Home NDC 63323-597 Deferoxamine
Product NDC 63323-597
11-digit product format 633230597
Labeler code 63323
Product ID 63323-597_6e384a23-a8c4-455a-b84b-847393d491e6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name DEFEROXAMINE MESYLATE
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler Fresenius Kabi USA, LLC
Application ANDA078718
Marketing category ANDA
Marketing start 2009-12-15
Substance DEFEROXAMINE MESYLATE
Active strength 95 mg/mL
Pharmacologic classes Iron Chelating Activity [MoA], Iron Chelator [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 42 .
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 A078718-001 DEFEROXAMINE MESYLATE DEFEROXAMINE MESYLATE 500MG/VIAL INJECTABLE / INJECTION AP 2009-09-15 A078718-002 DEFEROXAMINE MESYLATE DEFEROXAMINE MESYLATE 2GM/VIAL INJECTABLE / INJECTION AP 2009-09-15
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 · 84 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 2026-08-18 06:07:40 2026-07 A078718-001 DEFEROXAMINE MESYLATE 500MG/VIAL INJECTABLE / INJECTION AP 2009-09-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078718-002 DEFEROXAMINE MESYLATE 2GM/VIAL INJECTABLE / INJECTION AP 2009-09-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078718-001 DEFEROXAMINE MESYLATE 500MG/VIAL INJECTABLE / INJECTION AP 2009-09-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078718-002 DEFEROXAMINE MESYLATE 2GM/VIAL INJECTABLE / INJECTION AP 2009-09-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078718-001 DEFEROXAMINE MESYLATE 500MG/VIAL INJECTABLE / INJECTION AP 2009-09-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078718-002 DEFEROXAMINE MESYLATE 2GM/VIAL INJECTABLE / INJECTION AP 2009-09-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078718-001 DEFEROXAMINE MESYLATE 500MG/VIAL INJECTABLE / INJECTION AP 2009-09-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078718-002 DEFEROXAMINE MESYLATE 2GM/VIAL INJECTABLE / INJECTION AP 2009-09-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078718-001 DEFEROXAMINE MESYLATE 500MG/VIAL INJECTABLE / INJECTION AP 2009-09-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078718-002 DEFEROXAMINE MESYLATE 2GM/VIAL INJECTABLE / INJECTION AP 2009-09-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078718-001 DEFEROXAMINE MESYLATE 500MG/VIAL INJECTABLE / INJECTION AP 2009-09-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078718-002 DEFEROXAMINE MESYLATE 2GM/VIAL INJECTABLE / INJECTION AP 2009-09-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078718-001 DEFEROXAMINE MESYLATE 500MG/VIAL INJECTABLE / INJECTION AP 2009-09-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078718-002 DEFEROXAMINE MESYLATE 2GM/VIAL INJECTABLE / INJECTION AP 2009-09-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078718-001 DEFEROXAMINE MESYLATE 500MG/VIAL INJECTABLE / INJECTION AP 2009-09-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078718-002 DEFEROXAMINE MESYLATE 2GM/VIAL INJECTABLE / INJECTION AP 2009-09-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078718-001 DEFEROXAMINE MESYLATE 500MG/VIAL INJECTABLE / INJECTION AP 2009-09-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078718-002 DEFEROXAMINE MESYLATE 2GM/VIAL INJECTABLE / INJECTION AP 2009-09-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078718-001 DEFEROXAMINE MESYLATE 500MG/VIAL INJECTABLE / INJECTION AP 2009-09-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078718-002 DEFEROXAMINE MESYLATE 2GM/VIAL INJECTABLE / INJECTION AP 2009-09-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078718-001 DEFEROXAMINE MESYLATE 500MG/VIAL INJECTABLE / INJECTION AP 2009-09-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078718-002 DEFEROXAMINE MESYLATE 2GM/VIAL INJECTABLE / INJECTION AP 2009-09-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078718-001 DEFEROXAMINE MESYLATE 500MG/VIAL INJECTABLE / INJECTION AP 2009-09-15 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078718-002 DEFEROXAMINE MESYLATE 2GM/VIAL INJECTABLE / INJECTION AP 2009-09-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078718-001 DEFEROXAMINE MESYLATE 500MG/VIAL INJECTABLE / INJECTION AP 2009-09-15 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078718-002 DEFEROXAMINE MESYLATE 2GM/VIAL INJECTABLE / INJECTION AP 2009-09-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078718-001 DEFEROXAMINE MESYLATE 500MG/VIAL INJECTABLE / INJECTION AP 2009-09-15 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078718-002 DEFEROXAMINE MESYLATE 2GM/VIAL INJECTABLE / INJECTION AP 2009-09-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078718-001 DEFEROXAMINE MESYLATE 500MG/VIAL INJECTABLE / INJECTION AP 2009-09-15 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A078718-002 DEFEROXAMINE MESYLATE 2GM/VIAL INJECTABLE / INJECTION AP 2009-09-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078718-001 DEFEROXAMINE MESYLATE 500MG/VIAL INJECTABLE / INJECTION AP 2009-09-15 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078718-002 DEFEROXAMINE MESYLATE 2GM/VIAL INJECTABLE / INJECTION AP 2009-09-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078718-001 DEFEROXAMINE MESYLATE 500MG/VIAL INJECTABLE / INJECTION AP 2009-09-15 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A078718-002 DEFEROXAMINE MESYLATE 2GM/VIAL INJECTABLE / INJECTION AP 2009-09-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078718-001 DEFEROXAMINE MESYLATE 500MG/VIAL INJECTABLE / INJECTION AP 2009-09-15 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A078718-002 DEFEROXAMINE MESYLATE 2GM/VIAL INJECTABLE / INJECTION AP 2009-09-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078718-001 DEFEROXAMINE MESYLATE 500MG/VIAL INJECTABLE / INJECTION AP 2009-09-15 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A078718-002 DEFEROXAMINE MESYLATE 2GM/VIAL INJECTABLE / INJECTION AP 2009-09-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078718-001 DEFEROXAMINE MESYLATE 500MG/VIAL INJECTABLE / INJECTION AP 2009-09-15 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A078718-002 DEFEROXAMINE MESYLATE 2GM/VIAL INJECTABLE / INJECTION AP 2009-09-15 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Deferoxamine
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEFEROXAMINE MESYLATE 95 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination V9TKO7EO6K Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1731345 Internal RxNorm lookup 1731350 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 63323-597-10 Deferoxamine 1 in 1 BOX INJECTION, POWDER, LYOPHILIZED, 1 8 63323-597-10 Deferoxamine 5.3 mL in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 5.3 8
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DEFEROXAMINE MESYLATE ACTIVE INGREDIENT V9TKO7EO6K DEFEROXAMINE (DEFEROXAMINE MESYLATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [APP PHARMACEUTICALS, LLC] 4 DEFEROXAMINE ACTIVE MOIETY J06Y7MXW4D DEFEROXAMINE (DEFEROXAMINE MESYLATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [APP PHARMACEUTICALS, LLC] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63323-597 DEFEROXAMINE (DEFEROXAMINE MESYLATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 8 Current NDC, Legacy NDC, 2 package rows 20250330_d91e16df-8daa-4cd2-86a2-273eaa2446e0.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 63323-597-10 63323059710 1 VIAL in 1 BOX (63323-597-10) / 5.3 mL in 1 VIAL 1 vial 2009-12-15 0000-00-00 No No Current