Home NDC 48818-001-01 Folotyn
Product NDC 48818-001
Requested package NDC 48818-001-01
11-digit product format 488180001
Labeler code 48818
Product ID 48818-001_dc6e58a9-4f26-460b-b387-41e524d3f9a6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name pralatrexate
Dosage form INJECTION
Route INTRAVENOUS
Labeler Acrotech Biopharma LLC
Application NDA022468
Marketing category NDA
Marketing start 2009-09-24
Marketing end 0000-00-00
Substance PRALATREXATE
Active strength 20 mg/mL
Pharmacologic classes Folate Analog Metabolic Inhibitor [EPC]
NDC exclude flag No
Listing certified through 2022-12-31
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 N022468-001 FOLOTYN PRALATREXATE 20MG/ML (20MG/ML) SOLUTION / INTRAVENOUS AP RLD 2009-09-24 N022468-002 FOLOTYN PRALATREXATE 40MG/2ML (20MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2009-09-24
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 3 · 82 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 2026-02-19 14:30 UTC 2026-02 N022468-001 FOLOTYN 20MG/ML (20MG/ML) SOLUTION / INTRAVENOUS AP RLD 2009-09-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022468-002 FOLOTYN 40MG/2ML (20MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2009-09-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022468-001 FOLOTYN 20MG/ML (20MG/ML) SOLUTION / INTRAVENOUS AP RLD 2009-09-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022468-002 FOLOTYN 40MG/2ML (20MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2009-09-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022468-001 FOLOTYN 20MG/ML (20MG/ML) SOLUTION / INTRAVENOUS AP RLD 2009-09-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022468-002 FOLOTYN 40MG/2ML (20MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2009-09-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022468-001 FOLOTYN 20MG/ML (20MG/ML) SOLUTION / INTRAVENOUS AP RLD 2009-09-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022468-002 FOLOTYN 40MG/2ML (20MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2009-09-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022468-001 FOLOTYN 20MG/ML (20MG/ML) SOLUTION / INTRAVENOUS RLD 2009-09-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022468-002 FOLOTYN 40MG/2ML (20MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2009-09-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022468-001 FOLOTYN 20MG/ML (20MG/ML) SOLUTION / INTRAVENOUS RLD 2009-09-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022468-002 FOLOTYN 40MG/2ML (20MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2009-09-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022468-001 FOLOTYN 20MG/ML (20MG/ML) SOLUTION / INTRAVENOUS RLD 2009-09-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022468-002 FOLOTYN 40MG/2ML (20MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2009-09-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022468-001 FOLOTYN 20MG/ML (20MG/ML) SOLUTION / INTRAVENOUS RLD 2009-09-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022468-002 FOLOTYN 40MG/2ML (20MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2009-09-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022468-001 FOLOTYN 20MG/ML (20MG/ML) SOLUTION / INTRAVENOUS RLD 2009-09-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022468-002 FOLOTYN 40MG/2ML (20MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2009-09-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022468-001 FOLOTYN 20MG/ML (20MG/ML) SOLUTION / INTRAVENOUS RLD 2009-09-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022468-002 FOLOTYN 40MG/2ML (20MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2009-09-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022468-001 FOLOTYN 20MG/ML (20MG/ML) SOLUTION / INTRAVENOUS RLD 2009-09-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022468-002 FOLOTYN 40MG/2ML (20MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2009-09-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022468-001 FOLOTYN 20MG/ML (20MG/ML) SOLUTION / INTRAVENOUS RLD 2009-09-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022468-002 FOLOTYN 40MG/2ML (20MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2009-09-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022468-001 FOLOTYN 20MG/ML (20MG/ML) SOLUTION / INTRAVENOUS RLD 2009-09-24 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022468-002 FOLOTYN 40MG/2ML (20MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2009-09-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022468-001 FOLOTYN 20MG/ML (20MG/ML) SOLUTION / INTRAVENOUS RLD 2009-09-24 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N022468-002 FOLOTYN 40MG/2ML (20MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2009-09-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022468-001 FOLOTYN 20MG/ML (20MG/ML) SOLUTION / INTRAVENOUS RLD 2009-09-24 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022468-002 FOLOTYN 40MG/2ML (20MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2009-09-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022468-001 FOLOTYN 20MG/ML (20MG/ML) SOLUTION / INTRAVENOUS RLD 2009-09-24 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022468-002 FOLOTYN 40MG/2ML (20MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2009-09-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022468-001 FOLOTYN 20MG/ML (20MG/ML) SOLUTION / INTRAVENOUS RLD 2009-09-24 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022468-002 FOLOTYN 40MG/2ML (20MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2009-09-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022468-001 FOLOTYN 20MG/ML (20MG/ML) SOLUTION / INTRAVENOUS RLD 2009-09-24 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022468-002 FOLOTYN 40MG/2ML (20MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2009-09-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022468-001 FOLOTYN 20MG/ML (20MG/ML) SOLUTION / INTRAVENOUS RLD 2009-09-24 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N022468-002 FOLOTYN 40MG/2ML (20MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2009-09-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022468-001 FOLOTYN 20MG/ML (20MG/ML) SOLUTION / INTRAVENOUS RLD 2009-09-24 