Pemetrexed for injection, for Intravenous Use

Manufacturer
Zydus Lifesciences Limited | Zydus Hospira Oncology Private Limited
Effective date
2022-05-26
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 20:41:41

Label at a glance#

Productpemetrexed
Active ingredientPEMETREXED DISODIUM
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1691-1

Pemetrexed for Injection, USP

100 mg/vial

For intravenous use only.

Single-Dose Vial

Rx only

100 mg vial label
100 mg vial label

NDC 70771-1691-1

Pemetrexed for Injection, USP

100 mg/vial

For intravenous use only.

One Single-Dose Vial Carton

Rx only

100 mg carton label
100 mg carton label

NDC 70771-1692-1

Pemetrexed for Injection, USP

500 mg/vial

For intravenous use only.

Single-Dose Vial

Rx only

500 mg vial label
500 mg vial label

NDC 70771-1692-1

Pemetrexed for Injection, USP

500 mg/vial

For intravenous use only.

One Single-Dose Vial Carton

Rx only

500 mg carton label
500 mg carton label

NDC 70771-1693-1

Pemetrexed for Injection, USP

1000 mg/vial

For intravenous use only.

Single-Dose Vial

Rx only

1,000 mg vial label
1,000 mg vial label

NDC 70771-1693-1

Pemetrexed for Injection, USP

1000 mg/vial

For intravenous use only.

One Single-Dose Vial Carton

Rx only

1,000 mg carton label
1,000 mg carton label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2601728PEMEtrexed 1 GM InjectionPSN1
1728077PEMEtrexed 100 MG InjectionPSN1
1728072PEMEtrexed 500 MG InjectionPSN1
1728077pemetrexed 100 MG InjectionSCD1
2601728pemetrexed 1000 MG InjectionSCD1
1728072pemetrexed 500 MG InjectionSCD1
2601728pemetrexed (as disodium heptahydrate) 1 GM InjectionSY1
2601728pemetrexed (as disodium heptahydrate) 1000 MG InjectionSY1
1728077pemetrexed 100 MG InjectionSY1
1728072pemetrexed 500 MG InjectionSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
PEMETREXED Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

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
70771-1691-1pemetrexed1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,11
70771-1691-1pemetrexed4 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,41
70771-1692-1pemetrexed20 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,201
70771-1692-1pemetrexed1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,11
70771-1693-1pemetrexed1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,11
70771-1693-1pemetrexed40 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,401

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1691PEMETREXED (PEMETREXED DISODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ZYDUS LIFESCIENCES LIMITED]1Current NDC, Legacy NDC, 2 package rows20220527_6986de29-b077-48ac-ad2b-0cc478f72d89.zip
70771-1692PEMETREXED (PEMETREXED DISODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ZYDUS LIFESCIENCES LIMITED]1Current NDC, Legacy NDC, 2 package rows20220527_6986de29-b077-48ac-ad2b-0cc478f72d89.zip
70771-1693PEMETREXED (PEMETREXED DISODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ZYDUS LIFESCIENCES LIMITED]1Current NDC, Legacy NDC, 2 package rows20220527_6986de29-b077-48ac-ad2b-0cc478f72d89.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70771-169170771-1691-1
70771-169270771-1692-1
70771-169370771-1693-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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.

