FDA.reportPublic FDA data

Pemetrexed

Product NDC
31722-336
11-digit product format
317220336
Labeler code
31722
Product ID
31722-336_31b2e68a-5c70-b490-e063-6294a90aaab0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pemetrexed disodium
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA215460
Marketing category
ANDA
Marketing start
2024-06-14
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

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A215460-001PEMETREXED DISODIUMPEMETREXED DISODIUMEQ 100MG BASE/VIALPOWDER / INTRAVENOUSAP2024-06-14
A215460-002PEMETREXED DISODIUMPEMETREXED DISODIUMEQ 500MG BASE/VIALPOWDER / INTRAVENOUSAP2024-06-14

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A215460-001AP
A215460-002AP

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 22:54:322026-06A215460-001PEMETREXED DISODIUMEQ 100MG BASE/VIALPOWDER / INTRAVENOUSAP2024-06-14a50c72e98297…
2026-08-01 22:54:322026-06A215460-002PEMETREXED DISODIUMEQ 500MG BASE/VIALPOWDER / INTRAVENOUSAP2024-06-14a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A215460-001AP1a50c72e98297…
2026-08-01 22:54:322026-06A215460-002AP1a50c72e98297…

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 DISODIUMCamber Pharmaceuticals, Inc.2ca1ce75-5284-4282-b76a-3700d203c7142025-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215460
application number: ANDA215460
ndc (product): 31722-336

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
F4GSH45R4CInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2ca1ce75-5284-4282-b76a-3700d203c714Available 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
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
31722-336-31Pemetrexed4 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,41
31722-336-31Pemetrexed1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-336PEMETREXED (PEMETREXED DISODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION PEMETREXED (PEMETREXED DISODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [CAMBER PHARMACEUTICALS, INC.]1Current NDC, 2 package rows20250403_2ca1ce75-5284-4282-b76a-3700d203c714.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1728077PEMEtrexed 100 MG InjectionPSN2ca1ce75-5284-4282-b76a-3700d203c7141
1728072PEMEtrexed 500 MG InjectionPSN2ca1ce75-5284-4282-b76a-3700d203c7141
1728077pemetrexed 100 MG InjectionSCD2ca1ce75-5284-4282-b76a-3700d203c7141
1728072pemetrexed 500 MG InjectionSCD2ca1ce75-5284-4282-b76a-3700d203c7141
1728077pemetrexed 100 MG InjectionSY2ca1ce75-5284-4282-b76a-3700d203c7141
1728072pemetrexed 500 MG InjectionSY2ca1ce75-5284-4282-b76a-3700d203c7141

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
31722-336-31317220336311 VIAL in 1 CARTON (31722-336-31) / 4 mL in 1 VIAL1 vial2024-06-14NoNoCurrent