Home NDC 71288-145 Pemetrexed
Product NDC 71288-145
11-digit product format 712880145
Labeler code 71288
Product ID 71288-145_b369ac27-0118-4e53-be05-c9ba2dbf6875
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Pemetrexed disodium
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Meitheal Pharmaceuticals Inc.
Application ANDA215479
Marketing category ANDA
Marketing start 2022-12-13
Substance PEMETREXED DISODIUM HEPTAHYDRATE
Active strength 100 mg/4.2mL
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 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A215479-001 PEMETREXED DISODIUM PEMETREXED DISODIUM EQ 100MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-12-13 A215479-002 PEMETREXED DISODIUM PEMETREXED DISODIUM EQ 500MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-12-13 A215479-003 PEMETREXED DISODIUM PEMETREXED DISODIUM EQ 750MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-12-13 A215479-004 PEMETREXED DISODIUM PEMETREXED DISODIUM EQ 1GM BASE/VIAL POWDER / INTRAVENOUS AP 2022-12-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A215479-001 PEMETREXED DISODIUM EQ 100MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-12-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A215479-002 PEMETREXED DISODIUM EQ 500MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-12-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A215479-003 PEMETREXED DISODIUM EQ 750MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-12-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A215479-004 PEMETREXED DISODIUM EQ 1GM BASE/VIAL POWDER / INTRAVENOUS AP 2022-12-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215479-001 PEMETREXED DISODIUM EQ 100MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-12-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215479-002 PEMETREXED DISODIUM EQ 500MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-12-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215479-003 PEMETREXED DISODIUM EQ 750MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-12-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215479-004 PEMETREXED DISODIUM EQ 1GM BASE/VIAL POWDER / INTRAVENOUS AP 2022-12-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215479-001 PEMETREXED DISODIUM EQ 100MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-12-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A215479-002 PEMETREXED DISODIUM EQ 500MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-12-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A215479-003 PEMETREXED DISODIUM EQ 750MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-12-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A215479-004 PEMETREXED DISODIUM EQ 1GM BASE/VIAL POWDER / INTRAVENOUS AP 2022-12-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215479-001 PEMETREXED DISODIUM EQ 100MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-12-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215479-002 PEMETREXED DISODIUM EQ 500MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-12-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215479-003 PEMETREXED DISODIUM EQ 750MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-12-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215479-004 PEMETREXED DISODIUM EQ 1GM BASE/VIAL POWDER / INTRAVENOUS AP 2022-12-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215479-001 PEMETREXED DISODIUM EQ 100MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-12-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215479-002 PEMETREXED DISODIUM EQ 500MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-12-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215479-003 PEMETREXED DISODIUM EQ 750MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-12-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215479-004 PEMETREXED DISODIUM EQ 1GM BASE/VIAL POWDER / INTRAVENOUS AP 2022-12-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215479-001 PEMETREXED DISODIUM EQ 100MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-12-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215479-002 PEMETREXED DISODIUM EQ 500MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-12-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215479-003 PEMETREXED DISODIUM EQ 750MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-12-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215479-004 PEMETREXED DISODIUM EQ 1GM BASE/VIAL POWDER / INTRAVENOUS AP 2022-12-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215479-001 PEMETREXED DISODIUM EQ 100MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-12-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215479-002 PEMETREXED DISODIUM EQ 500MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-12-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215479-003 PEMETREXED DISODIUM EQ 750MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-12-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215479-004 PEMETREXED DISODIUM EQ 1GM BASE/VIAL POWDER / INTRAVENOUS AP 2022-12-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215479-001 PEMETREXED DISODIUM EQ 100MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-12-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215479-002 PEMETREXED DISODIUM EQ 500MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-12-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215479-003 PEMETREXED DISODIUM EQ 750MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-12-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215479-004 PEMETREXED DISODIUM EQ 1GM BASE/VIAL POWDER / INTRAVENOUS AP 2022-12-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215479-001 PEMETREXED DISODIUM EQ 100MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-12-13 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215479-002 PEMETREXED DISODIUM EQ 500MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-12-13 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215479-003 PEMETREXED DISODIUM EQ 750MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-12-13 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215479-004 PEMETREXED DISODIUM EQ 1GM BASE/VIAL POWDER / INTRAVENOUS AP 2022-12-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215479-001 PEMETREXED DISODIUM EQ 100MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-12-13 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A215479-002 PEMETREXED DISODIUM EQ 500MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-12-13 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A215479-003 PEMETREXED DISODIUM EQ 750MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-12-13 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A215479-004 PEMETREXED DISODIUM EQ 1GM BASE/VIAL POWDER / INTRAVENOUS AP 2022-12-13 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 96 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Pemetrexed
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PEMETREXED DISODIUM HEPTAHYDRATE 100 mg/4.2mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9T47E4OM16 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1728072 Internal RxNorm lookup 1728077 Internal RxNorm lookup 2601728 Internal RxNorm lookup 2602136 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 71288-145-10 Pemetrexed 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 4 71288-145-10 Pemetrexed 4.2 mL in 1 VIAL, SINGLE-DOSE INJECTION, POWDER, LYOPHILIZED, 4.2 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71288-145 PEMETREXED (PEMETREXED DISODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MEITHEAL PHARMACEUTICALS INC.] 4 Current NDC, Legacy NDC, 2 package rows 20221223_b185f459-5489-4e18-8521-1686b5d16f67.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 Marketing start Marketing end Sample Exclude flag Status 71288-145-10 71288014510 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-145-10) / 4.2 mL in 1 VIAL, SINGLE-DOSE 2022-12-13 0000-00-00 No No Current