Home NDC 71288-166 Pemetrexed
Product NDC 71288-166
11-digit product format 712880166
Labeler code 71288
Product ID 71288-166_235ded9d-0115-4335-b7fb-e0d4fa85b6f6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Pemetrexed disodium
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Meitheal Pharmaceuticals Inc.
Application ANDA208696
Marketing category ANDA
Marketing start 2022-05-25
Substance PEMETREXED DISODIUM HEMIPENTAHYDRATE
Active strength 100 mg/10mL
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A208696-001 PEMETREXED DISODIUM PEMETREXED DISODIUM EQ 100MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 A208696-002 PEMETREXED DISODIUM PEMETREXED DISODIUM EQ 500MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 2 · 62 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 A208696-001 PEMETREXED DISODIUM EQ 100MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 A208696-002 PEMETREXED DISODIUM EQ 500MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 84e616aacf4f…2026-08-18 06:07:40 2026-07 A208696-001 PEMETREXED DISODIUM EQ 100MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208696-002 PEMETREXED DISODIUM EQ 500MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A208696-001 PEMETREXED DISODIUM EQ 100MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208696-002 PEMETREXED DISODIUM EQ 500MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208696-001 PEMETREXED DISODIUM EQ 100MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208696-002 PEMETREXED DISODIUM EQ 500MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208696-001 PEMETREXED DISODIUM EQ 100MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208696-002 PEMETREXED DISODIUM EQ 500MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208696-001 PEMETREXED DISODIUM EQ 100MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208696-002 PEMETREXED DISODIUM EQ 500MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208696-001 PEMETREXED DISODIUM EQ 100MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208696-002 PEMETREXED DISODIUM EQ 500MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208696-001 PEMETREXED DISODIUM EQ 100MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208696-002 PEMETREXED DISODIUM EQ 500MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208696-001 PEMETREXED DISODIUM EQ 100MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208696-002 PEMETREXED DISODIUM EQ 500MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208696-001 PEMETREXED DISODIUM EQ 100MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208696-002 PEMETREXED DISODIUM EQ 500MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208696-001 PEMETREXED DISODIUM EQ 100MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208696-002 PEMETREXED DISODIUM EQ 500MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208696-001 PEMETREXED DISODIUM EQ 100MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A208696-002 PEMETREXED DISODIUM EQ 500MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208696-001 PEMETREXED DISODIUM EQ 100MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208696-002 PEMETREXED DISODIUM EQ 500MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208696-001 PEMETREXED DISODIUM EQ 100MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208696-002 PEMETREXED DISODIUM EQ 500MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208696-001 PEMETREXED DISODIUM EQ 100MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208696-002 PEMETREXED DISODIUM EQ 500MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A208696-001 PEMETREXED DISODIUM EQ 100MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A208696-002 PEMETREXED DISODIUM EQ 500MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208696-001 PEMETREXED DISODIUM EQ 100MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208696-002 PEMETREXED DISODIUM EQ 500MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 5c6f7cd8ea54…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A208696-001 PEMETREXED DISODIUM EQ 100MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A208696-002 PEMETREXED DISODIUM EQ 500MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A208696-001 PEMETREXED DISODIUM EQ 100MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A208696-002 PEMETREXED DISODIUM EQ 500MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A208696-001 PEMETREXED DISODIUM EQ 100MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A208696-002 PEMETREXED DISODIUM EQ 500MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 ea1830bbd6c7…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 62 observed states.
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 100 mg/10mL
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1728072 Internal RxNorm lookup 1728077 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 71288-166-10 Pemetrexed 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 4 71288-166-10 Pemetrexed 10 mL in 1 VIAL, SINGLE-DOSE INJECTION, POWDER, LYOPHILIZED, 10 4 71288-166-91 Pemetrexed 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 4 71288-166-91 Pemetrexed 10 mL in 1 VIAL, SINGLE-DOSE INJECTION, POWDER, LYOPHILIZED, 10 4 71288-166-92 Pemetrexed 10 mL in 1 VIAL, SINGLE-DOSE INJECTION, POWDER, LYOPHILIZED, 10 3 71288-166-92 Pemetrexed 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71288-166 PEMETREXED (PEMETREXED DISODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MEITHEAL PHARMACEUTICALS INC.] 4 Current NDC, Legacy NDC, 2 package rows 20240423_1ceacc3e-f555-489b-8b16-2baa58b2f5a5.zip 71288-166 PEMETREXED (PEMETREXED DISODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MEITHEAL PHARMACEUTICALS INC.] 3 Current NDC, Legacy NDC, 2 package rows 20240423_5fb3a2d5-b9ec-4044-abb9-3e0d848a448e.zip 71288-166 PEMETREXED (PEMETREXED DISODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MEITHEAL PHARMACEUTICALS INC.] 3 Current NDC, Legacy NDC, 2 package rows 20240423_e0d000a3-b9d2-4fa9-9591-f7acb077481d.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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 71288-166-10 71288016610 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-166-10) / 10 mL in 1 VIAL, SINGLE-DOSE 2022-05-25 0000-00-00 No No Current 71288-166-91 71288016691 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-166-91) / 10 mL in 1 VIAL, SINGLE-DOSE 2022-05-25 0000-00-00 No No Current 71288-166-92 71288016692 10 mL in 1 VIAL, SINGLE-DOSE 10 ml Historical