FDA.reportPublic FDA data

Pemetrexed

Product NDC
63323-134
11-digit product format
633230134
Labeler code
63323
Product ID
63323-134_c7ff62a1-e697-4a7c-9907-59163f393528
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PEMETREXED DISODIUM
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
ANDA090384
Marketing category
ANDA
Marketing start
2022-05-25
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090384-001PEMETREXED DISODIUMPEMETREXED DISODIUMEQ 100MG BASE/VIALPOWDER / INTRAVENOUSAP2022-05-25
A090384-002PEMETREXED DISODIUMPEMETREXED DISODIUMEQ 500MG BASE/VIALPOWDER / INTRAVENOUSAP2022-05-25
A090384-003PEMETREXED DISODIUMPEMETREXED DISODIUMEQ 750MG BASE/VIALPOWDER / INTRAVENOUSAPRS2022-05-25
A090384-004PEMETREXED DISODIUMPEMETREXED DISODIUMEQ 1GM BASE/VIALPOWDER / INTRAVENOUSAPRS2022-05-25

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A090384-001AP
A090384-002AP
A090384-003AP
A090384-004AP

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A090384-001PEMETREXED DISODIUMEQ 100MG BASE/VIALPOWDER / INTRAVENOUSAP2022-05-25a50c72e98297…
2026-08-01 22:54:322026-06A090384-002PEMETREXED DISODIUMEQ 500MG BASE/VIALPOWDER / INTRAVENOUSAP2022-05-25a50c72e98297…
2026-08-01 22:54:322026-06A090384-003PEMETREXED DISODIUMEQ 750MG BASE/VIALPOWDER / INTRAVENOUSAPRS2022-05-25a50c72e98297…
2026-08-01 22:54:322026-06A090384-004PEMETREXED DISODIUMEQ 1GM BASE/VIALPOWDER / INTRAVENOUSAPRS2022-05-25a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A090384-001AP1a50c72e98297…
2026-08-01 22:54:322026-06A090384-002AP1a50c72e98297…
2026-08-01 22:54:322026-06A090384-003AP1a50c72e98297…
2026-08-01 22:54:322026-06A090384-004AP1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PemetrexedPEMETREXED DISODIUMFresenius Kabi USA, LLCae77f00f-d43b-4b75-afd5-a2a9cb7138da2025-08-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090384
application number: ANDA090384
ndc (product): 63323-134

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2PKU919BA9Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1728072Internal RxNorm lookup
1728077Internal RxNorm lookup
2601728Internal RxNorm lookup
2602136Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ae77f00f-d43b-4b75-afd5-a2a9cb7138daAvailable on FDA.report

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
63323-134-10Pemetrexed4 mL in 1 VIAL, SINGLE-USEINJECTION, POWDER, LYOPHILIZED,410
63323-134-10Pemetrexed1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,110

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-134-10EA - Each63323-1349304767a-b8b7-442b-97df-09d46b3c7fc512022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-134PEMETREXED (PEMETREXED DISODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC ]9Current NDC, Legacy NDC, 2 package rows20240112_ae77f00f-d43b-4b75-afd5-a2a9cb7138da.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2601728PEMEtrexed 1 GM InjectionPSNae77f00f-d43b-4b75-afd5-a2a9cb7138da10
1728077PEMEtrexed 100 MG InjectionPSNae77f00f-d43b-4b75-afd5-a2a9cb7138da10
1728072PEMEtrexed 500 MG InjectionPSNae77f00f-d43b-4b75-afd5-a2a9cb7138da10
2602136PEMEtrexed 750 MG InjectionPSNae77f00f-d43b-4b75-afd5-a2a9cb7138da10
1728077pemetrexed 100 MG InjectionSCDae77f00f-d43b-4b75-afd5-a2a9cb7138da10
2601728pemetrexed 1000 MG InjectionSCDae77f00f-d43b-4b75-afd5-a2a9cb7138da10
1728072pemetrexed 500 MG InjectionSCDae77f00f-d43b-4b75-afd5-a2a9cb7138da10
2602136pemetrexed 750 MG InjectionSCDae77f00f-d43b-4b75-afd5-a2a9cb7138da10
2601728pemetrexed (as disodium heptahydrate) 1 GM InjectionSYae77f00f-d43b-4b75-afd5-a2a9cb7138da10
2601728pemetrexed (as disodium heptahydrate) 1000 MG InjectionSYae77f00f-d43b-4b75-afd5-a2a9cb7138da10
2602136pemetrexed (as disodium heptahydrate) 750 MG InjectionSYae77f00f-d43b-4b75-afd5-a2a9cb7138da10
1728077pemetrexed 100 MG InjectionSYae77f00f-d43b-4b75-afd5-a2a9cb7138da10
1728072pemetrexed 500 MG InjectionSYae77f00f-d43b-4b75-afd5-a2a9cb7138da10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63323-134-10633230134101 VIAL, SINGLE-USE in 1 CARTON (63323-134-10) / 4 mL in 1 VIAL, SINGLE-USE2022-05-250000-00-00NoNoCurrent