Home NDC 63759-3050 Pemetrexed
Product NDC 63759-3050
11-digit product format 637593050
Labeler code 63759
Product ID 63759-3050_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 1000 mg/100mL
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 43 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N215179-001 PEMETREXED PEMETREXED DISODIUM EQ 100MG/10ML BASE (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-05-22 N215179-002 PEMETREXED PEMETREXED DISODIUM EQ 500MG/50ML BASE (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-05-22 N215179-003 PEMETREXED PEMETREXED DISODIUM EQ 1GM/100ML BASE (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-05-22
Orange Book patents# Current patent rows page 1 of 1 · 3 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N215179-001 11147817 2035-03-26 Drug product 2023-06-06 N215179-002 11147817 2035-03-26 Drug product 2023-06-06 N215179-003 11147817 2035-03-26 Drug product 2023-06-06
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 · 72 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 N215179-001 PEMETREXED EQ 100MG/10ML BASE (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-05-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215179-002 PEMETREXED EQ 500MG/50ML BASE (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-05-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215179-003 PEMETREXED EQ 1GM/100ML BASE (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-05-22 84e616aacf4f…2026-08-18 06:07:40 2026-07 N215179-001 PEMETREXED EQ 100MG/10ML BASE (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-05-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215179-002 PEMETREXED EQ 500MG/50ML BASE (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-05-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215179-003 PEMETREXED EQ 1GM/100ML BASE (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-05-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N215179-001 PEMETREXED EQ 100MG/10ML BASE (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-05-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215179-002 PEMETREXED EQ 500MG/50ML BASE (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-05-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215179-003 PEMETREXED EQ 1GM/100ML BASE (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-05-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215179-001 PEMETREXED EQ 100MG/10ML BASE (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-05-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215179-002 PEMETREXED EQ 500MG/50ML BASE (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-05-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215179-003 PEMETREXED EQ 1GM/100ML BASE (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-05-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N215179-001 PEMETREXED EQ 100MG/10ML BASE (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-05-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215179-002 PEMETREXED EQ 500MG/50ML BASE (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-05-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215179-003 PEMETREXED EQ 1GM/100ML BASE (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-05-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215179-001 PEMETREXED EQ 100MG/10ML BASE (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-05-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215179-002 PEMETREXED EQ 500MG/50ML BASE (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-05-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215179-003 PEMETREXED EQ 1GM/100ML BASE (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-05-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215179-001 PEMETREXED EQ 100MG/10ML BASE (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-05-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215179-002 PEMETREXED EQ 500MG/50ML BASE (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-05-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215179-003 PEMETREXED EQ 1GM/100ML BASE (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-05-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215179-001 PEMETREXED EQ 100MG/10ML BASE (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-05-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215179-002 PEMETREXED EQ 500MG/50ML BASE (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-05-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215179-003 PEMETREXED EQ 1GM/100ML BASE (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-05-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215179-001 PEMETREXED EQ 100MG/10ML BASE (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-05-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215179-002 PEMETREXED EQ 500MG/50ML BASE (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-05-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215179-003 PEMETREXED EQ 1GM/100ML BASE (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-05-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215179-001 PEMETREXED EQ 100MG/10ML BASE (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-05-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215179-002 PEMETREXED EQ 500MG/50ML BASE (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-05-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215179-003 PEMETREXED EQ 1GM/100ML BASE (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-05-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N215179-001 PEMETREXED EQ 100MG/10ML BASE (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-05-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N215179-002 PEMETREXED EQ 500MG/50ML BASE (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-05-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N215179-003 PEMETREXED EQ 1GM/100ML BASE (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-05-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N215179-001 PEMETREXED EQ 100MG/10ML BASE (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-05-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N215179-002 PEMETREXED EQ 500MG/50ML BASE (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-05-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N215179-003 PEMETREXED EQ 1GM/100ML BASE (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-05-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N215179-001 PEMETREXED EQ 100MG/10ML BASE (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-05-22 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N215179-002 PEMETREXED EQ 500MG/50ML BASE (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-05-22 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N215179-003 PEMETREXED EQ 1GM/100ML BASE (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-05-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N215179-001 PEMETREXED EQ 100MG/10ML BASE (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-05-22 301d65b070ca…
Observed Orange Book patent history# Patent history page 1 of 2 · 72 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N215179-001 11147817 2035-03-26 Drug product 2023-06-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215179-002 11147817 2035-03-26 Drug product 2023-06-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215179-003 11147817 2035-03-26 Drug product 2023-06-06 84e616aacf4f…2026-08-18 06:07:40 2026-07 N215179-001 11147817 2035-03-26 Drug product 2023-06-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215179-002 11147817 2035-03-26 Drug product 2023-06-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215179-003 11147817 2035-03-26 Drug product 2023-06-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N215179-001 11147817 2035-03-26 Drug product 2023-06-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215179-002 11147817 2035-03-26 Drug product 2023-06-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215179-003 11147817 2035-03-26 Drug product 2023-06-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215179-001 11147817 2035-03-26 Drug product 2023-06-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215179-002 11147817 2035-03-26 Drug product 2023-06-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215179-003 11147817 2035-03-26 Drug product 2023-06-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N215179-001 11147817 2035-03-26 Drug product 2023-06-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215179-002 11147817 2035-03-26 Drug product 2023-06-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215179-003 11147817 2035-03-26 Drug product 2023-06-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215179-001 11147817 2035-03-26 Drug product 2023-06-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215179-002 11147817 2035-03-26 Drug product 2023-06-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215179-003 11147817 2035-03-26 Drug product 2023-06-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215179-001 11147817 2035-03-26 Drug product 2023-06-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215179-002 11147817 2035-03-26 Drug product 2023-06-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215179-003 11147817 2035-03-26 Drug product 2023-06-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215179-001 11147817 2035-03-26 Drug product 2023-06-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215179-002 11147817 2035-03-26 Drug product 2023-06-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215179-003 11147817 2035-03-26 Drug product 2023-06-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215179-001 11147817 2035-03-26 Drug product 2023-06-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215179-002 11147817 2035-03-26 Drug product 2023-06-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215179-003 11147817 2035-03-26 Drug product 2023-06-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215179-001 11147817 2035-03-26 Drug product 2023-06-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215179-002 11147817 2035-03-26 Drug product 2023-06-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215179-003 11147817 2035-03-26 Drug product 2023-06-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N215179-001 11147817 2035-03-26 Drug product 2023-06-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N215179-002 11147817 2035-03-26 Drug product 2023-06-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N215179-003 11147817 2035-03-26 Drug product 2023-06-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N215179-001 11147817 2035-03-26 Drug product 2023-06-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N215179-002 11147817 2035-03-26 Drug product 2023-06-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N215179-003 11147817 2035-03-26 Drug product 2023-06-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N215179-001 11147817 2035-03-26 Drug product 2023-06-06 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N215179-002 11147817 2035-03-26 Drug product 2023-06-06 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N215179-003 11147817 2035-03-26 Drug product 2023-06-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N215179-001 11147817 2035-03-26 Drug product 2023-06-06 301d65b070ca…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Pemetrexed
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PEMETREXED DISODIUM HEMIPENTAHYDRATE 1000 mg/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination F4GSH45R4C Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2637958 Internal RxNorm lookup 2637966 Internal RxNorm lookup 2637968 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63759-3050-1 Pemetrexed 100 mL in 1 VIAL INJECTION 100 8 63759-3050-1 Pemetrexed 1 in 1 CARTON INJECTION 1 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63759-3050 PEMETREXED (PEMETREXED DISODIUM) INJECTION [SHILPA MEDICARE LIMITED] 8 Current NDC, 2 package rows 20241205_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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 63759-3050-1 63759305001 1 VIAL in 1 CARTON (63759-3050-1) / 100 mL in 1 VIAL 1 vial 2024-01-01 No No Current