FDA.reportPublic FDA data

Pemetrexed

Product NDC
68001-546
11-digit product format
680010546
Labeler code
68001
Product ID
68001-546_fa3ecbbb-86e3-6fca-e053-6394a90a56d9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pemetrexed disodium
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
BluePoint Laboratories
Application
ANDA209085
Marketing category
ANDA
Marketing start
2023-02-28
Substance
PEMETREXED DISODIUM
Active strength
1000 mg/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 DISODIUM1000 mg/40mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2PKU919BA9
Rxcui2601728

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
68001-546-41Pemetrexed40 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,402
68001-546-41Pemetrexed1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-546-41EA - Each68001-546a8f0cfd1-c33c-4bbc-938b-c8ca0815d3e712023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68001-546PEMETREXED (PEMETREXED DISODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BLUEPOINT LABORATORIES]2Current NDC, 2 package rows20230427_61588f3c-4c06-4c35-a000-201dd1019093.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2601728PEMEtrexed 1 GM InjectionPSN61588f3c-4c06-4c35-a000-201dd10190932
2601728pemetrexed 1000 MG InjectionSCD61588f3c-4c06-4c35-a000-201dd10190932
2601728pemetrexed (as disodium heptahydrate) 1 GM InjectionSY61588f3c-4c06-4c35-a000-201dd10190932
2601728pemetrexed (as disodium heptahydrate) 1000 MG InjectionSY61588f3c-4c06-4c35-a000-201dd10190932

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68001-546-41680010546411 VIAL in 1 CARTON (68001-546-41) / 40 mL in 1 VIAL1 vial2023-09-01NoNoHistorical