pemetrexed

Product NDC
70771-1691
11-digit product format
707711691
Labeler code
70771
Product ID
70771-1691_fc5f4aa1-92c4-444b-8e64-53708c9a67bc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
pemetrexed disodium
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Zydus Lifesciences Limited
Application
ANDA214073
Marketing category
ANDA
Marketing start
2022-05-26
Substance
PEMETREXED DISODIUM
Active strength
100 mg/4mL
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 DISODIUM100 mg/4mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2PKU919BA9
Rxcui1728072, 1728077, 2601728

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
70771-1691-1pemetrexed1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,11
70771-1691-1pemetrexed4 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,41

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1691PEMETREXED (PEMETREXED DISODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ZYDUS LIFESCIENCES LIMITED]1Current NDC, Legacy NDC, 2 package rows20220527_6986de29-b077-48ac-ad2b-0cc478f72d89.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2601728PEMEtrexed 1 GM InjectionPSN6986de29-b077-48ac-ad2b-0cc478f72d891
1728077PEMEtrexed 100 MG InjectionPSN6986de29-b077-48ac-ad2b-0cc478f72d891
1728072PEMEtrexed 500 MG InjectionPSN6986de29-b077-48ac-ad2b-0cc478f72d891
1728077pemetrexed 100 MG InjectionSCD6986de29-b077-48ac-ad2b-0cc478f72d891
2601728pemetrexed 1000 MG InjectionSCD6986de29-b077-48ac-ad2b-0cc478f72d891
1728072pemetrexed 500 MG InjectionSCD6986de29-b077-48ac-ad2b-0cc478f72d891
2601728pemetrexed (as disodium heptahydrate) 1 GM InjectionSY6986de29-b077-48ac-ad2b-0cc478f72d891
2601728pemetrexed (as disodium heptahydrate) 1000 MG InjectionSY6986de29-b077-48ac-ad2b-0cc478f72d891
1728077pemetrexed 100 MG InjectionSY6986de29-b077-48ac-ad2b-0cc478f72d891
1728072pemetrexed 500 MG InjectionSY6986de29-b077-48ac-ad2b-0cc478f72d891

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70771-1691-1707711691011 VIAL in 1 CARTON (70771-1691-1) / 4 mL in 1 VIAL1 vial2022-05-260000-00-00NoNoCurrent