Home NDC 72338-100 Pemetrexed
Product NDC 72338-100
11-digit product format 723380100
Labeler code 72338
Product ID 72338-100_d0687ba7-a598-4409-8459-0204bcb6d9f3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Pemetrexed disodium
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Waverley Pharma Inc
Application ANDA211899
Marketing category ANDA
Marketing start 2018-06-04
Substance PEMETREXED DISODIUM HEPTAHYDRATE
Active strength 100 mg/4mL
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A211899-001 PEMETREXED DISODIUM PEMETREXED DISODIUM EQ 100MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 A211899-002 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 · 60 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 A211899-001 PEMETREXED DISODIUM EQ 100MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211899-002 PEMETREXED DISODIUM EQ 500MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A211899-001 PEMETREXED DISODIUM EQ 100MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211899-002 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 A211899-001 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 A211899-002 PEMETREXED DISODIUM EQ 500MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211899-001 PEMETREXED DISODIUM EQ 100MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211899-002 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 A211899-001 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 A211899-002 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 A211899-001 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 A211899-002 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 A211899-001 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 A211899-002 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 A211899-001 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 A211899-002 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 A211899-001 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 A211899-002 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 A211899-001 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 A211899-002 PEMETREXED DISODIUM EQ 500MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211899-001 PEMETREXED DISODIUM EQ 100MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A211899-002 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 A211899-001 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 A211899-002 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 A211899-001 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 A211899-002 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 A211899-001 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 A211899-002 PEMETREXED DISODIUM EQ 500MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211899-001 PEMETREXED DISODIUM EQ 100MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A211899-002 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 A211899-001 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 A211899-002 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 A211899-001 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 A211899-002 PEMETREXED DISODIUM EQ 500MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A211899-001 PEMETREXED DISODIUM EQ 100MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A211899-002 PEMETREXED DISODIUM EQ 500MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A211899-001 PEMETREXED DISODIUM EQ 100MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A211899-002 PEMETREXED DISODIUM EQ 500MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A211899-001 PEMETREXED DISODIUM EQ 100MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A211899-002 PEMETREXED DISODIUM EQ 500MG BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 a72a2bbeb626…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 60 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/4mL
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 · 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 72338-100-01 Pemetrexed 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 4 72338-100-01 Pemetrexed 4 mL in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 4 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72338-100 PEMETREXED (PEMETREXED DISODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [WAVERLEY PHARMA INC] 4 Current NDC, Legacy NDC, 2 package rows 20240111_95633c32-89a8-4275-94e7-939c9f2e6135.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 Marketing end Sample Exclude flag Status 72338-100-01 72338010001 1 VIAL in 1 CARTON (72338-100-01) / 4 mL in 1 VIAL 1 vial 2018-06-04 0000-00-00 No No Current