Home NDC 43598-342 Pralatrexate
Product NDC 43598-342
11-digit product format 435980342
Labeler code 43598
Product ID 43598-342_b885a7b3-a241-638d-8f27-d162c562469a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Pralatrexate
Dosage form INJECTION
Route INTRAVENOUS
Labeler Dr.Reddy's Laboratories Inc.,
Application ANDA206183
Marketing category ANDA
Marketing start 2026-03-04
Substance PRALATREXATE
Active strength 20 mg/mL
Pharmacologic classes Folate Analog Metabolic Inhibitor [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
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 A206183-001 PRALATREXATE PRALATREXATE 20MG/ML (20MG/ML) SOLUTION / INTRAVENOUS AP 2025-03-10 A206183-002 PRALATREXATE PRALATREXATE 40MG/2ML (20MG/ML) SOLUTION / INTRAVENOUS AP 2025-03-10
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.
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 A206183-001 PRALATREXATE 20MG/ML (20MG/ML) SOLUTION / INTRAVENOUS AP 2025-03-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206183-002 PRALATREXATE 40MG/2ML (20MG/ML) SOLUTION / INTRAVENOUS AP 2025-03-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206183-001 PRALATREXATE 20MG/ML (20MG/ML) SOLUTION / INTRAVENOUS AP 2025-03-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206183-002 PRALATREXATE 40MG/2ML (20MG/ML) SOLUTION / INTRAVENOUS AP 2025-03-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206183-001 PRALATREXATE 20MG/ML (20MG/ML) SOLUTION / INTRAVENOUS AP 2025-03-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206183-002 PRALATREXATE 40MG/2ML (20MG/ML) SOLUTION / INTRAVENOUS AP 2025-03-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206183-001 PRALATREXATE 20MG/ML (20MG/ML) SOLUTION / INTRAVENOUS AP 2025-03-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206183-002 PRALATREXATE 40MG/2ML (20MG/ML) SOLUTION / INTRAVENOUS AP 2025-03-10 fd3edfee7708…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A206183-001 PRALATREXATE 20MG/ML (20MG/ML) SOLUTION / INTRAVENOUS AP 2025-03-10 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A206183-002 PRALATREXATE 40MG/2ML (20MG/ML) SOLUTION / INTRAVENOUS AP 2025-03-10 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Pralatrexate
Listing expiration 2027-12-31 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 43598-342-11 Pralatrexate 1 mL in 1 VIAL, SINGLE-DOSE INJECTION 1 6 43598-342-11 Pralatrexate 1 in 1 CARTON INJECTION 1 6
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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 43598-342-11 43598034211 1 VIAL, SINGLE-DOSE in 1 CARTON (43598-342-11) / 1 mL in 1 VIAL, SINGLE-DOSE 2026-03-04 No No Current