Pemetrexed

Product NDC
63759-3049
11-digit product format
637593049
Labeler code
63759
Product ID
63759-3049_b0e3847a-fdcf-405c-823c-180fa8dad9c2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pemetrexed disodium
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Shilpa Medicare Limited
Application
NDA215179
Marketing category
NDA
Marketing start
2024-01-01
Substance
PEMETREXED DISODIUM HEMIPENTAHYDRATE
Active strength
500 mg/50mL
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 42.

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
N215179-001PEMETREXEDPEMETREXED DISODIUMEQ 100MG/10ML BASE (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2023-05-22
N215179-002PEMETREXEDPEMETREXED DISODIUMEQ 500MG/50ML BASE (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2023-05-22
N215179-003PEMETREXEDPEMETREXED DISODIUMEQ 1GM/100ML BASE (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2023-05-22

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N215179-001111478172035-03-26Drug product2023-06-06
N215179-002111478172035-03-26Drug product2023-06-06
N215179-003111478172035-03-26Drug product2023-06-06

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 2 · 69 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N215179-001PEMETREXEDEQ 100MG/10ML BASE (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2023-05-22caaa826d4ba7…
2026-08-18 06:07:402026-07N215179-002PEMETREXEDEQ 500MG/50ML BASE (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2023-05-22caaa826d4ba7…
2026-08-18 06:07:402026-07N215179-003PEMETREXEDEQ 1GM/100ML BASE (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2023-05-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N215179-001PEMETREXEDEQ 100MG/10ML BASE (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2023-05-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215179-002PEMETREXEDEQ 500MG/50ML BASE (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2023-05-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215179-003PEMETREXEDEQ 1GM/100ML BASE (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2023-05-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N215179-001PEMETREXEDEQ 100MG/10ML BASE (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2023-05-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N215179-002PEMETREXEDEQ 500MG/50ML BASE (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2023-05-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N215179-003PEMETREXEDEQ 1GM/100ML BASE (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2023-05-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08N215179-001PEMETREXEDEQ 100MG/10ML BASE (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2023-05-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08N215179-002PEMETREXEDEQ 500MG/50ML BASE (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2023-05-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08N215179-003PEMETREXEDEQ 1GM/100ML BASE (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2023-05-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N215179-001PEMETREXEDEQ 100MG/10ML BASE (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2023-05-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N215179-002PEMETREXEDEQ 500MG/50ML BASE (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2023-05-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N215179-003PEMETREXEDEQ 1GM/100ML BASE (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2023-05-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N215179-001PEMETREXEDEQ 100MG/10ML BASE (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2023-05-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N215179-002PEMETREXEDEQ 500MG/50ML BASE (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2023-05-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N215179-003PEMETREXEDEQ 1GM/100ML BASE (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2023-05-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N215179-001PEMETREXEDEQ 100MG/10ML BASE (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2023-05-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N215179-002PEMETREXEDEQ 500MG/50ML BASE (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2023-05-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N215179-003PEMETREXEDEQ 1GM/100ML BASE (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2023-05-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N215179-001PEMETREXEDEQ 100MG/10ML BASE (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2023-05-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N215179-002PEMETREXEDEQ 500MG/50ML BASE (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2023-05-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N215179-003PEMETREXEDEQ 1GM/100ML BASE (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2023-05-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N215179-001PEMETREXEDEQ 100MG/10ML BASE (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2023-05-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N215179-002PEMETREXEDEQ 500MG/50ML BASE (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2023-05-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N215179-003PEMETREXEDEQ 1GM/100ML BASE (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2023-05-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N215179-001PEMETREXEDEQ 100MG/10ML BASE (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2023-05-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N215179-002PEMETREXEDEQ 500MG/50ML BASE (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2023-05-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N215179-003PEMETREXEDEQ 1GM/100ML BASE (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2023-05-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N215179-001PEMETREXEDEQ 100MG/10ML BASE (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2023-05-22d06236e962d9…
2024-10-29 15:01 UTC2024-10N215179-002PEMETREXEDEQ 500MG/50ML BASE (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2023-05-22d06236e962d9…
2024-10-29 15:01 UTC2024-10N215179-003PEMETREXEDEQ 1GM/100ML BASE (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2023-05-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N215179-001PEMETREXEDEQ 100MG/10ML BASE (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2023-05-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N215179-002PEMETREXEDEQ 500MG/50ML BASE (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2023-05-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N215179-003PEMETREXEDEQ 1GM/100ML BASE (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2023-05-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N215179-001PEMETREXEDEQ 100MG/10ML BASE (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2023-05-22301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N215179-002PEMETREXEDEQ 500MG/50ML BASE (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2023-05-22301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N215179-003PEMETREXEDEQ 1GM/100ML BASE (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2023-05-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N215179-001PEMETREXEDEQ 100MG/10ML BASE (10MG/ML)SOLUTION / INTRAVENOUSRLD, RS2023-05-221e350fbaab3a…

