Home DailyMed b1d0dd02-ec6b-47f7-acdb-42e56d067a7b National Council for Prescription Drug Programs indexing - billing unit Drug label information. FDA.report displays public Structured Product Labeling data from DailyMed and legacy FDA.report DailyMed cache rows. This page is not medical advice, prescribing advice, or a substitute for the official label reviewed by a qualified healthcare professional. Labeling can change; when a current hydrated DailyMed SPL record is available, FDA.report shows that newer record before legacy cached files.
Manufacturer National Council for Prescription Drug Programs
Effective date 2012-07-24
Label type Indexing - Billing Unit
Version 1
Source full-release
Hydrated at 2026-06-05 02:29:30 Orange Book application contexts# All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book application contexts page 1 of 1 · 1 matching rows.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 · 86 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 N022468-001 FOLOTYN 20MG/ML (20MG/ML) SOLUTION / INTRAVENOUS AP RLD 2009-09-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022468-002 FOLOTYN 40MG/2ML (20MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2009-09-24 84e616aacf4f…2026-08-18 06:07:40 2026-07 N022468-001 FOLOTYN 20MG/ML (20MG/ML) SOLUTION / INTRAVENOUS AP RLD 2009-09-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022468-002 FOLOTYN 40MG/2ML (20MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2009-09-24 caaa826d4ba7…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…
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…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.