Home NDC 0781-3520 Pemetrexed
Product NDC 0781-3520
11-digit product format 007813520
Labeler code 0781
Product ID 0781-3520_764ab64b-c642-4314-83a9-efee79fe83a3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Pemetrexed disodium
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Sandoz Inc.
Application NDA214657
Marketing category NDA
Marketing start 2022-06-08
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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N214657-001 PEMETREXED DISODIUM PEMETREXED DISODIUM EQ 100MG BASE/4ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-05-26 N214657-002 PEMETREXED DISODIUM PEMETREXED DISODIUM EQ 500MG BASE/20ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-05-26 N214657-003 PEMETREXED DISODIUM PEMETREXED DISODIUM EQ 1GM BASE/40ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-05-26
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 · 90 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 2026-08-18 06:07:40 2026-07 N214657-001 PEMETREXED DISODIUM EQ 100MG BASE/4ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-05-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214657-002 PEMETREXED DISODIUM EQ 500MG BASE/20ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-05-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214657-003 PEMETREXED DISODIUM EQ 1GM BASE/40ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-05-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N214657-001 PEMETREXED DISODIUM EQ 100MG BASE/4ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-05-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214657-002 PEMETREXED DISODIUM EQ 500MG BASE/20ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-05-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214657-003 PEMETREXED DISODIUM EQ 1GM BASE/40ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-05-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214657-001 PEMETREXED DISODIUM EQ 100MG BASE/4ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-05-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214657-002 PEMETREXED DISODIUM EQ 500MG BASE/20ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-05-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214657-003 PEMETREXED DISODIUM EQ 1GM BASE/40ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-05-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N214657-001 PEMETREXED DISODIUM EQ 100MG BASE/4ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-05-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214657-002 PEMETREXED DISODIUM EQ 500MG BASE/20ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-05-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214657-003 PEMETREXED DISODIUM EQ 1GM BASE/40ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-05-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214657-001 PEMETREXED DISODIUM EQ 100MG BASE/4ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-05-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214657-002 PEMETREXED DISODIUM EQ 500MG BASE/20ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-05-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214657-003 PEMETREXED DISODIUM EQ 1GM BASE/40ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-05-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214657-001 PEMETREXED DISODIUM EQ 100MG BASE/4ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-05-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214657-002 PEMETREXED DISODIUM EQ 500MG BASE/20ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-05-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214657-003 PEMETREXED DISODIUM EQ 1GM BASE/40ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-05-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214657-001 PEMETREXED DISODIUM EQ 100MG BASE/4ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-05-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214657-002 PEMETREXED DISODIUM EQ 500MG BASE/20ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-05-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214657-003 PEMETREXED DISODIUM EQ 1GM BASE/40ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-05-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214657-001 PEMETREXED DISODIUM EQ 100MG BASE/4ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-05-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214657-002 PEMETREXED DISODIUM EQ 500MG BASE/20ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-05-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214657-003 PEMETREXED DISODIUM EQ 1GM BASE/40ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-05-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214657-001 PEMETREXED DISODIUM EQ 100MG BASE/4ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-05-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214657-002 PEMETREXED DISODIUM EQ 500MG BASE/20ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-05-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214657-003 PEMETREXED DISODIUM EQ 1GM BASE/40ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-05-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N214657-001 PEMETREXED DISODIUM EQ 100MG BASE/4ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-05-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N214657-002 PEMETREXED DISODIUM EQ 500MG BASE/20ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-05-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N214657-003 PEMETREXED DISODIUM EQ 1GM BASE/40ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-05-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N214657-001 PEMETREXED DISODIUM EQ 100MG BASE/4ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-05-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N214657-002 PEMETREXED DISODIUM EQ 500MG BASE/20ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-05-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N214657-003 PEMETREXED DISODIUM EQ 1GM BASE/40ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-05-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N214657-001 PEMETREXED DISODIUM EQ 100MG BASE/4ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-05-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N214657-002 PEMETREXED DISODIUM EQ 500MG BASE/20ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-05-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N214657-003 PEMETREXED DISODIUM EQ 1GM BASE/40ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-05-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N214657-001 PEMETREXED DISODIUM EQ 100MG BASE/4ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-05-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N214657-002 PEMETREXED DISODIUM EQ 500MG BASE/20ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-05-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N214657-003 PEMETREXED DISODIUM EQ 1GM BASE/40ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-05-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N214657-001 PEMETREXED DISODIUM EQ 100MG BASE/4ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-05-26 1e350fbaab3a…
Additional Listing Data#
Finished product Yes
Brand name base Pemetrexed
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PEMETREXED DISODIUM 1000 mg/40mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2PKU919BA9 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2602363 Internal RxNorm lookup 2602365 Internal RxNorm lookup 2602366 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 0781-3520-91 Pemetrexed 1 in 1 CARTON INJECTION, SOLUTION 1 6 0781-3520-91 Pemetrexed 40 mL in 1 VIAL INJECTION, SOLUTION 40 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0781-3520 PEMETREXED (PEMETREXED DISODIUM) INJECTION, SOLUTION [SANDOZ INC.] 5 Current NDC, Legacy NDC, 2 package rows 20240925_7ac04ab7-7f8c-46ce-ab56-a7a08cd02ab3.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 0781-3520-91 00781352091 1 in 1 CARTON Historical