FDA.reportPublic FDA data

PEMETREXED DIPOTASSIUM

Product NDC
83831-112
11-digit product format
838310112
Labeler code
83831
Product ID
83831-112_0c1baa15-83bb-45a0-a3ab-855a4fee9129
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
pemetrexed dipotassium
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Avyxa Pharma, LLC
Application
NDA210661
Marketing category
NDA
Marketing start
2025-01-01
Substance
PEMETREXED
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 DIPOTASSIUM
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PEMETREXED500 mg/20mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii04Q9AIZ7NO
Rxcui1728072, 1728077

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
83831-112-01PEMETREXED DIPOTASSIUM20 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,206
83831-112-01PEMETREXED DIPOTASSIUM1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83831-112-01EA - Each83831-11235961074-36b5-4952-b8d4-e61b3aae687812024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83831-112PEMETREXED DIPOTASSIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [AVYXA PHARMA, LLC]6Current NDC, 2 package rows20250207_adc9ce4c-926a-4ee8-bd0d-d06fc89c17fc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1728077PEMEtrexed 100 MG InjectionPSNadc9ce4c-926a-4ee8-bd0d-d06fc89c17fc6
1728072PEMEtrexed 500 MG InjectionPSNadc9ce4c-926a-4ee8-bd0d-d06fc89c17fc6
1728077pemetrexed 100 MG InjectionSCDadc9ce4c-926a-4ee8-bd0d-d06fc89c17fc6
1728072pemetrexed 500 MG InjectionSCDadc9ce4c-926a-4ee8-bd0d-d06fc89c17fc6
1728077pemetrexed 100 MG InjectionSYadc9ce4c-926a-4ee8-bd0d-d06fc89c17fc6
1728072pemetrexed 500 MG InjectionSYadc9ce4c-926a-4ee8-bd0d-d06fc89c17fc6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83831-112-01838310112011 VIAL in 1 CARTON (83831-112-01) / 20 mL in 1 VIAL1 vial2025-01-01NoNoCurrent