FDA.reportPublic FDA data

Pemetrexed

Product NDC
0781-3519
11-digit product format
007813519
Labeler code
0781
Product ID
0781-3519_764ab64b-c642-4314-83a9-efee79fe83a3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pemetrexed disodium
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Sandoz Inc.
Application
NDA214657
Marketing category
NDA
Marketing start
2022-06-08
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
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 DISODIUM500 mg/20mL

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
4073022c-5d5d-48f5-82ed-091ad146a4b2Product name120171211
9ffbd0ae-0bce-c086-b707-f0da5f8cd7c5Product name120150828

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0781-3519-90Pemetrexed20 mL in 1 VIALINJECTION, SOLUTION206
0781-3519-90Pemetrexed1 in 1 CARTONINJECTION, SOLUTION16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-3519-90ML - Milliliter0781-3519c969ca80-ae25-4436-a433-fd0d243de96b12022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-3519PEMETREXED (PEMETREXED DISODIUM) INJECTION, SOLUTION [SANDOZ INC.]5Current NDC, Legacy NDC, 2 package rows20240925_7ac04ab7-7f8c-46ce-ab56-a7a08cd02ab3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2602365PEMEtrexed 1 GM in 40 ML InjectionPSN7ac04ab7-7f8c-46ce-ab56-a7a08cd02ab36
2602366PEMEtrexed 100 MG in 4 ML InjectionPSN7ac04ab7-7f8c-46ce-ab56-a7a08cd02ab36
2602363PEMEtrexed 500 MG in 20 ML InjectionPSN7ac04ab7-7f8c-46ce-ab56-a7a08cd02ab36
260236320 ML pemetrexed 25 MG/ML InjectionSCD7ac04ab7-7f8c-46ce-ab56-a7a08cd02ab36
26023664 ML pemetrexed 25 MG/ML InjectionSCD7ac04ab7-7f8c-46ce-ab56-a7a08cd02ab36
260236540 ML pemetrexed 25 MG/ML InjectionSCD7ac04ab7-7f8c-46ce-ab56-a7a08cd02ab36
2602365pemetrexed (as monohydrate) 1 GM per 40 ML InjectionSY7ac04ab7-7f8c-46ce-ab56-a7a08cd02ab36
2602366pemetrexed (as monohydrate) 100 MG per 4 ML InjectionSY7ac04ab7-7f8c-46ce-ab56-a7a08cd02ab36
2602363pemetrexed (as monohydrate) 500 MG per 20 ML InjectionSY7ac04ab7-7f8c-46ce-ab56-a7a08cd02ab36

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0781-3519-90007813519901 VIAL in 1 CARTON (0781-3519-90) / 20 mL in 1 VIAL1 vial2022-06-080000-00-00NoNoCurrent