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

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A214073-001PEMETREXED DISODIUMPEMETREXED DISODIUMEQ 100MG BASE/VIALPOWDER / INTRAVENOUSAP2022-05-25
A214073-002PEMETREXED DISODIUMPEMETREXED DISODIUMEQ 500MG BASE/VIALPOWDER / INTRAVENOUSAP2022-05-25
A214073-003PEMETREXED DISODIUMPEMETREXED DISODIUMEQ 1GM BASE/VIALPOWDER / INTRAVENOUSAP2022-05-25

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A214073-001AP
A214073-002AP
A214073-003AP

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 22:54:322026-06A214073-001PEMETREXED DISODIUMEQ 100MG BASE/VIALPOWDER / INTRAVENOUSAP2022-05-25a50c72e98297…
2026-08-01 22:54:322026-06A214073-002PEMETREXED DISODIUMEQ 500MG BASE/VIALPOWDER / INTRAVENOUSAP2022-05-25a50c72e98297…
2026-08-01 22:54:322026-06A214073-003PEMETREXED DISODIUMEQ 1GM BASE/VIALPOWDER / INTRAVENOUSAP2022-05-25a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A214073-001AP1a50c72e98297…
2026-08-01 22:54:322026-06A214073-002AP1a50c72e98297…
2026-08-01 22:54:322026-06A214073-003AP1a50c72e98297…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
pemetrexedPEMETREXED DISODIUMZydus Pharmaceuticals USA Inc.363665ca-db15-4123-84ac-0ae66b5f13632022-05-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214073
application number: ANDA214073
ndc (product): 70710-1674
pemetrexedPEMETREXED DISODIUMZydus Lifesciences Limited6986de29-b077-48ac-ad2b-0cc478f72d892022-05-26Exact identifier
application applno (ANDA): 214073
application number: ANDA214073

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 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 · 3 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
363665ca-db15-4123-84ac-0ae66b5f1363Available 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
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