Pemfexy

Product NDC
42367-531
11-digit product format
423670531
Labeler code
42367
Product ID
42367-531_efadeccf-c754-46aa-999e-4da07a4cd2ce
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
pemetrexed
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Eagle Pharmaceuticals, Inc.
Application
NDA209472
Marketing category
NDA
Marketing start
2022-02-01
Marketing end
2028-04-30
Substance
PEMETREXED MONOHYDRATE
Active strength
25 mg/mL
Pharmacologic classes
Folate Analog Metabolic Inhibitor [EPC], Folic Acid Metabolism Inhibitors [MoA]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Pemfexy

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PEMETREXED MONOHYDRATE25 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii236Y2F7D9J
Rxcui2590672, 2590677

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814
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
42367-531-33Pemfexy1 in 1 CARTONINJECTION115
42367-531-33Pemfexy20 mL in 1 VIALINJECTION2015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42367-531-33ML - Milliliter42367-531222bb7e5-ba0c-4837-bc80-f5922f8dd4c212021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42367-531PEMFEXY (PEMETREXED) INJECTION [EAGLE PHARMACEUTICALS, INC.]13Current NDC, Legacy NDC, 2 package rows20230516_2308f4e8-21c8-49c1-a5b8-deb8610bac6a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2590672PEMEtrexed 25 MG/ML Injectable SolutionPSN2308f4e8-21c8-49c1-a5b8-deb8610bac6a15
2590677Pemfexy 25 MG/ML Injectable SolutionPSN2308f4e8-21c8-49c1-a5b8-deb8610bac6a15
2590677pemetrexed 25 MG/ML Injectable Solution [Pemfexy]SBD2308f4e8-21c8-49c1-a5b8-deb8610bac6a15
2590672pemetrexed 25 MG/ML Injectable SolutionSCD2308f4e8-21c8-49c1-a5b8-deb8610bac6a15
2590672pemetrexed 500 MG per 20 ML Injectable SolutionSY2308f4e8-21c8-49c1-a5b8-deb8610bac6a15
2590677Pemfexy 500 MG per 20 ML Injectable SolutionSY2308f4e8-21c8-49c1-a5b8-deb8610bac6a15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42367-531-33423670531331 VIAL in 1 CARTON (42367-531-33) / 20 mL in 1 VIAL1 vial2022-02-012028-04-30NoNoCurrent