Home NDC 0143-9531 Ifosfamide
Product NDC 0143-9531
11-digit product format 001439531
Labeler code 0143
Product ID 0143-9531_517c3bf6-41f5-4199-a17e-1f46b120cb1e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ifosfamide
Dosage form INJECTION
Route INTRAVENOUS
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA076619
Marketing category ANDA
Marketing start 2017-06-10
Substance IFOSFAMIDE
Active strength 50 mg/mL
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 A076619-001 IFOSFAMIDE IFOSFAMIDE 1GM/20ML (50MG/ML) INJECTABLE / INJECTION AP 2011-06-29 A076619-002 IFOSFAMIDE IFOSFAMIDE 3GM/60ML (50MG/ML) INJECTABLE / INJECTION AP 2011-06-29
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 A076619-001 IFOSFAMIDE 1GM/20ML (50MG/ML) INJECTABLE / INJECTION AP 2011-06-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076619-002 IFOSFAMIDE 3GM/60ML (50MG/ML) INJECTABLE / INJECTION AP 2011-06-29 84e616aacf4f…2026-08-18 06:07:40 2026-07 A076619-001 IFOSFAMIDE 1GM/20ML (50MG/ML) INJECTABLE / INJECTION AP 2011-06-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076619-002 IFOSFAMIDE 3GM/60ML (50MG/ML) INJECTABLE / INJECTION AP 2011-06-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076619-001 IFOSFAMIDE 1GM/20ML (50MG/ML) INJECTABLE / INJECTION AP 2011-06-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076619-002 IFOSFAMIDE 3GM/60ML (50MG/ML) INJECTABLE / INJECTION AP 2011-06-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076619-001 IFOSFAMIDE 1GM/20ML (50MG/ML) INJECTABLE / INJECTION AP 2011-06-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076619-002 IFOSFAMIDE 3GM/60ML (50MG/ML) INJECTABLE / INJECTION AP 2011-06-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076619-001 IFOSFAMIDE 1GM/20ML (50MG/ML) INJECTABLE / INJECTION AP 2011-06-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076619-002 IFOSFAMIDE 3GM/60ML (50MG/ML) INJECTABLE / INJECTION AP 2011-06-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076619-001 IFOSFAMIDE 1GM/20ML (50MG/ML) INJECTABLE / INJECTION AP 2011-06-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076619-002 IFOSFAMIDE 3GM/60ML (50MG/ML) INJECTABLE / INJECTION AP 2011-06-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076619-001 IFOSFAMIDE 1GM/20ML (50MG/ML) INJECTABLE / INJECTION AP 2011-06-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076619-002 IFOSFAMIDE 3GM/60ML (50MG/ML) INJECTABLE / INJECTION AP 2011-06-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076619-001 IFOSFAMIDE 1GM/20ML (50MG/ML) INJECTABLE / INJECTION AP 2011-06-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076619-002 IFOSFAMIDE 3GM/60ML (50MG/ML) INJECTABLE / INJECTION AP 2011-06-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076619-001 IFOSFAMIDE 1GM/20ML (50MG/ML) INJECTABLE / INJECTION AP 2011-06-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076619-002 IFOSFAMIDE 3GM/60ML (50MG/ML) INJECTABLE / INJECTION AP 2011-06-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076619-001 IFOSFAMIDE 1GM/20ML (50MG/ML) INJECTABLE / INJECTION AP 2011-06-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076619-002 IFOSFAMIDE 3GM/60ML (50MG/ML) INJECTABLE / INJECTION AP 2011-06-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076619-001 IFOSFAMIDE 1GM/20ML (50MG/ML) INJECTABLE / INJECTION AP 2011-06-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076619-002 IFOSFAMIDE 3GM/60ML (50MG/ML) INJECTABLE / INJECTION AP 2011-06-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076619-001 IFOSFAMIDE 1GM/20ML (50MG/ML) INJECTABLE / INJECTION AP 2011-06-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076619-002 IFOSFAMIDE 3GM/60ML (50MG/ML) INJECTABLE / INJECTION AP 2011-06-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076619-001 IFOSFAMIDE 1GM/20ML (50MG/ML) INJECTABLE / INJECTION AP 2011-06-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076619-002 IFOSFAMIDE 3GM/60ML (50MG/ML) INJECTABLE / INJECTION AP 2011-06-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076619-001 IFOSFAMIDE 1GM/20ML (50MG/ML) INJECTABLE / INJECTION AP 2011-06-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076619-002 IFOSFAMIDE 3GM/60ML (50MG/ML) INJECTABLE / INJECTION AP 2011-06-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076619-001 IFOSFAMIDE 1GM/20ML (50MG/ML) INJECTABLE / INJECTION AP 2011-06-29 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076619-002 IFOSFAMIDE 3GM/60ML (50MG/ML) INJECTABLE / INJECTION AP 2011-06-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076619-001 IFOSFAMIDE 1GM/20ML (50MG/ML) INJECTABLE / INJECTION AP 2011-06-29 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A076619-002 IFOSFAMIDE 3GM/60ML (50MG/ML) INJECTABLE / INJECTION AP 2011-06-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076619-001 IFOSFAMIDE 1GM/20ML (50MG/ML) INJECTABLE / INJECTION AP 2011-06-29 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076619-002 IFOSFAMIDE 3GM/60ML (50MG/ML) INJECTABLE / INJECTION AP 2011-06-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076619-001 IFOSFAMIDE 1GM/20ML (50MG/ML) INJECTABLE / INJECTION AP 2011-06-29 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A076619-002 IFOSFAMIDE 3GM/60ML (50MG/ML) INJECTABLE / INJECTION AP 2011-06-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076619-001 IFOSFAMIDE 1GM/20ML (50MG/ML) INJECTABLE / INJECTION AP 2011-06-29 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A076619-002 IFOSFAMIDE 3GM/60ML (50MG/ML) INJECTABLE / INJECTION AP 2011-06-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076619-001 IFOSFAMIDE 1GM/20ML (50MG/ML) INJECTABLE / INJECTION AP 2011-06-29 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A076619-002 IFOSFAMIDE 3GM/60ML (50MG/ML) INJECTABLE / INJECTION AP 2011-06-29 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 50 mg/mL
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1791597 Internal RxNorm lookup 1791599 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 0143-9531-01 Ifosfamide 1 in 1 BOX INJECTION 1 11 0143-9531-01 Ifosfamide 20 mL in 1 VIAL INJECTION 20 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0143-9531 IFOSFAMIDE INJECTION [HIKMA PHARMACEUTICALS USA INC.] 10 Current NDC, Legacy NDC, 2 package rows 20240504_c90ab05f-8fe5-437e-a1c0-8b11ef63291e.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 Units Marketing start Marketing end Sample Exclude flag Status 0143-9531-01 00143953101 1 VIAL in 1 BOX (0143-9531-01) / 20 mL in 1 VIAL 1 vial 2017-06-10 0000-00-00 No No Current