Pemetrexed

Product NDC
0480-4514
11-digit product format
004804514
Labeler code
0480
Product ID
0480-4514_21155bd2-118e-4ce6-adb8-dddc69ae34c7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pemetrexed
Dosage form
SOLUTION, CONCENTRATE
Route
INTRAVENOUS
Labeler
Teva Pharmaceuticals, Inc.
Application
NDA208419
Marketing category
NDA
Marketing start
2022-05-31
Substance
PEMETREXED MONOHYDRATE
Active strength
25 mg/mL
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 MONOHYDRATE25 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii236Y2F7D9J
Rxcui2602363, 2602365, 2602366

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
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0480-4514-01Pemetrexed1 in 1 CARTONSOLUTION, CONCENTRATE111
0480-4514-01Pemetrexed20 mL in 1 VIAL, SINGLE-DOSESOLUTION, CONCENTRATE2011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0480-4514-01ML - Milliliter0480-45143f0ecf40-0056-48ad-9f12-f112c0ac496212022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0480-4514PEMETREXED SOLUTION, CONCENTRATE [TEVA PHARMACEUTICALS, INC.]11Current NDC, Legacy NDC, 2 package rows20241109_8b660f68-b770-4e0a-b2f9-25e663deecc3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2602365PEMEtrexed 1 GM in 40 ML InjectionPSN8b660f68-b770-4e0a-b2f9-25e663deecc311
2602366PEMEtrexed 100 MG in 4 ML InjectionPSN8b660f68-b770-4e0a-b2f9-25e663deecc311
2602363PEMEtrexed 500 MG in 20 ML InjectionPSN8b660f68-b770-4e0a-b2f9-25e663deecc311
260236320 ML pemetrexed 25 MG/ML InjectionSCD8b660f68-b770-4e0a-b2f9-25e663deecc311
26023664 ML pemetrexed 25 MG/ML InjectionSCD8b660f68-b770-4e0a-b2f9-25e663deecc311
260236540 ML pemetrexed 25 MG/ML InjectionSCD8b660f68-b770-4e0a-b2f9-25e663deecc311
2602365pemetrexed (as monohydrate) 1 GM per 40 ML InjectionSY8b660f68-b770-4e0a-b2f9-25e663deecc311
2602366pemetrexed (as monohydrate) 100 MG per 4 ML InjectionSY8b660f68-b770-4e0a-b2f9-25e663deecc311
2602363pemetrexed (as monohydrate) 500 MG per 20 ML InjectionSY8b660f68-b770-4e0a-b2f9-25e663deecc311

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0480-4514-01004804514011 VIAL, SINGLE-DOSE in 1 CARTON (0480-4514-01) / 20 mL in 1 VIAL, SINGLE-DOSE2022-05-310000-00-00NoNoCurrent