FDA.reportPublic FDA data

Pemetrexed

Product NDC
67184-0503
11-digit product format
671840503
Labeler code
67184
Product ID
67184-0503_0dc735ab-c4c9-4e19-bb80-8a439be7208c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pemetrexed disodium
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Qilu Pharmaceutical Co., Ltd.
Application
ANDA204890
Marketing category
ANDA
Marketing start
2022-05-25
Substance
PEMETREXED DISODIUM HEMIPENTAHYDRATE
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 DISODIUM HEMIPENTAHYDRATE100 mg/4mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF4GSH45R4C
Rxcui1728072, 1728077

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67184-0503-12022-06-07C16284748780-19d75b9d0-0bdd-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use PEMETREXED FOR INJECTION safely and effectively. See full prescribing information for PEMETREXED FOR INJECTION. PEMETREXED for injection, for intravenous use Initial U.S. Approval: 2004
67184-0503-12020-01-31C16284748780-19d75b9d0-0bdd-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use PEMETREXED FOR INJECTION safely and effectively. See full prescribing information for PEMETREXED FOR INJECTION. PEMETREXED for injection, for intravenous use Initial U.S. Approval: 2004

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67184-0503-1Pemetrexed1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,15
67184-0503-1Pemetrexed4 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,45

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67184-0503PEMETREXED (PEMETREXED DISODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [QILU PHARMACEUTICAL CO., LTD.]5Current NDC, Legacy NDC, 2 package rows20220608_46a9b89d-7135-4e0c-b8e4-52580554769b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1728077PEMEtrexed 100 MG InjectionPSN46a9b89d-7135-4e0c-b8e4-52580554769b5
1728072PEMEtrexed 500 MG InjectionPSN46a9b89d-7135-4e0c-b8e4-52580554769b5
1728077pemetrexed 100 MG InjectionSCD46a9b89d-7135-4e0c-b8e4-52580554769b5
1728072pemetrexed 500 MG InjectionSCD46a9b89d-7135-4e0c-b8e4-52580554769b5
1728077pemetrexed 100 MG InjectionSY46a9b89d-7135-4e0c-b8e4-52580554769b5
1728072pemetrexed 500 MG InjectionSY46a9b89d-7135-4e0c-b8e4-52580554769b5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67184-0503-1671840503011 VIAL in 1 CARTON (67184-0503-1) / 4 mL in 1 VIAL1 vial2022-05-250000-00-00NoNoCurrent