Observed Orange Book patent history#

Patent history page 1 of 2 · 69 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-18 06:07:402026-07N215179-001111478172035-03-26Drug product2023-06-06caaa826d4ba7…
2026-08-18 06:07:402026-07N215179-002111478172035-03-26Drug product2023-06-06caaa826d4ba7…
2026-08-18 06:07:402026-07N215179-003111478172035-03-26Drug product2023-06-06caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N215179-001111478172035-03-26Drug product2023-06-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215179-002111478172035-03-26Drug product2023-06-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215179-003111478172035-03-26Drug product2023-06-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N215179-001111478172035-03-26Drug product2023-06-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N215179-002111478172035-03-26Drug product2023-06-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N215179-003111478172035-03-26Drug product2023-06-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08N215179-001111478172035-03-26Drug product2023-06-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08N215179-002111478172035-03-26Drug product2023-06-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08N215179-003111478172035-03-26Drug product2023-06-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N215179-001111478172035-03-26Drug product2023-06-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N215179-002111478172035-03-26Drug product2023-06-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N215179-003111478172035-03-26Drug product2023-06-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N215179-001111478172035-03-26Drug product2023-06-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N215179-002111478172035-03-26Drug product2023-06-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N215179-003111478172035-03-26Drug product2023-06-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N215179-001111478172035-03-26Drug product2023-06-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N215179-002111478172035-03-26Drug product2023-06-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N215179-003111478172035-03-26Drug product2023-06-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N215179-001111478172035-03-26Drug product2023-06-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N215179-002111478172035-03-26Drug product2023-06-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N215179-003111478172035-03-26Drug product2023-06-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N215179-001111478172035-03-26Drug product2023-06-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N215179-002111478172035-03-26Drug product2023-06-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N215179-003111478172035-03-26Drug product2023-06-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N215179-001111478172035-03-26Drug product2023-06-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N215179-002111478172035-03-26Drug product2023-06-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N215179-003111478172035-03-26Drug product2023-06-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N215179-001111478172035-03-26Drug product2023-06-06d06236e962d9…
2024-10-29 15:01 UTC2024-10N215179-002111478172035-03-26Drug product2023-06-06d06236e962d9…
2024-10-29 15:01 UTC2024-10N215179-003111478172035-03-26Drug product2023-06-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N215179-001111478172035-03-26Drug product2023-06-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N215179-002111478172035-03-26Drug product2023-06-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N215179-003111478172035-03-26Drug product2023-06-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N215179-001111478172035-03-26Drug product2023-06-06301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N215179-002111478172035-03-26Drug product2023-06-06301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N215179-003111478172035-03-26Drug product2023-06-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N215179-001111478172035-03-26Drug product2023-06-061e350fbaab3a…

Additional Listing Data#

Finished product
Yes
Brand name base
Pemetrexed
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PEMETREXED DISODIUM HEMIPENTAHYDRATE500 mg/50mL

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 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2637958Internal RxNorm lookup
2637966Internal RxNorm lookup
2637968Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
fe432994-e61b-4a87-8c98-cc20b847d0feAvailable 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
2e254488-9fcb-41b3-a7c3-e2c9a3941b29Product name120200603
b4ff0805-126a-406d-9cae-fc34fd8e8889Product name120190711

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63759-3049-1Pemetrexed1 in 1 CARTONINJECTION18
63759-3049-1Pemetrexed50 mL in 1 VIALINJECTION508

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63759-3049PEMETREXED (PEMETREXED DISODIUM) INJECTION [SHILPA MEDICARE LIMITED]8Current NDC, 2 package rows20241205_fe432994-e61b-4a87-8c98-cc20b847d0fe.zip

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PEMRYDI RTUPEMETREXED DISODIUMAmneal Pharmaceuticals LLC0f006b06-ab85-423d-ba0c-dfc3fc25844e2025-07-08Warnings, Adverse reactionsExact identifier
application applno (NDA): 215179
application number: NDA215179
PemetrexedPEMETREXED DISODIUMShilpa Medicare Limitedfe432994-e61b-4a87-8c98-cc20b847d0fe2024-11-28Warnings, Adverse reactionsExact identifier
application applno (NDA): 215179
application number: NDA215179
ndc (product): 63759-3049

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2637958PEMEtrexed 100 MG in 10 ML InjectionPSNfe432994-e61b-4a87-8c98-cc20b847d0fe8
2637966PEMEtrexed 1000 MG in 100 ML InjectionPSNfe432994-e61b-4a87-8c98-cc20b847d0fe8
2637968PEMEtrexed 500 MG in 50 ML InjectionPSNfe432994-e61b-4a87-8c98-cc20b847d0fe8
263795810 ML pemetrexed 10 MG/ML InjectionSCDfe432994-e61b-4a87-8c98-cc20b847d0fe8
2637966100 ML pemetrexed 10 MG/ML InjectionSCDfe432994-e61b-4a87-8c98-cc20b847d0fe8
263796850 ML pemetrexed 10 MG/ML InjectionSCDfe432994-e61b-4a87-8c98-cc20b847d0fe8
2637958pemetrexed (as disodium hemipentahydrate) 10 MG/ML per 10 ML InjectionSYfe432994-e61b-4a87-8c98-cc20b847d0fe8
2637966pemetrexed (as disodium hemipentahydrate) 10 MG/ML per 100 ML InjectionSYfe432994-e61b-4a87-8c98-cc20b847d0fe8
2637968pemetrexed (as disodium hemipentahydrate) 10 MG/ML per 50 ML InjectionSYfe432994-e61b-4a87-8c98-cc20b847d0fe8
2637958pemetrexed (as disodium hemipentahydrate) 100 MG per 10 ML InjectionSYfe432994-e61b-4a87-8c98-cc20b847d0fe8
2637966pemetrexed (as disodium hemipentahydrate) 1000 MG per 100 ML InjectionSYfe432994-e61b-4a87-8c98-cc20b847d0fe8
2637968pemetrexed (as disodium hemipentahydrate) 500 MG per 50 ML InjectionSYfe432994-e61b-4a87-8c98-cc20b847d0fe8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
63759-3049-1637593049011 VIAL in 1 CARTON (63759-3049-1) / 50 mL in 1 VIAL1 vial2024-01-01NoNoCurrent