Home NDC 0338-3991 IFEX
Product NDC 0338-3991
11-digit product format 003383991
Labeler code 0338
Product ID 0338-3991_56f50d8e-7c87-4119-a7dc-bfd77fa3dcec
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ifosfamide
Dosage form INJECTION, POWDER, FOR SOLUTION
Route INTRAVENOUS
Labeler Baxter Healthcare Corporation
Application NDA019763
Marketing category NDA
Marketing start 1988-12-30
Substance IFOSFAMIDE
Active strength 1 g/20mL
Pharmacologic classes Alkylating Activity [MoA], Alkylating Drug [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 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date N019763-001 IFEX IFOSFAMIDE 1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION AP RLD 1988-12-30 N019763-002 IFEX IFOSFAMIDE 3GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION AP RLD 1988-12-30 N019763-003 IFEX/MESNEX KIT IFOSFAMIDE; MESNA 1GM/VIAL;100MG/ML INJECTABLE / INJECTION 1992-10-10 N019763-004 IFEX/MESNEX KIT IFOSFAMIDE; MESNA 3GM/VIAL;100MG/ML INJECTABLE / INJECTION 1992-10-10
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.
Product history page 1 of 5 · 172 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 N019763-001 IFEX 1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION AP RLD 1988-12-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N019763-002 IFEX 3GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION AP RLD 1988-12-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N019763-003 IFEX/MESNEX KIT 1GM/VIAL;100MG/ML INJECTABLE / INJECTION 1992-10-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N019763-004 IFEX/MESNEX KIT 3GM/VIAL;100MG/ML INJECTABLE / INJECTION 1992-10-10 84e616aacf4f…2026-08-18 06:07:40 2026-07 N019763-001 IFEX 1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION AP RLD 1988-12-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019763-002 IFEX 3GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION AP RLD 1988-12-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019763-003 IFEX/MESNEX KIT 1GM/VIAL;100MG/ML INJECTABLE / INJECTION 1992-10-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019763-004 IFEX/MESNEX KIT 3GM/VIAL;100MG/ML INJECTABLE / INJECTION 1992-10-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N019763-001 IFEX 1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION AP RLD 1988-12-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019763-002 IFEX 3GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION AP RLD 1988-12-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019763-003 IFEX/MESNEX KIT 1GM/VIAL;100MG/ML INJECTABLE / INJECTION 1992-10-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019763-004 IFEX/MESNEX KIT 3GM/VIAL;100MG/ML INJECTABLE / INJECTION 1992-10-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019763-001 IFEX 1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION AP RLD 1988-12-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019763-002 IFEX 3GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION AP RLD 1988-12-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019763-003 IFEX/MESNEX KIT 1GM/VIAL;100MG/ML INJECTABLE / INJECTION 1992-10-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019763-004 IFEX/MESNEX KIT 3GM/VIAL;100MG/ML INJECTABLE / INJECTION 1992-10-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019763-001 IFEX 1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION AP RLD 1988-12-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019763-002 IFEX 3GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION AP RLD 1988-12-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019763-003 IFEX/MESNEX KIT 1GM/VIAL;100MG/ML INJECTABLE / INJECTION 1992-10-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019763-004 IFEX/MESNEX KIT 3GM/VIAL;100MG/ML INJECTABLE / INJECTION 1992-10-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019763-001 IFEX 1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION AP RLD 1988-12-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019763-002 IFEX 3GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION AP RLD 1988-12-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019763-003 IFEX/MESNEX KIT 1GM/VIAL;100MG/ML INJECTABLE / INJECTION 1992-10-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019763-004 IFEX/MESNEX KIT 3GM/VIAL;100MG/ML INJECTABLE / INJECTION 1992-10-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019763-001 IFEX 1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION AP RLD 1988-12-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019763-002 IFEX 3GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION AP RLD 1988-12-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019763-003 IFEX/MESNEX KIT 1GM/VIAL;100MG/ML INJECTABLE / INJECTION 1992-10-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019763-004 IFEX/MESNEX KIT 3GM/VIAL;100MG/ML INJECTABLE / INJECTION 1992-10-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019763-001 IFEX 1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION AP RLD 1988-12-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019763-002 IFEX 3GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION AP RLD 1988-12-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019763-003 IFEX/MESNEX KIT 1GM/VIAL;100MG/ML INJECTABLE / INJECTION 1992-10-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019763-004 IFEX/MESNEX KIT 3GM/VIAL;100MG/ML INJECTABLE / INJECTION 1992-10-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019763-001 IFEX 1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION AP RLD 1988-12-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019763-002 IFEX 3GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION AP RLD 1988-12-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019763-003 IFEX/MESNEX KIT 1GM/VIAL;100MG/ML INJECTABLE / INJECTION 1992-10-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019763-004 IFEX/MESNEX KIT 3GM/VIAL;100MG/ML INJECTABLE / INJECTION 1992-10-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019763-001 IFEX 1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION AP RLD 1988-12-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019763-002 IFEX 3GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION AP RLD 1988-12-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019763-003 IFEX/MESNEX KIT 1GM/VIAL;100MG/ML INJECTABLE / INJECTION 1992-10-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019763-004 IFEX/MESNEX KIT 3GM/VIAL;100MG/ML INJECTABLE / INJECTION 1992-10-10 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 86 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base IFEX
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength IFOSFAMIDE 1 g/20mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination UM20QQM95Y Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1791588 Internal RxNorm lookup 1791591 Internal RxNorm lookup 1791593 Internal RxNorm lookup 1791595 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 0338-3991-01 IFEX 20 mL in 1 VIAL, SINGLE-DOSE INJECTION, POWDER, FOR SOLUTION 20 18 0338-3991-01 IFEX 1 in 1 CARTON INJECTION, POWDER, FOR SOLUTION 1 18
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0338-3991 IFEX (IFOSFAMIDE) INJECTION, POWDER, FOR SOLUTION [BAXTER HEALTHCARE CORPORATION] 17 Current NDC, Legacy NDC, 2 package rows 20250213_b7241707-7538-4d1a-91e7-3a25a91e0b9a.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 · 3 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 0338-3991-01 00338399101 1 VIAL, SINGLE-DOSE in 1 CARTON (0338-3991-01) / 20 mL in 1 VIAL, SINGLE-DOSE 1988-12-30 0000-00-00 No No Current