FDA.reportPublic FDA data

pemetrexed

Product NDC
70710-1674
11-digit product format
707101674
Labeler code
70710
Product ID
70710-1674_bf1de3fa-e7f8-4beb-beeb-6272709d13f2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
pemetrexed disodium
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA214073
Marketing category
ANDA
Marketing start
2022-05-26
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
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
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
70710-1674-1pemetrexed40 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,401
70710-1674-1pemetrexed1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70710-1674-1EA - Each70710-1674e526559b-1639-467c-a8e5-880c7a72d0a912022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70710-1674PEMETREXED (PEMETREXED DISODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ZYDUS PHARMACEUTICALS USA INC.]1Current NDC, Legacy NDC, 2 package rows20220527_363665ca-db15-4123-84ac-0ae66b5f1363.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2601728PEMEtrexed 1 GM InjectionPSN363665ca-db15-4123-84ac-0ae66b5f13631
1728077PEMEtrexed 100 MG InjectionPSN363665ca-db15-4123-84ac-0ae66b5f13631
1728072PEMEtrexed 500 MG InjectionPSN363665ca-db15-4123-84ac-0ae66b5f13631
1728077pemetrexed 100 MG InjectionSCD363665ca-db15-4123-84ac-0ae66b5f13631
2601728pemetrexed 1000 MG InjectionSCD363665ca-db15-4123-84ac-0ae66b5f13631
1728072pemetrexed 500 MG InjectionSCD363665ca-db15-4123-84ac-0ae66b5f13631
2601728pemetrexed (as disodium heptahydrate) 1 GM InjectionSY363665ca-db15-4123-84ac-0ae66b5f13631
2601728pemetrexed (as disodium heptahydrate) 1000 MG InjectionSY363665ca-db15-4123-84ac-0ae66b5f13631
1728077pemetrexed 100 MG InjectionSY363665ca-db15-4123-84ac-0ae66b5f13631
1728072pemetrexed 500 MG InjectionSY363665ca-db15-4123-84ac-0ae66b5f13631

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70710-1674-1707101674011 VIAL in 1 CARTON (70710-1674-1) / 40 mL in 1 VIAL1 vial2022-05-260000-00-00NoNoCurrent