Home NDC 43547-632 Pemetrexed
Product NDC 43547-632
11-digit product format 435470632
Labeler code 43547
Product ID 43547-632_b2088b2f-1c23-4bbf-91b3-1fc879180b8f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Pemetrexed
Dosage form INJECTION, POWDER, FOR SOLUTION
Route INTRAVENOUS
Labeler Solco Healthcare US, LLC
Application ANDA216582
Marketing category ANDA
Marketing start 2024-07-01
Substance PEMETREXED DISODIUM HEMIPENTAHYDRATE
Active strength 100 mg/1
Pharmacologic classes Folate Analog Metabolic Inhibitor [EPC], Folic Acid Metabolism Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A216582-001 PEMETREXED DISODIUM PEMETREXED DISODIUM EQ 100MG BASE/VIAL POWDER / INTRAVENOUS AP 2023-12-11
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A216582-001 AP
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.
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 A216582-001 PEMETREXED DISODIUM EQ 100MG BASE/VIAL POWDER / INTRAVENOUS AP 2023-12-11 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216582-001 PEMETREXED DISODIUM EQ 100MG BASE/VIAL POWDER / INTRAVENOUS AP 2023-12-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216582-001 PEMETREXED DISODIUM EQ 100MG BASE/VIAL POWDER / INTRAVENOUS AP 2023-12-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216582-001 PEMETREXED DISODIUM EQ 100MG BASE/VIAL POWDER / INTRAVENOUS AP 2023-12-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216582-001 PEMETREXED DISODIUM EQ 100MG BASE/VIAL POWDER / INTRAVENOUS AP 2023-12-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216582-001 PEMETREXED DISODIUM EQ 100MG BASE/VIAL POWDER / INTRAVENOUS AP 2023-12-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216582-001 PEMETREXED DISODIUM EQ 100MG BASE/VIAL POWDER / INTRAVENOUS AP 2023-12-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216582-001 PEMETREXED DISODIUM EQ 100MG BASE/VIAL POWDER / INTRAVENOUS AP 2023-12-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216582-001 PEMETREXED DISODIUM EQ 100MG BASE/VIAL POWDER / INTRAVENOUS AP 2023-12-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216582-001 PEMETREXED DISODIUM EQ 100MG BASE/VIAL POWDER / INTRAVENOUS AP 2023-12-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216582-001 PEMETREXED DISODIUM EQ 100MG BASE/VIAL POWDER / INTRAVENOUS AP 2023-12-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216582-001 PEMETREXED DISODIUM EQ 100MG BASE/VIAL POWDER / INTRAVENOUS AP 2023-12-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216582-001 PEMETREXED DISODIUM EQ 100MG BASE/VIAL POWDER / INTRAVENOUS AP 2023-12-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216582-001 PEMETREXED DISODIUM EQ 100MG BASE/VIAL POWDER / INTRAVENOUS AP 2023-12-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A216582-001 PEMETREXED DISODIUM EQ 100MG BASE/VIAL POWDER / INTRAVENOUS AP 2023-12-11 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216582-001 PEMETREXED DISODIUM EQ 100MG BASE/VIAL POWDER / INTRAVENOUS AP 2023-12-11 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A216582-001 PEMETREXED DISODIUM EQ 100MG BASE/VIAL POWDER / INTRAVENOUS AP 2023-12-11 1c564ffb4f44…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216582-001 PEMETREXED DISODIUM EQ 100MG BASE/VIAL POWDER / INTRAVENOUS AP 2023-12-11 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Pemetrexed
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PEMETREXED DISODIUM HEMIPENTAHYDRATE 100 mg/1
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 43547-632-01 Pemetrexed 100 in 1 VIAL INJECTION, POWDER, FOR SOLUTION 100 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43547-632 PEMETREXED INJECTION, POWDER, FOR SOLUTION [SOLCO HEALTHCARE US, LLC] 1 Current NDC, 1 package rows 20240802_bd0ada98-3237-4465-8ba2-3a12c33116fb.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 Sample Exclude flag Status 43547-632-01 43547063201 100 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (43547-632-01) 2024-07-01 No No Current