Home NDC 65219-550 Pralatrexate
Product NDC 65219-550
11-digit product format 652190550
Labeler code 65219
Product ID 65219-550_510bc71b-20e4-428a-8fc2-29c9fc20f2f3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Pralatrexate
Dosage form INJECTION
Route INTRAVENOUS
Labeler Fresenius Kabi USA, LLC
Application NDA022468
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2022-11-15
Substance PRALATREXATE
Active strength 20 mg/mL
Pharmacologic classes Folate Analog Metabolic Inhibitor [EPC]
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 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…
Additional Listing Data#
Finished product Yes
Brand name base Pralatrexate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PRALATREXATE 20 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination A8Q8I19Q20 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1796419 Internal RxNorm lookup 1796424 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 65219-550-01 Pralatrexate 1 mL in 1 VIAL, SINGLE-DOSE INJECTION 1 1 65219-550-01 Pralatrexate 1 in 1 CARTON INJECTION 1 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65219-550 PRALATREXATE INJECTION [FRESENIUS KABI USA, LLC] 1 Current NDC, Legacy NDC, 2 package rows 20221119_a5daa583-4965-4564-ad87-41ffe6c08a11.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 65219-550-01 65219055001 1 VIAL, SINGLE-DOSE in 1 CARTON (65219-550-01) / 1 mL in 1 VIAL, SINGLE-DOSE 2022-11-15 0000-00-00 No No Current