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N022468-002 FOLOTYN 40MG/2ML (20MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2009-09-24 782e0a99824c…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 5 · 192 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022468-001 7622470 2025-05-31 U-1015 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022468-001 8299078 2025-05-31 U-1004 2012-12-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022468-002 7622470 2025-05-31 U-1015 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022468-002 8299078 2025-05-31 U-1004 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022468-001 7622470 2025-05-31 U-1015 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022468-001 8299078 2025-05-31 U-1004 2012-12-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022468-002 7622470 2025-05-31 U-1015 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022468-002 8299078 2025-05-31 U-1004 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022468-001 7622470 2025-05-31 U-1015 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022468-001 8299078 2025-05-31 U-1004 2012-12-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022468-002 7622470 2025-05-31 U-1015 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022468-002 8299078 2025-05-31 U-1004 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022468-001 7622470 2025-05-31 U-1015 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022468-001 8299078 2025-05-31 U-1004 2012-12-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022468-002 7622470 2025-05-31 U-1015 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022468-002 8299078 2025-05-31 U-1004 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022468-001 7622470 2025-05-31 U-1015 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022468-001 8299078 2025-05-31 U-1004 2012-12-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022468-002 7622470 2025-05-31 U-1015 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022468-002 8299078 2025-05-31 U-1004 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022468-001 7622470 2025-05-31 U-1015 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022468-001 8299078 2025-05-31 U-1004 2012-12-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022468-002 7622470 2025-05-31 U-1015 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022468-002 8299078 2025-05-31 U-1004 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022468-001 7622470 2025-05-31 U-1015 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022468-001 8299078 2025-05-31 U-1004 2012-12-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022468-002 7622470 2025-05-31 U-1015 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022468-002 8299078 2025-05-31 U-1004 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022468-001 7622470 2025-05-31 U-1015 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022468-001 8299078 2025-05-31 U-1004 2012-12-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022468-002 7622470 2025-05-31 U-1015 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022468-002 8299078 2025-05-31 U-1004 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022468-001 7622470 2025-05-31 U-1015 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022468-001 8299078 2025-05-31 U-1004 2012-12-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022468-002 7622470 2025-05-31 U-1015 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022468-002 8299078 2025-05-31 U-1004 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022468-001 7622470 2025-05-31 U-1015 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022468-001 8299078 2025-05-31 U-1004 2012-12-19 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022468-002 7622470 2025-05-31 U-1015 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022468-002 8299078 2025-05-31 U-1004 79d66fd596c7…
FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 48818-001-01 2023-04-18 These highlights do not include all the information needed to use FOLOTYN ® safely and effectively. See full prescribing information for FOLOTYN. FOLOTYN (pralatrexate injection), for intravenous use Initial U.S. Approval: 2009 48818-001-02 2023-04-18 These highlights do not include all the information needed to use FOLOTYN ® safely and effectively. See full prescribing information for FOLOTYN. FOLOTYN (pralatrexate injection), for intravenous use Initial U.S. Approval: 2009 48818-001-01 2023-01-30 These highlights do not include all the information needed to use FOLOTYN ® safely and effectively. See full prescribing information for FOLOTYN. FOLOTYN (pralatrexate injection), for intravenous use Initial U.S. Approval: 2009 48818-001-02 2023-01-30 These highlights do not include all the information needed to use FOLOTYN ® safely and effectively. See full prescribing information for FOLOTYN. FOLOTYN (pralatrexate injection), for intravenous use Initial U.S. Approval: 2009 48818-001-01 2021-10-08 These highlights do not include all the information needed to use FOLOTYN ® safely and effectively. See full prescribing information for FOLOTYN. FOLOTYN (pralatrexate injection), for intravenous use Initial U.S. Approval: 2009 48818-001-02 2021-10-08 These highlights do not include all the information needed to use FOLOTYN ® safely and effectively. See full prescribing information for FOLOTYN. FOLOTYN (pralatrexate injection), for intravenous use Initial U.S. Approval: 2009 48818-001-01 2021-01-29 These highlights do not include all the information needed to use FOLOTYN ® safely and effectively. See full prescribing information for FOLOTYN. FOLOTYN (pralatrexate injection), for intravenous use Initial U.S. Approval: 2009 48818-001-02 2021-01-29 These highlights do not include all the information needed to use FOLOTYN ® safely and effectively. See full prescribing information for FOLOTYN. FOLOTYN (pralatrexate injection), for intravenous use Initial U.S. Approval: 2009
DailyMed Socrata Ingredients# 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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 48818-001-01 48818000101 1 VIAL, SINGLE-USE in 1 CARTON (48818-001-01) > 1 mL in 1 VIAL, SINGLE-USE 2009-09-24 2023-06-30 No No Current