Home NDC 63323-142-12 Ifosfamide
Product NDC 63323-142
Requested package NDC 63323-142-12
11-digit product format 633230142
Labeler code 63323
Product ID 63323-142_8f166a04-4395-4ea1-8eda-98274f1bfec3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name IFOSFAMIDE
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Fresenius Kabi USA, LLC
Application ANDA076078
Marketing category ANDA
Marketing start 2003-01-28
Substance IFOSFAMIDE
Active strength 1 g/1
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A076078-001 IFOSFAMIDE IFOSFAMIDE 1GM/VIAL INJECTABLE / INJECTION AP RS 2002-05-28 A076078-002 IFOSFAMIDE IFOSFAMIDE 3GM/VIAL INJECTABLE / INJECTION AP RS 2002-05-28
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 A076078-001 IFOSFAMIDE 1GM/VIAL INJECTABLE / INJECTION AP RS 2002-05-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076078-002 IFOSFAMIDE 3GM/VIAL INJECTABLE / INJECTION AP RS 2002-05-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 A076078-001 IFOSFAMIDE 1GM/VIAL INJECTABLE / INJECTION AP RS 2002-05-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076078-002 IFOSFAMIDE 3GM/VIAL INJECTABLE / INJECTION AP RS 2002-05-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076078-001 IFOSFAMIDE 1GM/VIAL INJECTABLE / INJECTION AP RS 2002-05-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076078-002 IFOSFAMIDE 3GM/VIAL INJECTABLE / INJECTION AP RS 2002-05-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076078-001 IFOSFAMIDE 1GM/VIAL INJECTABLE / INJECTION AP RS 2002-05-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076078-002 IFOSFAMIDE 3GM/VIAL INJECTABLE / INJECTION AP RS 2002-05-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076078-001 IFOSFAMIDE 1GM/VIAL INJECTABLE / INJECTION AP RS 2002-05-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076078-002 IFOSFAMIDE 3GM/VIAL INJECTABLE / INJECTION AP RS 2002-05-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076078-001 IFOSFAMIDE 1GM/VIAL INJECTABLE / INJECTION AP RS 2002-05-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076078-002 IFOSFAMIDE 3GM/VIAL INJECTABLE / INJECTION AP RS 2002-05-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076078-001 IFOSFAMIDE 1GM/VIAL INJECTABLE / INJECTION AP RS 2002-05-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076078-002 IFOSFAMIDE 3GM/VIAL INJECTABLE / INJECTION AP RS 2002-05-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076078-001 IFOSFAMIDE 1GM/VIAL INJECTABLE / INJECTION AP RS 2002-05-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076078-002 IFOSFAMIDE 3GM/VIAL INJECTABLE / INJECTION AP RS 2002-05-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076078-001 IFOSFAMIDE 1GM/VIAL INJECTABLE / INJECTION AP RS 2002-05-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076078-002 IFOSFAMIDE 3GM/VIAL INJECTABLE / INJECTION AP RS 2002-05-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076078-001 IFOSFAMIDE 1GM/VIAL INJECTABLE / INJECTION AP RS 2002-05-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076078-002 IFOSFAMIDE 3GM/VIAL INJECTABLE / INJECTION AP RS 2002-05-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076078-001 IFOSFAMIDE 1GM/VIAL INJECTABLE / INJECTION AP RS 2002-05-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076078-002 IFOSFAMIDE 3GM/VIAL INJECTABLE / INJECTION AP RS 2002-05-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076078-001 IFOSFAMIDE 1GM/VIAL INJECTABLE / INJECTION AP RS 2002-05-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076078-002 IFOSFAMIDE 3GM/VIAL INJECTABLE / INJECTION AP RS 2002-05-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076078-001 IFOSFAMIDE 1GM/VIAL INJECTABLE / INJECTION AP RS 2002-05-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076078-002 IFOSFAMIDE 3GM/VIAL INJECTABLE / INJECTION AP RS 2002-05-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076078-001 IFOSFAMIDE 1GM/VIAL INJECTABLE / INJECTION AP RS 2002-05-28 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076078-002 IFOSFAMIDE 3GM/VIAL INJECTABLE / INJECTION AP RS 2002-05-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076078-001 IFOSFAMIDE 1GM/VIAL INJECTABLE / INJECTION AP RS 2002-05-28 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076078-002 IFOSFAMIDE 3GM/VIAL INJECTABLE / INJECTION AP RS 2002-05-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076078-001 IFOSFAMIDE 1GM/VIAL INJECTABLE / INJECTION AP RS 2002-05-28 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A076078-002 IFOSFAMIDE 3GM/VIAL INJECTABLE / INJECTION AP RS 2002-05-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076078-001 IFOSFAMIDE 1GM/VIAL INJECTABLE / INJECTION AP RS 2002-05-28 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076078-002 IFOSFAMIDE 3GM/VIAL INJECTABLE / INJECTION AP RS 2002-05-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076078-001 IFOSFAMIDE 1GM/VIAL INJECTABLE / INJECTION AP RS 2002-05-28 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A076078-002 IFOSFAMIDE 3GM/VIAL INJECTABLE / INJECTION AP RS 2002-05-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076078-001 IFOSFAMIDE 1GM/VIAL INJECTABLE / INJECTION AP RS 2002-05-28 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A076078-002 IFOSFAMIDE 3GM/VIAL INJECTABLE / INJECTION AP RS 2002-05-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076078-001 IFOSFAMIDE 1GM/VIAL INJECTABLE / INJECTION AP RS 2002-05-28 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A076078-002 IFOSFAMIDE 3GM/VIAL INJECTABLE / INJECTION AP RS 2002-05-28 74a2ff9319b5…
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 Ifosfamide
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength IFOSFAMIDE 1 g/1
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1791593 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 63323-142-10 Ifosfamide 1 in 1 VIAL, SINGLE-DOSE INJECTION, POWDER, LYOPHILIZED, 1 5 63323-142-10 Ifosfamide 1 in 1 BOX INJECTION, POWDER, LYOPHILIZED, 1 5
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded IFOSFAMIDE ACTIVE INGREDIENT UM20QQM95Y IFOSFAMIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [APP PHARMACEUTICALS, LLC] 1 IFOSFAMIDE ACTIVE INGREDIENT UM20QQM95Y IFOSFAMIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 1 IFOSFAMIDE ACTIVE MOIETY UM20QQM95Y IFOSFAMIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [APP PHARMACEUTICALS, LLC] 1 IFOSFAMIDE ACTIVE MOIETY UM20QQM95Y IFOSFAMIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 1 BENZYL ALCOHOL INACTIVE INGREDIENT LKG8494WBH IFOSFAMIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [APP PHARMACEUTICALS, LLC] 1 BENZYL ALCOHOL INACTIVE INGREDIENT LKG8494WBH IFOSFAMIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63323-142 IFOSFAMIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 4 Current NDC, Legacy NDC, 2 package rows 20241019_a311a947-7b78-4226-bfe0-f4aa0be20e27.zip 63323-142 IFOSFAMIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 3 Current NDC, Legacy NDC 20241019_fb7f49af-ffe9-4969-a69c-8ed14dd0616b.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 · 1 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 63323-142-12 63323014212 1 VIAL, SINGLE-DOSE in 1 BOX (63323-142-12) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE 2003-01-28 0000-00-00 No No Current