FDA.reportPublic FDA data

Pemetrexed

Product NDC
71288-166
11-digit product format
712880166
Labeler code
71288
Product ID
71288-166_235ded9d-0115-4335-b7fb-e0d4fa85b6f6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pemetrexed disodium
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Meitheal Pharmaceuticals Inc.
Application
ANDA208696
Marketing category
ANDA
Marketing start
2022-05-25
Substance
PEMETREXED DISODIUM HEMIPENTAHYDRATE
Active strength
100 mg/10mL
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/10mL

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71288-166-10Pemetrexed1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,14
71288-166-10Pemetrexed10 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,104
71288-166-91Pemetrexed1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,14
71288-166-91Pemetrexed10 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,104
71288-166-92Pemetrexed10 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,103
71288-166-92Pemetrexed1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71288-166-10EA - Each71288-166f04be5f6-2809-4018-bace-e26aa8718c4812022-06-06
71288-166-91EA - Each71288-1665b6e49ee-e877-4615-8b64-b660c0808f4412023-05-05
71288-166-92EA - Each71288-166bdbdf1db-efee-4f0d-9408-da2086d70bd612023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71288-166PEMETREXED (PEMETREXED DISODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MEITHEAL PHARMACEUTICALS INC.]4Current NDC, Legacy NDC, 2 package rows20240423_1ceacc3e-f555-489b-8b16-2baa58b2f5a5.zip
71288-166PEMETREXED (PEMETREXED DISODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MEITHEAL PHARMACEUTICALS INC.]3Current NDC, Legacy NDC, 2 package rows20240423_5fb3a2d5-b9ec-4044-abb9-3e0d848a448e.zip
71288-166PEMETREXED (PEMETREXED DISODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MEITHEAL PHARMACEUTICALS INC.]3Current NDC, Legacy NDC, 2 package rows20240423_e0d000a3-b9d2-4fa9-9591-f7acb077481d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1728077PEMEtrexed 100 MG InjectionPSN1ceacc3e-f555-489b-8b16-2baa58b2f5a54
1728077PEMEtrexed 100 MG InjectionPSNe0d000a3-b9d2-4fa9-9591-f7acb077481d4
1728072PEMEtrexed 500 MG InjectionPSN1ceacc3e-f555-489b-8b16-2baa58b2f5a54
1728072PEMEtrexed 500 MG InjectionPSNe0d000a3-b9d2-4fa9-9591-f7acb077481d4
1728077pemetrexed 100 MG InjectionSCD1ceacc3e-f555-489b-8b16-2baa58b2f5a54
1728077pemetrexed 100 MG InjectionSCDe0d000a3-b9d2-4fa9-9591-f7acb077481d4
1728072pemetrexed 500 MG InjectionSCD1ceacc3e-f555-489b-8b16-2baa58b2f5a54
1728072pemetrexed 500 MG InjectionSCDe0d000a3-b9d2-4fa9-9591-f7acb077481d4
1728077pemetrexed 100 MG InjectionSY1ceacc3e-f555-489b-8b16-2baa58b2f5a54
1728077pemetrexed 100 MG InjectionSYe0d000a3-b9d2-4fa9-9591-f7acb077481d4
1728072pemetrexed 500 MG InjectionSYe0d000a3-b9d2-4fa9-9591-f7acb077481d4
1728072pemetrexed 500 MG InjectionSY1ceacc3e-f555-489b-8b16-2baa58b2f5a54
1728077PEMEtrexed 100 MG InjectionPSN5fb3a2d5-b9ec-4044-abb9-3e0d848a448e3
1728072PEMEtrexed 500 MG InjectionPSN5fb3a2d5-b9ec-4044-abb9-3e0d848a448e3
1728077pemetrexed 100 MG InjectionSCD5fb3a2d5-b9ec-4044-abb9-3e0d848a448e3
1728072pemetrexed 500 MG InjectionSCD5fb3a2d5-b9ec-4044-abb9-3e0d848a448e3
1728077pemetrexed 100 MG InjectionSY5fb3a2d5-b9ec-4044-abb9-3e0d848a448e3
1728072pemetrexed 500 MG InjectionSY5fb3a2d5-b9ec-4044-abb9-3e0d848a448e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71288-166-10712880166101 VIAL, SINGLE-DOSE in 1 CARTON (71288-166-10) / 10 mL in 1 VIAL, SINGLE-DOSE2022-05-250000-00-00NoNoCurrent
71288-166-91712880166911 VIAL, SINGLE-DOSE in 1 CARTON (71288-166-91) / 10 mL in 1 VIAL, SINGLE-DOSE2022-05-250000-00-00NoNoCurrent
71288-166-92712880166921 VIAL, SINGLE-DOSE in 1 CARTON (71288-166-92) / 10 mL in 1 VIAL, SINGLE-DOSE2022-05-25NoNoCurrent