FDA.reportPublic FDA data

Pemetrexed

Product NDC
60505-6068
11-digit product format
605056068
Labeler code
60505
Product ID
60505-6068_bcc07a71-41ab-e25e-aaf6-79bd6a7d5f30
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pemetrexed disodium
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Apotex Corp
Application
ANDA209851
Marketing category
ANDA
Marketing start
2022-05-25
Marketing end
2026-06-30
Substance
PEMETREXED DISODIUM
Active strength
750 mg/30mL
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
Pemetrexed

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PEMETREXED DISODIUM750 mg/30mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2PKU919BA9
Rxcui2602136

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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60505-6068-0Pemetrexed1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,15
60505-6068-0Pemetrexed30 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,305

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-6068-0EA - Each60505-6068c16410d1-b0f1-489d-968c-54348315a5a412022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-6068PEMETREXED (PEMETREXED DISODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [APOTEX CORP]5Current NDC, Legacy NDC, 2 package rows20241115_2e86f231-e0c7-2d43-2920-6c42d2469d11.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2602136PEMEtrexed 750 MG InjectionPSN2e86f231-e0c7-2d43-2920-6c42d2469d115
2602136pemetrexed 750 MG InjectionSCD2e86f231-e0c7-2d43-2920-6c42d2469d115
2602136pemetrexed (as disodium heptahydrate) 750 MG InjectionSY2e86f231-e0c7-2d43-2920-6c42d2469d115

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60505-6068-0605056068001 VIAL in 1 CARTON (60505-6068-0) / 30 mL in 1 VIAL1 vial2022-05-252026-06-30NoNoCurrent