Home NDC 0409-1045-01 PEMETREXED
Product NDC 0409-1045
Requested package NDC 0409-1045-01
11-digit product format 004091045
Labeler code 0409
Product ID 0409-1045_54cf7e63-ef81-4ced-b833-a73ad8980230
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name PEMETREXED
Dosage form INJECTION, SOLUTION, CONCENTRATE
Route INTRAVENOUS
Labeler Hospira, Inc.
Application NDA214218
Marketing category NDA
Marketing start 2022-06-27
Substance PEMETREXED DISODIUM
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 43 .
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 N214218-001 PEMETREXED DISODIUM PEMETREXED DISODIUM EQ 100MG BASE/4ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-06-22 N214218-002 PEMETREXED DISODIUM PEMETREXED DISODIUM EQ 500MG BASE/20ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-06-22 N214218-003 PEMETREXED DISODIUM PEMETREXED DISODIUM EQ 1GM BASE/40ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-06-22
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 2026-09-14 22:38:34 2026-08 N214218-001 PEMETREXED DISODIUM EQ 100MG BASE/4ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-06-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214218-002 PEMETREXED DISODIUM EQ 500MG BASE/20ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-06-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214218-003 PEMETREXED DISODIUM EQ 1GM BASE/40ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-06-22 84e616aacf4f…2026-08-18 06:07:40 2026-07 N214218-001 PEMETREXED DISODIUM EQ 100MG BASE/4ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-06-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214218-002 PEMETREXED DISODIUM EQ 500MG BASE/20ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-06-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214218-003 PEMETREXED DISODIUM EQ 1GM BASE/40ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-06-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N214218-001 PEMETREXED DISODIUM EQ 100MG BASE/4ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-06-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214218-002 PEMETREXED DISODIUM EQ 500MG BASE/20ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-06-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214218-003 PEMETREXED DISODIUM EQ 1GM BASE/40ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-06-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214218-001 PEMETREXED DISODIUM EQ 100MG BASE/4ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-06-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214218-002 PEMETREXED DISODIUM EQ 500MG BASE/20ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-06-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214218-003 PEMETREXED DISODIUM EQ 1GM BASE/40ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-06-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N214218-001 PEMETREXED DISODIUM EQ 100MG BASE/4ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-06-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214218-002 PEMETREXED DISODIUM EQ 500MG BASE/20ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-06-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214218-003 PEMETREXED DISODIUM EQ 1GM BASE/40ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-06-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214218-001 PEMETREXED DISODIUM EQ 100MG BASE/4ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-06-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214218-002 PEMETREXED DISODIUM EQ 500MG BASE/20ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-06-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214218-003 PEMETREXED DISODIUM EQ 1GM BASE/40ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-06-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214218-001 PEMETREXED DISODIUM EQ 100MG BASE/4ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-06-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214218-002 PEMETREXED DISODIUM EQ 500MG BASE/20ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-06-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214218-003 PEMETREXED DISODIUM EQ 1GM BASE/40ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-06-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214218-001 PEMETREXED DISODIUM EQ 100MG BASE/4ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-06-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214218-002 PEMETREXED DISODIUM EQ 500MG BASE/20ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-06-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214218-003 PEMETREXED DISODIUM EQ 1GM BASE/40ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-06-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214218-001 PEMETREXED DISODIUM EQ 100MG BASE/4ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-06-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214218-002 PEMETREXED DISODIUM EQ 500MG BASE/20ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-06-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214218-003 PEMETREXED DISODIUM EQ 1GM BASE/40ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-06-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214218-001 PEMETREXED DISODIUM EQ 100MG BASE/4ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-06-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214218-002 PEMETREXED DISODIUM EQ 500MG BASE/20ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-06-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214218-003 PEMETREXED DISODIUM EQ 1GM BASE/40ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-06-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N214218-001 PEMETREXED DISODIUM EQ 100MG BASE/4ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-06-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N214218-002 PEMETREXED DISODIUM EQ 500MG BASE/20ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-06-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N214218-003 PEMETREXED DISODIUM EQ 1GM BASE/40ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-06-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N214218-001 PEMETREXED DISODIUM EQ 100MG BASE/4ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-06-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N214218-002 PEMETREXED DISODIUM EQ 500MG BASE/20ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-06-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N214218-003 PEMETREXED DISODIUM EQ 1GM BASE/40ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-06-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N214218-001 PEMETREXED DISODIUM EQ 100MG BASE/4ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-06-22 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N214218-002 PEMETREXED DISODIUM EQ 500MG BASE/20ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-06-22 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N214218-003 PEMETREXED DISODIUM EQ 1GM BASE/40ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-06-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N214218-001 PEMETREXED DISODIUM EQ 100MG BASE/4ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-06-22 301d65b070ca…
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 100 mg/4mL
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 0409-1045-01 PEMETREXED 1 in 1 CARTON INJECTION, SOLUTION, CONCENTRATE 1 5 0409-1045-01 PEMETREXED 4 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION, CONCENTRATE 4 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0409-1045 PEMETREXED INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.] 4 Current NDC, Legacy NDC, 2 package rows 20220720_3ae68628-7ab0-4491-b3ae-6a8330b719c8.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 Marketing start Marketing end Sample Exclude flag Status 0409-1045-01 00409104501 1 VIAL, SINGLE-DOSE in 1 CARTON (0409-1045-01) / 4 mL in 1 VIAL, SINGLE-DOSE 2022-06-27 0000-00-00 No No Current