Product history page 1 of 3 · 96 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A214073-001PEMETREXED DISODIUMEQ 100MG BASE/VIALPOWDER / INTRAVENOUSAP2022-05-25c2088c7a36db…
2026-10-15 13:18:302026-09A214073-002PEMETREXED DISODIUMEQ 500MG BASE/VIALPOWDER / INTRAVENOUSAP2022-05-25c2088c7a36db…
2026-10-15 13:18:302026-09A214073-003PEMETREXED DISODIUMEQ 1GM BASE/VIALPOWDER / INTRAVENOUSAP2022-05-25c2088c7a36db…
2026-09-14 22:38:342026-08A214073-001PEMETREXED DISODIUMEQ 100MG BASE/VIALPOWDER / INTRAVENOUSAP2022-05-2584e616aacf4f…
2026-09-14 22:38:342026-08A214073-002PEMETREXED DISODIUMEQ 500MG BASE/VIALPOWDER / INTRAVENOUSAP2022-05-2584e616aacf4f…
2026-09-14 22:38:342026-08A214073-003PEMETREXED DISODIUMEQ 1GM BASE/VIALPOWDER / INTRAVENOUSAP2022-05-2584e616aacf4f…
2026-08-18 06:07:402026-07A214073-001PEMETREXED DISODIUMEQ 100MG BASE/VIALPOWDER / INTRAVENOUSAP2022-05-25caaa826d4ba7…
2026-08-18 06:07:402026-07A214073-002PEMETREXED DISODIUMEQ 500MG BASE/VIALPOWDER / INTRAVENOUSAP2022-05-25caaa826d4ba7…
2026-08-18 06:07:402026-07A214073-003PEMETREXED DISODIUMEQ 1GM BASE/VIALPOWDER / INTRAVENOUSAP2022-05-25caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A214073-001PEMETREXED DISODIUMEQ 100MG BASE/VIALPOWDER / INTRAVENOUSAP2022-05-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214073-002PEMETREXED DISODIUMEQ 500MG BASE/VIALPOWDER / INTRAVENOUSAP2022-05-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214073-003PEMETREXED DISODIUMEQ 1GM BASE/VIALPOWDER / INTRAVENOUSAP2022-05-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214073-001PEMETREXED DISODIUMEQ 100MG BASE/VIALPOWDER / INTRAVENOUSAP2022-05-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214073-002PEMETREXED DISODIUMEQ 500MG BASE/VIALPOWDER / INTRAVENOUSAP2022-05-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214073-003PEMETREXED DISODIUMEQ 1GM BASE/VIALPOWDER / INTRAVENOUSAP2022-05-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A214073-001PEMETREXED DISODIUMEQ 100MG BASE/VIALPOWDER / INTRAVENOUSAP2022-05-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214073-002PEMETREXED DISODIUMEQ 500MG BASE/VIALPOWDER / INTRAVENOUSAP2022-05-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214073-003PEMETREXED DISODIUMEQ 1GM BASE/VIALPOWDER / INTRAVENOUSAP2022-05-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214073-001PEMETREXED DISODIUMEQ 100MG BASE/VIALPOWDER / INTRAVENOUSAP2022-05-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214073-002PEMETREXED DISODIUMEQ 500MG BASE/VIALPOWDER / INTRAVENOUSAP2022-05-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214073-003PEMETREXED DISODIUMEQ 1GM BASE/VIALPOWDER / INTRAVENOUSAP2022-05-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214073-001PEMETREXED DISODIUMEQ 100MG BASE/VIALPOWDER / INTRAVENOUSAP2022-05-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214073-002PEMETREXED DISODIUMEQ 500MG BASE/VIALPOWDER / INTRAVENOUSAP2022-05-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214073-003PEMETREXED DISODIUMEQ 1GM BASE/VIALPOWDER / INTRAVENOUSAP2022-05-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214073-001PEMETREXED DISODIUMEQ 100MG BASE/VIALPOWDER / INTRAVENOUSAP2022-05-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214073-002PEMETREXED DISODIUMEQ 500MG BASE/VIALPOWDER / INTRAVENOUSAP2022-05-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214073-003PEMETREXED DISODIUMEQ 1GM BASE/VIALPOWDER / INTRAVENOUSAP2022-05-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214073-001PEMETREXED DISODIUMEQ 100MG BASE/VIALPOWDER / INTRAVENOUSAP2022-05-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214073-002PEMETREXED DISODIUMEQ 500MG BASE/VIALPOWDER / INTRAVENOUSAP2022-05-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214073-003PEMETREXED DISODIUMEQ 1GM BASE/VIALPOWDER / INTRAVENOUSAP2022-05-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214073-001PEMETREXED DISODIUMEQ 100MG BASE/VIALPOWDER / INTRAVENOUSAP2022-05-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214073-002PEMETREXED DISODIUMEQ 500MG BASE/VIALPOWDER / INTRAVENOUSAP2022-05-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214073-003PEMETREXED DISODIUMEQ 1GM BASE/VIALPOWDER / INTRAVENOUSAP2022-05-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214073-001PEMETREXED DISODIUMEQ 100MG BASE/VIALPOWDER / INTRAVENOUSAP2022-05-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214073-002PEMETREXED DISODIUMEQ 500MG BASE/VIALPOWDER / INTRAVENOUSAP2022-05-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214073-003PEMETREXED DISODIUMEQ 1GM BASE/VIALPOWDER / INTRAVENOUSAP2022-05-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214073-001PEMETREXED DISODIUMEQ 100MG BASE/VIALPOWDER / INTRAVENOUSAP2022-05-25d06236e962d9…
2024-10-29 15:01 UTC2024-10A214073-002PEMETREXED DISODIUMEQ 500MG BASE/VIALPOWDER / INTRAVENOUSAP2022-05-25d06236e962d9…
2024-10-29 15:01 UTC2024-10A214073-003PEMETREXED DISODIUMEQ 1GM BASE/VIALPOWDER / INTRAVENOUSAP2022-05-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214073-001PEMETREXED DISODIUMEQ 100MG BASE/VIALPOWDER / INTRAVENOUSAP2022-05-2579d66fd596c7…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 96 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09A214073-001AP1c2088c7a36db…
2026-10-15 13:18:302026-09A214073-002AP1c2088c7a36db…
2026-10-15 13:18:302026-09A214073-003AP1c2088c7a36db…
2026-09-14 22:38:342026-08A214073-001AP184e616aacf4f…
2026-09-14 22:38:342026-08A214073-002AP184e616aacf4f…
2026-09-14 22:38:342026-08A214073-003AP184e616aacf4f…
2026-08-18 06:07:402026-07A214073-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A214073-002AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A214073-003AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A214073-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214073-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214073-003AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214073-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214073-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214073-003AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A214073-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214073-002AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214073-003AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214073-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214073-002AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214073-003AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214073-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214073-002AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214073-003AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214073-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214073-002AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214073-003AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214073-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214073-002AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214073-003AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214073-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214073-002AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214073-003AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214073-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214073-002AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214073-003AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214073-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A214073-002AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A214073-003AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214073-001AP179d66fd596c7…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

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

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
pemetrexedPEMETREXED DISODIUMZydus Lifesciences Limited6986de29-b077-48ac-ad2b-0cc478f72d892022-05-26Exact identifier
ndc (package): 70771-1691-1
ndc (package): 70771-1692-1
ndc (package): 70771-1693-1
ndc (product): 70771-1692
ndc (product): 70771-1691
ndc (product): 70771-1693
ndc11 (package): 70771169101
ndc11 (package): 70771169201
ndc11 (package): 70771169301
spl id: fc5f4aa1-92c4-444b-8e64-53708c9a67bc
spl set id: 6986de29-b077-48ac-ad2b-0cc478f72d89

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.