed (as monohydrate) 500 MG per 20 ML InjectionSY3e087418-69ff-47fa-93c2-f286993094332

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0409-0004-04004090004041 VIAL, SINGLE-DOSE in 1 CARTON (0409-0004-04) / 40 mL in 1 VIAL, SINGLE-DOSE2023-02-01NoNoCurrent