Pemetrexed

Product NDC
43547-632
11-digit product format
435470632
Labeler code
43547
Product ID
43547-632_b2088b2f-1c23-4bbf-91b3-1fc879180b8f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pemetrexed
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Solco Healthcare US, LLC
Application
ANDA216582
Marketing category
ANDA
Marketing start
2024-07-01
Substance
PEMETREXED DISODIUM HEMIPENTAHYDRATE
Active strength
100 mg/1
Pharmacologic classes
Folate Analog Metabolic Inhibitor [EPC], Folic Acid Metabolism Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Pemetrexed
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PEMETREXED DISODIUM HEMIPENTAHYDRATE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF4GSH45R4C
Rxcui1728077

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
43547-632-01Pemetrexed100 in 1 VIALINJECTION, POWDER, FOR SOLUTION1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43547-632-01EA - Each43547-632437ff9eb-0259-42cc-88cf-234c18de0c1512024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43547-632PEMETREXED INJECTION, POWDER, FOR SOLUTION [SOLCO HEALTHCARE US, LLC]1Current NDC, 1 package rows20240802_bd0ada98-3237-4465-8ba2-3a12c33116fb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1728077PEMEtrexed 100 MG InjectionPSNbd0ada98-3237-4465-8ba2-3a12c33116fb2
1728077pemetrexed 100 MG InjectionSCDbd0ada98-3237-4465-8ba2-3a12c33116fb2
1728077pemetrexed 100 MG InjectionSYbd0ada98-3237-4465-8ba2-3a12c33116fb2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
43547-632-0143547063201100 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (43547-632-01) 2024-07-01NoNoHistorical