Home NDC 16729-522 Pemetrexed
Product NDC 16729-522
11-digit product format 167290522
Labeler code 16729
Product ID 16729-522_e85650c8-383d-add2-e053-2a95a90a1f71
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Pemetrexed disodium
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Accord Healthcare Inc.
Application NDA214408
Marketing category NDA
Marketing start 2022-09-08
Marketing end 0000-00-00
Substance PEMETREXED DISODIUM HEMIPENTAHYDRATE
Active strength 25 mg/mL
Pharmacologic classes Folate Analog Metabolic Inhibitor [EPC], Folic Acid Metabolism Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 30 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 N214408-001 PEMETREXED DISODIUM PEMETREXED DISODIUM EQ 100MG BASE/4ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD 2022-07-19 N214408-002 PEMETREXED DISODIUM PEMETREXED DISODIUM EQ 500MG BASE/20ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD 2022-07-19 N214408-003 PEMETREXED DISODIUM PEMETREXED DISODIUM EQ 850MG BASE/34ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD 2022-07-19 N214408-004 PEMETREXED DISODIUM PEMETREXED DISODIUM EQ 1GM BASE/40ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD 2022-07-19
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 · 116 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 N214408-001 PEMETREXED DISODIUM EQ 100MG BASE/4ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD 2022-07-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214408-002 PEMETREXED DISODIUM EQ 500MG BASE/20ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD 2022-07-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214408-003 PEMETREXED DISODIUM EQ 850MG BASE/34ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD 2022-07-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214408-004 PEMETREXED DISODIUM EQ 1GM BASE/40ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD 2022-07-19 84e616aacf4f…2026-08-18 06:07:40 2026-07 N214408-001 PEMETREXED DISODIUM EQ 100MG BASE/4ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD 2022-07-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214408-002 PEMETREXED DISODIUM EQ 500MG BASE/20ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD 2022-07-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214408-003 PEMETREXED DISODIUM EQ 850MG BASE/34ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD 2022-07-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214408-004 PEMETREXED DISODIUM EQ 1GM BASE/40ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD 2022-07-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N214408-001 PEMETREXED DISODIUM EQ 100MG BASE/4ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD 2022-07-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214408-002 PEMETREXED DISODIUM EQ 500MG BASE/20ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD 2022-07-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214408-003 PEMETREXED DISODIUM EQ 850MG BASE/34ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD 2022-07-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214408-004 PEMETREXED DISODIUM EQ 1GM BASE/40ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD 2022-07-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214408-001 PEMETREXED DISODIUM EQ 100MG BASE/4ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD 2022-07-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214408-002 PEMETREXED DISODIUM EQ 500MG BASE/20ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD 2022-07-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214408-003 PEMETREXED DISODIUM EQ 850MG BASE/34ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD 2022-07-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214408-004 PEMETREXED DISODIUM EQ 1GM BASE/40ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD 2022-07-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N214408-001 PEMETREXED DISODIUM EQ 100MG BASE/4ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD 2022-07-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214408-002 PEMETREXED DISODIUM EQ 500MG BASE/20ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD 2022-07-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214408-003 PEMETREXED DISODIUM EQ 850MG BASE/34ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD 2022-07-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214408-004 PEMETREXED DISODIUM EQ 1GM BASE/40ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD 2022-07-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214408-001 PEMETREXED DISODIUM EQ 100MG BASE/4ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-07-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214408-002 PEMETREXED DISODIUM EQ 500MG BASE/20ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-07-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214408-003 PEMETREXED DISODIUM EQ 850MG BASE/34ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-07-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214408-004 PEMETREXED DISODIUM EQ 1GM BASE/40ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-07-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214408-001 PEMETREXED DISODIUM EQ 100MG BASE/4ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-07-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214408-002 PEMETREXED DISODIUM EQ 500MG BASE/20ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-07-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214408-003 PEMETREXED DISODIUM EQ 850MG BASE/34ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-07-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214408-004 PEMETREXED DISODIUM EQ 1GM BASE/40ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-07-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214408-001 PEMETREXED DISODIUM EQ 100MG BASE/4ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-07-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214408-002 PEMETREXED DISODIUM EQ 500MG BASE/20ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-07-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214408-003 PEMETREXED DISODIUM EQ 850MG BASE/34ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-07-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214408-004 PEMETREXED DISODIUM EQ 1GM BASE/40ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-07-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214408-001 PEMETREXED DISODIUM EQ 100MG BASE/4ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-07-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214408-002 PEMETREXED DISODIUM EQ 500MG BASE/20ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-07-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214408-003 PEMETREXED DISODIUM EQ 850MG BASE/34ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-07-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214408-004 PEMETREXED DISODIUM EQ 1GM BASE/40ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-07-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214408-001 PEMETREXED DISODIUM EQ 100MG BASE/4ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-07-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214408-002 PEMETREXED DISODIUM EQ 500MG BASE/20ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-07-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214408-003 PEMETREXED DISODIUM EQ 850MG BASE/34ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-07-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214408-004 PEMETREXED DISODIUM EQ 1GM BASE/40ML (EQ 25MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-07-19 5bbf6a4d5a75…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 16729-522-05 16729052205 1 VIAL in 1 CARTON (16729-522-05) > 20 mL in 1 VIAL 1 vial 2022-08-26 0000-00-00 No No Current 16729-522-28 16729052228 1 VIAL in 1 CARTON (16729-522-28) > 34 mL in 1 VIAL 1 vial 2022-08-26 0000-00-00 No No Current 16729-522-35 16729052235 1 VIAL in 1 CARTON (16729-522-35) > 40 mL in 1 VIAL 1 vial 2022-08-26 0000-00-00 No No Current 16729-522-64 16729052264 1 VIAL in 1 CARTON (16729-522-64) > 4 mL in 1 VIAL 1 vial 2022-08-26 0000-00-00 No No Current